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The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy
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The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy

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  • 1. Title Author(s) The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy Huen, Suk-ting; 禤淑婷 Citation Issue Date URL Rights 2013 http://hdl.handle.net/10722/193054 The author retains all proprietary rights, (such as patent rights) and the right to use in future works.
  • 2. Abstract of dissertation entitled The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy Submitted by Huen Suk Ting for the degree of Master of Nursing at The University of Hong Kong in July 2013 Chemotherapy is one of the major treatments for cancer patients to cure or palliate their disease. Cancer patients experience physiological and psychological distress during chemotherapy treatment. Anxiety is the most common symptom observed in cancer patients undergoing chemotherapy. Anxiety has also proven to be highly associated with anticipatory nausea and vomiting (ANV). In the local chemotherapy day ward, almost half of the cancer patients verbalize that they feel i
  • 3. anxious and are afraid of turning up for chemotherapy due to the fear of its side effects. However, clinical measure for treating patients’ anxiety during chemotherapy is limited. One of the complementary and alternative medicines (CAM), massage therapy, becomes a useful means for cancer patients to relieve their physical and psychological distress. Yet, massage is not a routine CAM being integrated into the cancer treatment in Hong Kong, including the target center. Thus, a translational study is proposed in order to develop a massage program for cancer patients receiving chemotherapy to relieve their anxiety. A systematic search of five electronic journal databases identified 9 randomized controlled trials (RCTs) on the use of massage therapy for cancer patients in relieving their anxiety. The appraisal tool developed by the Critical Appraisal Skills Programme was used to evaluate the quality of the selected studies. The findings of the selected studies concluded that massage therapy is effective in relieving anxiety for cancer patients. A massage program is proposed to be implemented in a chemotherapy day ward. This translational research proposal will illustrate how such a massage program is planned. The implementation potential has been assessed and the potential benefits of massage do outweigh its risks and the costs of running this program. An ii
  • 4. evidence-based guideline has been developed to ensure patient safety and increase effectiveness of the massage program. The communication process with stakeholders has been planned in order to gain their support for this massage program. Staff training will be organized and a pilot study has been designed to test the feasibility of this program. An evaluation plan has also been developed to assess the effectiveness of this program. Anxiety level, measured by using State Trait Anxiety Inventory-State (STAI-S), is set as the primary patient outcome of this study. In addition, Numerical Rating Scale (NRS), rating from 0 to 10, will be used as the secondary patient outcome to measure the severity of nausea and vomiting. Lastly, the satisfaction level of patients, volunteers and nurses will be measured using a 4-point Likert scale. Therefore, the proposed massage program can be improved and refined according to the evaluation findings. It is believed that the proposed massage program can reduce anxiety for cancer patients receiving chemotherapy and thus improving their quality of life. iii
  • 5. The effect of massage therapy in relieving anxiety in cancer patients receiving chemotherapy by Huen Suk Ting Bachelor of Nursing, Registered Nurse A dissertation submitted in partial fulfillment of the requirements for the degree of Master of Nursing at The University of Hong Kong July 2013 iv
  • 6. Declaration I declare that this dissertation represents my own work, except where due acknowledgement is made, and that it has not been previously included in a theses, dissertation or report submitted to this University or to any other institution for a degree, diploma or other qualification. Signed _________________________________ Huen Suk Ting v
  • 7. Acknowledgements I would like to express my heartfelt gratitude to my supervisor Miss Idy Fu, who provided guidance and inspirations on this dissertation. Her encouragement and support throughout these two years has enabled me to complete this dissertation. I am also grateful to my Ward Manager, Mr. Rayman Wan and Advanced Practice Nurse, Miss Yuen Mei-Lin, for their sincere encouragement in my postgraduate studies. Finally, I deeply thank my family and friends for their constant love and support to complete this master programme. Huen Suk Ting vi
  • 8. Table of contents Declaration .................................................................................................................. v Acknowledgements ................................................................................................... vi Table of contents ...................................................................................................... vii Chapter 1: Introduction ............................................................................................ 1 1.1Background ..................................................................................................... 1 1.2 Affirming the need ......................................................................................... 3 1.3 Objectives and significance ............................................................................ 5 Chapter 2: Critical Appraisal ................................................................................... 8 2.1 Search strategies ............................................................................................. 8 2.1.1 Selection criteria ...................................................................................... 8 2.2 Search results .................................................................................................. 9 2.2.1 Study characteristics ................................................................................ 9 2.2.2 Methodological assessment ................................................................... 10 2.3. Summary and synthesis of data ................................................................... 14 2.3.1 Characteristics of participants ............................................................... 14 2.3.2 Selection of participants ........................................................................ 15 vii
  • 9. 2.3.3 Dropout rate .......................................................................................... 16 2.3.4 Intervention ........................................................................................... 17 2.3.5 Type and area of massage used ............................................................. 18 2.3.6 Duration and frequency of massage ...................................................... 19 2.4 Recommendation and conclusion ................................................................. 19 Chapter 3: Translation and Application ................................................................ 23 3.1 Implementation potential .............................................................................. 23 3.1.1 Transferability of the findings ............................................................... 23 3.1.1.1 Target setting .................................................................................. 23 3.1.1.2 Target audience .............................................................................. 24 3.1.1.3 Philosophy of care .......................................................................... 25 3.1.1.4 Proposed massage intervention ...................................................... 26 3.1.2 Feasibility of the innovation .................................................................. 27 3.1.2.1 Organizational and administrative support .................................... 27 3.1.2.2 Frontline staff support .................................................................... 28 3.1.2.3 Volunteers’ support ........................................................................ 30 3.1.3 Cost/Benefit ratio of the program .......................................................... 31 viii
  • 10. 3.1.3.1 Potential risks ................................................................................. 31 3.1.3.2 Potential benefits ............................................................................ 33 3.1.3.3 Cost ................................................................................................. 34 Chapter 4: Evidence-Based Practice Guideline .................................................... 37 4.1 Aim ............................................................................................................... 37 4.2 Objectives ..................................................................................................... 37 4.3 Target population ......................................................................................... 38 4.4 Recommendations ........................................................................................ 39 Recommendation 1.0 .................................................................................. 39 Recommendation 2.0 .................................................................................. 39 Recommendation 3.0 .................................................................................. 40 Recommendation 4.0 .................................................................................. 40 Chapter 5: Implementation Plan ............................................................................ 42 5.1 Communication plan .................................................................................... 42 5.1.1 Identifying stakeholders ........................................................................ 42 5.1.2 Formation of a working group .............................................................. 43 5.1.3 Communication process ........................................................................ 44 ix
  • 11. 5.2 Staff training program .................................................................................. 46 5.3 Delivery of intervention ............................................................................... 46 5.4 Pilot study ..................................................................................................... 47 5.5 Ongoing monitoring of the massage program .............................................. 48 5.6 Evaluation plan ............................................................................................. 48 5.6.1 Identifying outcomes ............................................................................. 48 5.6.2 Nature and number of clients to be involved ........................................ 50 5.6.3 Data collection and data analysis .......................................................... 51 5.6.4 Basis for as effective change of practice ............................................... 52 Chapter 6: Conclusion ............................................................................................. 53 References ................................................................................................................. 55 Appendix A: Search history .................................................................................... 64 Appendix B: Summary of search results ............................................................... 69 Appendix C: List of selected studies ...................................................................... 70 Appendix D: Appraisal tool (RCTs checklist) ....................................................... 72 Appendix E: Level of evidence ................................................................................ 76 Appendix F: Quality assessment ............................................................................. 77 x
  • 12. Appendix G: Table of evidence ............................................................................... 86 Appendix H: Table of summary for the Studies’ Results .................................... 95 Appendix I: Estimated expenses that can be saved by reducing use of potent anti-emetics ......................................................................................... 97 Appendix J: Budget plan for implementing the massage program .................... 98 Appendix K: Grade of recommendation ............................................................... 99 Appendix L: Evidence-based practice guideline of massage for cancer patients receiving chemotherapy ................................................................... 100 Appendix M: Timetable for implementation of the massage program ............ 110 Appendix N: Assessment form for the massage program .................................. 111 xi
  • 13. Chapter 1: Introduction Cancer patients experience physiological and psychological distress during chemotherapy treatment (Icomonou, et al., 2004). Anxiety is the most common symptom observed in cancer patients undergoing chemotherapy. A non-pharmacological method, massage therapy, is suggested for those patients to reduce their level of anxiety, decreasing the side effects of chemotherapy and improving their quality of life. This chapter will illustrate the needs and significance of implementing massage interventions for cancer patients in Hong Kong in order to reduce their anxiety. 1.1 Background Cancer is a stressful event for patients as it is a life-threatening and chronic illness requiring life-long monitoring for disease recurrence. According to the Department of Health, cancer is the most leading cause of death in Hong Kong, accounting for 31.2% of all deaths in 2009. Moreover, The Hong Kong Cancer Registry (2007) reported that the cancer burden in our population is increasing. It is shown by the continually rising number of new cancer cases, a rate of around 2% every year, and the steadily increasing life expectancy for both sexes in Hong Kong in the past 25 years. As well, the survival time for cancer patients has been lengthened by advanced medical technology and aggressive cancer treatments (Schreier, et al., 1
  • 14. 2004). However, the increasing number of cancer survivors also implies a longer life with a longer treatment period, including surgery, chemotherapy, radiotherapy and target therapy, causing cancer patients to suffer for longer periods of and more severe side effects from cancer treatments (Listing, et al., 2009). These lengthy treatments can cause emotional distress for cancer patients such as anxiety, sense of guilt and low self-esteem, due to the uncertainty of treatment and disease progression (Lin, et al., 2011). Thus, such impact becomes an important issue for cancer patients’ quality of life (Listing, et al., 2009). The use of chemotherapy in cancer patients is strongly correlated with cancer survival (Bender, et al., 2002). Chemotherapy can be classified into Curative Intent, to eradicate tumor cells, and Palliative Intent, to decrease tumor load and symptoms so as to prolong life. Cancer patients usually suffer from physical and psychological problems related to fatigue, anxiety and depression during chemotherapy (Icomonou, et al., 2004). Undesirable side effects such as nausea, vomiting, sleep disturbance and fatigue further increase patients’ psychological distress (Lin, et al., 2011). A study showed that 15-40% of cancer patients suffered from psychological disorders related to anxiety and depression during chemotherapy, and that anxiety highly contributed to the incidence of pre-therapy and post-therapy nausea and vomiting (Molassiotis, et al., 2002). 2
  • 15. There has been an increase in cancer patients seeking complementary and alternative medicine (CAM) in addition to conventional treatments to improve common treatment side effects and disease symptoms over the past decade (DiGianni, et al., 2002). The National Center for Complementary and Alternative Medicine (NCCAM) (2010) defines CAM as “a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine’. A survey conducted in Taiwan showed that 98.1% of cancer patients receiving chemotherapy simultaneously used CAM such as diets, massage and herbal medicine (Yang, et al., 2008). The Hong Kong Breast Cancer Registry (2011) also reported that 33.5% of breast cancer patients received CAM. Massage is one of the common CAM practices employed to relieve anxiety, pain and nausea for cancer patients and has been widely used as a treatment for over 3000 years (Quattrin, et al., 2006). Massage is defined as ‘a rhythmic form of touch done by a specially trained person to communicate empathy to the recipient, thus, producing positive psychological and physiological states of being’ (Tappan, 1980). 1.2 Affirming the need In the local chemotherapy day ward, almost half of the cancer patients admitted for receiving chemotherapy verbalize that they feel anxious and are afraid of turning up for chemotherapy due to the fear of its side effects. Those patients manifest anxiety 3
  • 16. by developing hand tremors, restlessness, nausea and vomiting before administration of chemotherapy. This type of nausea and vomiting is referred to as ‘anticipatory nausea and vomiting (ANV)’. ANV is defined as developing nausea and vomiting during the 24 hour period prior to chemotherapy administration (Andrykowski, et al., 1985). It is reported that approximately 30% of cancer patients develop ANV before their chemotherapy treatment (Morrow, et al., 1998). Anxiety has proven to be a significant predisposing factor which is highly associated with ANV and is difficult to be controlled by pharmacological treatment (Roscoe, et al., 2011). As a result, patients still experience discomfort and suffer from chemotherapy side effects despite the use of anxiolytic agents (Billhult, et al., 2007). Eventually, these anticipatory problems and undesirable side effects further exaggerate the level of anxiety that is already present with the cancer diagnosis, and therefore worsening the patient’s quality of life (Lin, et al., 2011). Some cancer patients even refuse or defer chemotherapy due to the fear of its associated side effects. This delay in receiving treatment then lowers their chance of recovery (Dibble, et al., 2003). Currently, patients’ anxiety and ANV can only be improved by reassurance from nurses, pharmacological use and referring symptomatic cases to a clinical psychologist. However, time available for nurse counseling is limited due to a 4
  • 17. shortage of manpower. Moreover, the choice of anxiolytic and anti-emetic drugs are limited and not recommended since their side effects may induce drowsiness, further worsening the patients’ fatigue and concentration (Traeger, et al., 2012). On the other hand, the clinical psychologist will only be referred in the target clinic if the cancer patient experiences excessive anxiety causing a psychological disorder. The waiting period for such a consultation is often more than two weeks once a referral is recommended. A local survey (Williams, et al., 2010) reported that massage becomes a useful means for cancer patients in dealing with such physically and psychologically stressful treatments for enhancing their quality of life. However, massage is not a routine CAM being integrated into cancer treatment in Hong Kong, including the target center. Discussions about massage therapy between cancer patients and health care professions are also uncommon in the target center. To date, no study has been conducted in Hong Kong on the effectiveness of massage therapy in reducing anxiety on cancer patients undergoing chemotherapy. Therefore, a literature review must be performed to examine the effectiveness of massage therapy for cancer patients receiving chemotherapy in relieving anxiety and thus reducing the severity of ANV. 1.3 Objectives and significance The burden of psychological distress, anxiety and depression in cancer 5
  • 18. patients undergoing chemotherapy cannot be neglected. Ineffective coping of anxiety may cause anxiety disorders and depression, which has been estimated to be 4 times more common in cancer patients compared to the general population (Corbin, 2005). Anxiety may also exacerbate cancer patients’ physical symptoms such as nausea, vomiting, insomnia, fatigue and decreased appetite, which will further impair their quality of life (Corbin, 2005). Massage therapy is believed to help cancer patients to interrupt the cycle of distress and induce a relaxation response, thus, improving their quality of life (Ahles, et al., 1999). It is also believed to have a boosting effect on the immune system and an increase in serotonin level which reduces muscle tension and anxiety (Billhult, et al., 2007). Current oncology treatment has evolved from merely cancer killing to enhancing patients’ comfort throughout their treatment and recovery phases (Currin & Meister, et al., 2008). There is a growing need in CAM to augment cancer care. However, discussion on the use of massage between nurses and cancer patients remains uncommon in most clinical settings (Ahn, et al., 2006). Health care professionals are an important and trustful source of information on medical treatment for cancer patients (Li, et al., 2010). With the increasing use of massage therapy within the community, nurses have an obligation to provide information and service for cancer 6
  • 19. patients to reduce their anxiety and mood disturbance, assisting them in going through the treatment period. Therefore, the research question is posed; ‘Is massage therapy effective in reducing anxiety in adult cancer patients undergoing chemotherapy?’ The objectives of this dissertation are as follows: 1. To review studies on the effectiveness of massage in reducing anxiety of adult cancer patients undergoing chemotherapy. 2. To critically appraise, summarize and synthesize the research findings from selected studies. 3. To formulate evidence-based guideline on implementing massage therapy for cancer patients undergoing chemotherapy. 4. To assess the implementation potential of the proposed massage program. 5. To develop an implementation and evaluation plan for the proposed program. 7
  • 20. Chapter 2: Critical Appraisal In this chapter, a literature review is performed with the detailed search strategies described. Then, a critical appraisal is done on the selected studies, and recommendations are made after summarizing and synthesizing the data extracted from those studies. 2.1 Search strategies Both electronic and manual searches were performed from 29th July 2012 to 30th August 2012 to identify eligible studies for a comprehensive literature review. Five electronic databases: Medline (OvidSP) (1946 to July Week 3 2012), CINAHL Plus (EBSCOHost) (1967 to 2012), British Nursing Index (ProQuest), The Cochrane library and The PsycINFO (1800s to 2012), were used. Several keywords were used to limit the number of literature results related to the chosen topic. The keywords used were grouped according to population (Cancer, neoplasm, oncology, carcinoma, malignancy), treatment (chemotherapy), intervention (massage therapy, complementary treatment, alternative therapies and alternative medicine), and outcome (anxiety, anxiety disorder, mood disturbance, psychological discomfort, relaxation, anticipatory nausea and anticipatory vomiting). 2.1.1 Selection criteria Inclusion and exclusion criteria were developed to select eligible studies. For 8
  • 21. the inclusion criteria, studies must be randomized controlled trials (RCTs). RCTs have the highest level of evidence to examine the effectiveness of the studied intervention (Petrisor & Bhandari, 2007). Studies should be written in English since the author is unable to translate the studies appropriately and precisely into English. The participants of the studies should be cancer patients aged 18 or above, as the target population is adult cancer patients. Moreover, massage therapy should be the only intervention assigned to the intervention group. Any combinations of massage with other innovations such as aromatherapy or reflexology as the only intervention were not included to avoid any confounding effect. Also, the included studies had to have at least one outcome measure relating to anxiety. Any unrelated massage such as prostatic massage and carotid massage were also excluded. 2.2 Search results Details of the search history and a summary of the search results are shown in appendix A and B respectively. After manual screening using the inclusion and exclusion criteria and discarding duplicated ones, nine studies were identified. A manual search from the reference list was also performed and no further studies were found. A list of the selected papers is shown in appendix C. 2.2.1 Study characteristics All of the nine selected papers were published from 1999 to 2011. The 9
  • 22. majority of these were conducted in western countries: three in the USA (Ahles, et al., 1999; Hernandez, et al., 2004; Post-White, et al., 2003), two in the UK (Soden, et al., 2004; Sharp, et al., 2010), one in Germany (Listing, et al., 2010), two in Sweden (Billhult, et al., 2007; Billhult, et al., 2008) and one in Taiwan (Jane, et al., 2011). Massage therapy was the only different treatment used between the intervention and control groups in all studies. Participants of both the intervention and control groups within each study (N=9) were given the service in the same environment such as a quiet and private room to minimize any confounding factors altering the study’s outcomes. 2.2.2 Methodological assessment The quality of the studies was evaluated by the Critical Appraisal Skills Programme (Guyatt, Sackett, & Cook, 1993, 1994). Its RCTs checklist, which consists of 10 questions, was used as the appraisal tool to guide the review. Detail of the RCTs checklist is shown in appendix D. Then, the level of evidence for all selected studies was classified using the Scottish Intercollegiate Guidelines Network (SIGN) (SIGN, 2008). Details are provided in appendix E. All studies stated clearly-focused research questions including the population (cancer patients), intervention (massage therapy) and the outcomes related to anxiety. All studies are RCTs which was considered to have the most powerful and convincing 10
  • 23. evidence on the causal effect between interventions and study outcomes (Petrisor & Bhandari, 2007). All participants in the nine studies were appropriately allocated to either intervention groups or control groups by randomization. Seven studies clearly stated their method used for randomization. Four studies were using sealed opaque envelopes (Soden, et al., 2004; Bullhult, et al., 2007; Billhult, et al., 2008; Sharp, et al., 2010); one study used a computer program (Jane, et al., 2011); one study used a simple randomization list (Listing, et al., 2010) and one study used the flip of a coin (Hernandez-Reif, et al., 2004). All studies compared baseline demographic variables between intervention and control groups at the entry of the trials. Only one study showed significantly more women in the control group than the intervention group after randomization (Soden, et al., 2004). Nevertheless, their baseline assessment scores of the measured outcomes were compared and showed no significant difference between groups. It was not feasible to ‘blind’ participants for the group assignments. They would know whether they were in the control group receiving usual care, or the intervention group receiving massage therapy. However, an informed consent was obtained from the participants prior to the treatment allocation. Concealment was achieved. Three studies had enough participants to have a statistical power of 80% 11
  • 24. (Hernandez-Reif, et al., 2004; Post-White, et al., 2003; Billhult, et al., 2008), and two studies had enough participants to reach the power of 95% (Sharp, et al., 2010; Jane, et al., 2011). However, one study’s sample size was less than expected (Soden, et al., 2004), and three studies did not set minimum sample size to achieve certain statistical power (Ahles, et al., 1999; Listing, et al., 2010; Bullhult, et al., 2007). Those with insufficient sample size might cause difficulties in establishing a conclusion as to whether the outcome was a real effect from massage therapy or due to some characteristic of the participants, causing a risk for inducing type II errors (Soden, et al., 2004). All nine studies used self-assessment tools for primary outcome data collection. Some studies (N=5) used one-dimensional tools such as State Trait Anxiety Inventory (STAI), visual analogue scale (VAS) on relaxation, mood and nausea (Ahles, et al., 1999; Hernandez-Reif, et al., 2004; Billhult, et al., 2007; Billhult, et al., 2008; Jane, et al., 2011). The reliability and validity of these tools are well established (Spieberger, 1983; Lee & Kieckhefer, 1989). A two-dimensional tool, the Hospital Anxiety and Depression Scale (HADS) was also used to measure the change in anxiety and depression level for the participants (Soden, et al., 2004; Sharp, et al., 2010; Billhult, et al., 2007; Billhult, et al., 2008). Its validity was also verified (Zigmond & Snaith, 1983). Furthermore, some multi-dimensional tools, the 12
  • 25. Profile of Mood States (POMS), the Mood Rating Scales (MRS) and the Berlin Mood Questionnaire (BMQ) had been used to measure participants’ mood states and quality of life in 3 studies (Post-White, et al., 2003; Listing, et al., 2010; Sharp, et al., 2010). These tools consist of several subscales measuring participants’ anxiety level and their reliability was also well established (Redd, et al., 1991; Anderson, et al., 2000; Hoerhold & Klapp, 1993). All of the assessment tools used were self reported questionnaires to measure subjective feelings of anxiety. Therefore, the data can be collected without using an interviewer or data collector to decrease the risk of detection bias (Gurusamy, et al., 2009). All nine studies present their results precisely using mean change, percentage change and effect size of the scores by different well established measuring tools. All studies set 5% as the level of significance. Six studies showed the baseline scores and change in post intervention scores in the form of tables, while the other three studies (Post-White, et al., 2003; Listing, et al., 2010; Jane, et al., 2011) presented the results in the form of both tables and graphs of mean score over time. All tables and graphs were clearly presented with the p-value provided so that the effect of massage therapy at different time periods was clearly indicated. According to the above critical appraisal, three studies (Sharp, et al., 2010; Hernandez-Rief, et al., 2004; Jane, et al., 2011) were graded as the highest quality 13
  • 26. RCTs with a very low risk of bias (1++) while four studies (Ahles, et al., 1999; Post-White, et al., 2003; Listing, et al., 2010; Billhult, et al., 2007) were rated 1+ with a low risk of bias. The remaining two studies (Soden, et al., 2004; Billhult, et al., 2008) were labeled as high risk of bias (1- ). A detailed quality assessment of each selected study is shown in appendix F. 2.3 Summary and synthesis of data The contents of the selected studies were reviewed and data were extracted using tables of evidence. The tables of evidence for each study are itemized in appendix G and the summary is briefly described. Appendix H clearly shows a table of summary for the studies’ results. 2.3.1 Characteristics of participants All participants in the nine studies were cancer patients and five of them were breast cancer female patients (Sharp, et al., 2010; Hernandez-Reif, et al., 2004; Listing, et al., 2010; Billhult, et al., 2007; Billhult, et al., 2008). Also, participants in five studies were receiving chemotherapy during the study period (Ahles, et al., 1999; Sharp, et al., 2010; Post-White, et al., 2003; Billhult, et al., 2007; Jane, et al., 2011). This population is the same as that in the local setting, a chemotherapy day ward, where breast cancer patients are the majority in the population. These patients require a relatively longer treatment period, about one and a half years to receive target and 14
  • 27. conventional chemotherapy. In addition, women with breast cancer are a vulnerable group among cancer patients since they are at higher risk for depression, elevated stress and anxiety levels, and anger (Longman, et al., 1999). The mean age of participants ranged from 41 to 62.5 in eight studies except one study with a median age of 73 (Soden, et al., 2004). This is similar to the peak age group among the prevalence of cancer in Hong Kong, aged 45-64 (Hong Kong Cancer Registry, 2009). Therefore, the results of the studies should be applicable to the local clinical setting. 2.3.2 Selection of participants Although no adverse effect was reported in all the selected studies, some literature showed that massage might increase the risk of fractures and dislocation, hemorrhage, hematoma and dislodging of deep vein thrombosis in certain populations (Corbin, 2005). Participants in all the studies required doctor approval before entering the studies. In addition, assessment had been done in some studies to exclude cases with underlying medical conditions such as lymphoedema, inflamed skin in the area of therapy, anticoagulants problems, thrombocytopenia, spinal cord compression syndrome and deep vein thrombosis (Hernandez-Reif, et al., 2004; Listing, et al., 2010; Jane, et al., 2011). Moreover, Post-White, et al. (2010) stated that the massage technique and the area of massage should be modified and adjusted to avoid tumor or 15
  • 28. surgical sites. The study also suggested that the depth of touch should be limited according to individual tolerance (Post-White, et al., 2010). Therefore, assessment should be performed prior to the proposed massage therapy. Furthermore, an informed consent should be obtained from participants prior to massage therapy to ensure that participants understand the purpose of the program and the risk of the intervention, even though the adverse effect of massage therapy reported to be very low in all the studies. 2.3.3 Dropout rate The dropout rate among the selected studies ranged from 0-29%. Eight studies had a dropout rate less than 20%. Some studies tried to minimize the possibility of dropout by offering the control group to receive complimentary massages (Hernandez-Rief, et al., 2004; Jane, et al., 2011) and progressive muscle relaxation (Listing, et al., 2010) after completion of the studies. Eventually their dropout rates were lowered to 0% (Hernandez-Rief, et al., 2004), 6.9% (Jane, et al., 2011) and 14.7% (Listing, et al., 2010). One study (Post-White, et al., 2003) had a dropout rate of 29% and it explained that the participants left the study due to their advancing disease causing a subsequent change in their treatment plan or the participants died before completion of the study. Nevertheless, no differences had been detected from the baseline data between adherers and dropouts in the study. 16
  • 29. In addition, all dropout participants in all the studies were included to which they were originally allocated for intention-to-treat analysis so that all participants were accounted for at the conclusion to ensure the validity of the results (Montori & Guyatt, 2001). 2.3.4 Intervention The overall effectiveness of massage therapy in reducing anxiety for cancer patients has been demonstrated among the selected studies. After implementing massage therapy for cancer patients, two of them found that the mean STAI-S scores have been significantly decreased by >10 (P<0.05) (Ahles, et al., 1999; Hernandez-Reif, et al., 2004). One study had significant decrease in median HAD scores by 2 after massage therapy (P≦0.05) (Soden, et al., 2004). Sharp, et al. (2010) also found that the mean difference of MRS relaxation subscale had significantly reduced by ≧18 (P≦0.02). Post-White,et al. (2003) showed that the mean difference of POMS mood disturbance and anxiety subscales had improved by ≧3 significantly (P≦0.02). In addition, Listing, et al.’s study (2010) calculated the effect size of BMQ-anxious depression as 0.9 (P<0.05) in the study while Jane, et al.’s study (2011) got a significant improvement in VAS- relaxation in their study with effect size ≧ 0.45 (P≦0.03). Only 2 studies failed to prove the effect of massage in reducing anxiety (Billhult, et al., 2007; Billhult, et al., 2008). However, the mean change of 17
  • 30. VAS nausea in Billhult, et al. study (2007) had significantly improved (P=0.025). Although the STAI-S score in Billhult, et al.’s study (2008) was not significantly improved, this score from their intervention group had still been greatly reduced. Small sample size was the major cause for these diverse results, recruiting only 19 (Billhult, et al., 2007) and 11 (Billhult, et al., 2008) participants into each treatment group in their studies. Small sample size might alter the results caused by confounding factors such as age and disease prognosis of the participants other than the effect of the interventions (Gurusamy, et al., 2009). Nevertheless, none of the studies showed any negative effect of massage therapy on cancer patients. 2.3.5 Type and area of massage used Majority of the studies (N= 7) used the Swedish technique to implement massage therapy and five of them showed significant effect in anxiety reduction (Ahles, et al., 1999; Hernandez-Reif, et al., 2004; Post-White, et al., 2003; Listing, et al., 2010; Jane, et al., 2011). Swedish massage is the technique of using smooth, long, rhythmical strokes and gentle kneading of the body. This type of massage is soft and comfortable enough for cancer patients (Billhult, et al., 2007). Five studies applied massage over the participants’ whole body and upper part of body which showed an effective improvement in anxiety level (Hernandez-Reif, et al., 2004; Ahles, et al., 1999; Post-White, et al., 2003; Listing, et al., 2010; Jane, et al., 18
  • 31. 2011). However, only one study was conducted in a Chinese country, Taiwan (Jane, et al., 2011). 2.3.6 Duration and frequency of massage Majority of the studies (N=6) set the duration of the massage therapy as 20-30 minutes (Soden, et al., 2004; Ahles, et al., 1999; Hernandez-Reif, et al., 2004; Listing, et al., 2010; Billhult, et al., 2007; Billhult, et al., 2008). Three of the studies (Ahles, et al., 1999; Hernandez-Reif, et al., 2004; Listing, et al., 2010) showed significant improvement in anxiety and one of them showed a reduction in the sense of nausea (Billhult, et al., 2007). The frequency of massage sessions among the studies was discrete. Some studies performed massages weekly over 4 to 8 weeks (Soden, et al., 2004; Sharp, et al., 2010; Post-White, et al., 2003) while some studies performed massages two to three times weekly over 3 to 5 weeks (Ahles, et al., 1999; Hernandez-Reif, et al., 2004; Listing, et al., 2010; Billhult, et al., 2008). One study implemented massage therapy concurrently with chemotherapy for 5 cycles (Billhult, et al., 2007); and one study performed massage on 3 consecutive days (Jane, et al., 2011). 2.4 Recommendation and conclusion After summarizing and synthesizing the data from the selected studies, it can be concluded that massage therapy is proven to be effective in relieving anxiety in 19
  • 32. cancer patients. As such, it is proposed to implement a massage program in the target chemotherapy day ward to reduce anxiety in cancer patients receiving chemotherapy. Swedish massage will be used in the proposed massage program. Traditionally, Chinese people are less physically expressive than people in western countries. They might feel as though they are being violated by others due to excessive physical contact. The studies of Billhult, et al. (2007) and Billhult, et al. (2008) also stated that participants preferred to receive massage on their foot and lower leg rather than hand and lower arm if choice was provided. Moreover, patients in the target center will receive chemotherapy via peripheral vein over their hands and lower arms. Therefore, foot and lower leg massage is preferred to avoid cancer patients requiring frequent change in position or feeling uncomfortable with intimate touch during massage. 20-30 minutes is seen as suitable for the target population since the administration duration of chemotherapy is 30 minutes. Setting the duration of massage therapy as 20-30 minutes can minimize a prolonged stay in the day ward for the target participants. In addition, frequent hospital visits may cause fatigue for participants and thus affect the outcomes and dropout rate of a massage program. Therefore, the frequency of massage proposed for the target chemotherapy day ward will be concurrent with participants’ chemotherapy regimen, which is one session 20
  • 33. every 3 weeks. Although all of the studies used self reported questionnaires to measure the subjective feeling of anxiety for cancer patients, the measuring tools used amongst the studies varied. Anxiety possesses a multi-dimensional effect that correlates and affects a person’s mood and quality of life, however, a one-dimensional measuring tool is preferred to provide a simple, reliable and direct measure for the proposed innovation (Seligman, et al., 2001). The STAI consists of two 20-items instrument with a four point Likert Scale to measure current anxiety level (state anxiety), and the tendency to experience anxiety (trait anxiety) (Spielberger, 1983). The higher score in STAI indicates the high level of anxiety. The STAI-state portion (STAI-S) is recommended to measure the current change in anxiety level before and after the proposed massage therapy. Its reliability and validity have been well proven and the internal consistency alpha coefficients of the state portion ranged from 0.82 to 0.92 (Spieberger, 1983). In addition, the Chinese version of the STAI-S, as shown in appendix N, is readily available and its reliability and validity has been well established (Shek, 1993). Thus, it will be used for the proposed massage program as the target participants are all Chinese. A detailed evaluation plan will be elaborated in chapter 4. In conclusion, it is proposed to implement a massage program, providing a 21
  • 34. 30-minute Swedish massage on foot and lower legs for cancer patients undergoing each cycle of chemotherapy in a local chemotherapy day ward to relieve their anxiety and ANV so as to improve their quality of life. 22
  • 35. Chapter 3: Translation and Application The literature review in previous chapters showed that massage therapy is effective in reducing anxiety for cancer patients receiving chemotherapy. The implementation potential of this innovation should be examined before it can be translated and applied to the target local setting (Polit & Beck, 2008). In this chapter, the transferability and the feasibility of the massage innovation are examined. The potential risks, benefits and the cost of the proposed program are analyzed to determine the worthiness of implementation in the target setting. 3.1 Implementation potential 3.1.1 Transferability of the findings 3.1.1.1 Target setting Massage therapy is proposed to be implemented in a chemotherapy day ward which is an out-patient setting managed under the Clinical Oncology Department of a public hospital. Cancer patients must be seen and reviewed by oncologists during each follow-up to ensure their suitability for each cycle of chemotherapy. Cancer patients will then be admitted to the day ward on the same day or the day after the follow-up, if they are suitable for chemotherapy. The target setting consists of twenty-eight chemotherapy chairs. The proposed innovation will be implemented on those chairs since massage can be applied to the 23
  • 36. cancer patient in a seated position, as was the case in three reviewed studies (Billhult, et al., 2007; Billhult, et al., 2008; Sharp, et al., 2010). There are six nurses responsible for chemotherapy administration in the chemotherapy day ward. Due to their heavy workload, it might not be feasible for them to perform the massage in the proposed program. The cancer patient resource centre of the target hospital will allocate a total of 25 volunteers. Five volunteers will stay in the day ward each day to provide counseling for the cancer patients. These volunteers are also cancer patients who have completely recovered. They are well trained and qualified with more than 3 years experience on communicating and taking care of cancer patients. Some of the reviewed studies (Ahles, et al., 1999; Billhult, et al., 2007; Hernandez-Reif, et al., 2004) recruited self-trained nurse’s aides to perform massages, resulting in promising outcomes. Therefore, the proposed program will train volunteers to perform the massage to cancer patients who are waiting for their chemotherapy in the day ward, under nurses’ supervision. 3.1.1.2 Target audience Patients from both the reviewed studies and the target setting are cancer patients including hematology malignancy and solid tumor with or without metastasis. According to the annual statistics in the target setting, there were 11,692 cancer 24
  • 37. patients admitted to the target setting with the mean age of 58 last year. This is similar to those from the reviewed studies that the mean age ranged from 41 to 62.5 years old. One reviewed study (Jane, et al., 2011) was conducted in Taiwan in which all participants were Chinese with 76% believed in Buddhism or Taoism. This is also comparable to the target patients as the majority of them are Chinese and also believe in Buddhism or Taoism. A descriptive study (Williams, et al., 2010) reported that massage is one of the complimentary methods for adult cancer patients in Hong Kong to relieve discomfort caused by chemotherapy. In addition, four reviewed studies involved participants that were currently receiving chemotherapy (Ahles, et al., 1999; Billhult, et al., 2007; Jane, et al., 2011; Post-White, et al., 2003). Therefore, the target patients in the proposed setting have similar characteristics as the patients in the reviewed studies. 3.1.1.3 Philosophy of care As the core value of the Hospital Authority is to provide ‘client-centered care’, healthcare professionals should not only give patients life-saving treatment but also empower them to regain their health, optimizing their quality of life. Cancer patients are not merely facing physical distress but they also experience psychological distress such as anxiety during their chemotherapy treatment (Ahles, et al., 1999; Bullhult, et al., 2008). 25
  • 38. The massage innovation falls within this prevailing philosophy of care. As cancer patients are seeking alternative ways to improve their quality of life, oncology nurses have an obligation to ensure cancer patient’s quality of life in their cancer trajectory. Therefore, both reviewed studies and the target hospital share the same philosophy of care. 3.1.1.4 Proposed massage intervention Six reviewed studies used 20 minute to 45 minute Swedish massage showing significant improvement in reducing cancer patient’s anxiety (Ahles, et al., 1999; Billhult, et al., 2007; Hernandez-Reif, et al., 2004; Jane, et al., 2011; Listing, et al., 2010; Post-White, et al., 2003). They believed that Swedish massage with its light strokes and kneading technique is soft and gentle enough for cancer patients. Therefore, Swedish massage will be used as the massage technique in the proposed program. The waiting time for cancer patients to start chemotherapy infusion after admission is about 30 minutes to 1 hour in the day ward. Therefore, the duration of the proposed massage is to be 30 minutes before chemotherapy infusion, to avoid prolonging the patient’s length of stay. In the target setting, the total sessions for a majority of chemotherapy treatments are 4 to 6 sessions. As massage therapy will be given to cancer patients during their 26
  • 39. second chemotherapy session, a maximum of 5 sessions will be given to each eligible cancer patient or until their chemotherapy treatment is completed. The preparation, implementation and evaluation of the proposed innovation will last for one year. A pilot study will be conducted to assess the feasibility and examine any difficulties encountered during implementing the program. Details of the pilot study will be discussed in chapter 4. 3.1.2 Feasibility of the innovation 3.1.2.1 Organizational and administrative support The administrators of the Clinical Oncology Department include the Chief of Service (Clinical Oncology), Consultant, Clinical Oncologists, Department Operation Manager of Clinical Oncology, Nurse Consultant, Ward Manager and the Project Manager of the cancer patient resource center who supervises the volunteers. The atmosphere of promoting evidence-based practice in the department is positive. The Nurse Consultant and the Ward Manager always offer opportunities for staff to attend conferences to update their professional knowledge. They share the latest research findings with colleagues and develop evidence-based guidelines for clinical use. As the target hospital is a teaching hospital of a university in Hong Kong, the stakeholders are well aware of the importance of evidence-based practices to improve 27
  • 40. cancer treatment and service for patients. It is foreseeable that such a supporting and experienced team will give positive support for implementing the proposed program. 3.1.2.2 Frontline staff support There are a total of 15 nurses, including an advanced practice nurse, registered nurses and enrolled nurses, being rotated in the outpatient clinics within the department. These frontline staff have already noted that anxiety is one of the most common reactions among patients undergoing chemotherapy. They report spending most of their time reassuring and persuading anxious patients to receive chemotherapy after their admission. The proposed massage program can reduce anxiety and thus comfort anxious patients. This will then shorten nurses’ time spent with the symptomatic patients. In addition, nurses in the target setting are experienced in implementing evidence-based practices. They understand and even welcome using new evidence-based practices and its benefits for patients. The APN of the target setting also pays due attention to implementing evidence-based practices. She continually arranges lessons for nurses to update their clinical knowledge and practices related to oncology care based on literature evidences. For example, she has illustrated the best practice of central venous catheter care in order to reduce risk of infection last year. 28
  • 41. All frontline nurses demonstrate supportive attitudes to change of current practices whenever there is a need. However, there are two possible factors that may undermine efforts to implement the proposed massage program. Firstly, nurses need to spend time to attend training sessions for the massage program during their working hours. It may increase the workload of the other nurses who remain in the clinic during the training session. Secondly, the change in current practice may cause stress to nurses because of the unfamiliar guidelines and workflow of the massage program. In order to avoid disturbing the daily operation of the out-patient clinics and chemotherapy day ward during the training sessions, two identical two-hour training sessions will be held in the conference room of the department. All nurses and the volunteers recruited will be invited to attend one of the training sessions. Also, the training sessions will be held on Friday from 3:30 pm to 5:30pm when it is less busy in all clinics and chemotherapy day ward. The Advanced Practice Nurse, experienced in performing massage to cancer patients, and the programme coordinator will be responsible for the trainings. Patient benefits, program logistics, nursing assessment, evaluation method of the innovation and the massage guideline will all be introduced in the training programme. In order to minimize nurses’ workload, it will be explained that they are only required to perform the assessment, using a self-designed 29
  • 42. assessment form, and supervise the volunteers who perform the massage. Details of the training sessions will be explained in Chapter 4. Furthermore, a working group including 1 advanced practice nurse and 6 senior registered nurses (RNs) will be established to organize, implement and evaluate the massage program. The working group will supervise nurses and the trained volunteers, and monitor the progress of the massage program. All nurses will be welcome to consult the working group if they have any query during the implementation period to minimize their stress due to this unfamiliar massage program. 3.1.2.3 Volunteers’ support Massagists for the proposed program will be chosen from the volunteer staff at the Patient Resource Center. The goal of the center is to ensure the best-possible service towards optimizing cancer patients’ quality of life. The center’s manager and the volunteers are supportive of utilizing evidence-based practices in their services. It is their common practices to organize evidence-based workshops such as peer support groups and role playing for cancer patients. This is intended to provide psychological support and to strengthen their self care ability. They are also familiar with introducing some complimentary methods, with evidence support, to cancer patients in order to relieve physical discomfort. 30
  • 43. One element of concern stems from the fact that these volunteers are all cancer patients who have completely recovered. Acting as the massagists in this program may become physically demanding to the volunteers. Therefore, discussions will be held with the project manager to invite eligible volunteers to join the massage program. Ten volunteers will be recruited and trained. During the implementation period, volunteers will only need to perform not more than 2 massages each day to prevent overwhelming them. A detailed implementation plan will be described in Chapter 4. A further source of potential stress for volunteers may result from being unfamiliar with the massage technique. Therefore, it will be guaranteed that training will be given before implementing the program and that nurses will supervise them during the massage intervention. Furthermore, regular meetings with nurses and volunteers will be conducted for sharing opinions and raising concerns so that any difficulties can be tackled in advance. 3.1.3 Cost/Benefit ratio of the program 3.1.3.1 Potential risks All nine reviewed studies claimed that massage therapy is a safe treatment with no adverse effects reported. Moreover, there is no evidence that massage therapy can spread cancer from its local region to distal body area (Corbin, 2005). Swedish 31
  • 44. massage is relatively safe when compared to other vigorous massages such as deep body massage which might cause fracture, haematoma and pulmonary embolism (Ernst, 2003). Even though complications related to Swedish massage is rare, the possibility of developing bruising, hematoma and pain cannot be ignored (Corbin, 2005). Therefore, training for identifying and managing possible complications should be given to nurses. Nursing assessment is also essential to exclude cancer patients with contraindication such as coagulation disorder and deep vein thrombosis from participating in the program (Billhult, et al., 2007; Post-White, et al., 2003). The evidence-based guideline for massages will act as a reference for implementing the program. Trained volunteers are also required to report to the core members promptly when patients have any discomfort during massage. Medical involvement in excluding high risk patients from the program is essential to minimize risks for cancer patients receiving massage. The Oncologist’s approval for patients to receive massage therapy should be obtained during the patient’s follow-up for the second cycle of chemotherapy. Medical support from oncologists is also required for managing any massage-related complications during the implementation period. Therefore, a meeting will be arranged with all oncologists in the department to introduce this program to them. Seeking their support is 32
  • 45. necessary for identifying eligible patients for this program and managing patients with massage-related complications, should these occur. 3.1.3.2 Potential benefits As previously stated, massage therapy can greatly improve both physical and psychological distress (Corbin, 2005). A nonrandomized study (Grealish, et al., 2000) reported that even a 10 minute leg massage immediately improved pain, nausea and anxiety in cancer patients. Physiologically, Field (1998) found that massage can trigger the release of some hormones and neurotransmitters, leading to improvement in mood, severity of nausea and sleeping quality. With improvement in these physical symptoms, and hence quality of life, cancer patients are likely to complete chemotherapy treatment as planned without delaying or terminating unnecessarily (Corbin, 2005). There is an increase in cancer patients seeking information about massage therapy to relieve treatment-related discomfort. Implementing this program would enrich nurse’s professional knowledge about massage and by doing so nurses can provide a means for cancer patients to consider the information. With the target setting being able to provide a qualified massage service for cancer patients, this will enhance both holistic patient care and nurses’ job satisfaction. 33
  • 46. As massage therapy can be performed by nurses, volunteers and family members (Reaves & McManis, 2010). If this program can be proved as effective in reducing anxiety, nurses can teach patient’s families to perform massage for cancer patients themselves. Consequently, cancer patients can receive massages at home more frequently and therefore, better control the patient’s discomfort. Rapport between nurses, patients and their family members can also be enhanced from this interaction. Although implementing the program may induce extra workload for nurses, their effort in managing patients with anticipatory nausea and vomiting will then be inversely lower if patient’s anxiety level is reduced by the massage program. From observation, there are approximately half of the cancer patients admitted to the day ward behave anxiously. Considering 20% of these patients are eligible and willing to participate in this program, it is estimated that there will be 1,169 cancer patients benefiting from this program every year. 3.1.3.3 Cost Without effective intervention, cancer patients experiencing severe nausea and vomiting due to chemotherapy may suffer from dehydration or electrolyte imbalance. It may lead to not only delaying their chemotherapy treatment but also being admitted to the day ward or even to the in-patient unit for rehydration or electrolyte supplement. This causes extra admission and medical treatments for the patients during their 34
  • 47. treatment period, increasing medical expenses for cancer patients. As cancer patients are required to pay an additional $150 for every extra admission, this may increase the patients’ financial burden, on top of their current medical costs. During patients’ follow-up, if they feel nervous about chemotherapy or their nausea and vomiting was poorly controlled in the previous admission, doctors may add a potent anti-emetic, i.e. the 5-HT3-receptor antagonist on top of the usual anti-emetics. Yet, these strong anti-emetics such as Navoban are relatively expensive ($63.5/tablet) when compared with the commonly used anti-emetics such as Maxolon, ($0.08/tablet). These potent anti-emetics also carry more side effects. If implementing the massage program reduces patient’s anxiety and decreases their severity of nausea and vomiting, then the use of such costly anti-emetics will be lowered. If the use of those potent anti-emetics can even be reduced by 20% among the patients in the massage program, the medication expense can be greatly reduced. The estimated expense that can be saved is calculated in appendix I. It is estimated that $57,000 will be saved on the use of potent anti-emetics after cancer patients join the massage program. On the other hand, implementing the massage program will bear some material costs. However, these costs will be limited to stationery and massage oil since audio-visual aids and the conference venue are already available at the target setting. 35
  • 48. Assuming that there will be 1,100 cancer patients joining the massage program a year, the estimated annual budget for running the program will be $12,000. A detailed budget plan is listed in Appendix J. The necessary training and preparation for this massage program will require extra expenditures from the department. However, considering the patient benefits and the long term cost saved from using costly anti-emetics, it is worth to implement the massage program in the target setting. 36
  • 49. Chapter 4: Evidence-Based Practice Guideline The evidence-based practice (EBP) guideline is developed based on the literature review conducted in the previous chapter. It provides structural and clear information for nurses on the use of massage on adult cancer patients receiving chemotherapy to reduce anxiety in the target hospital. The level of evidence and recommendations extracted from the nine RCTs are graded according to the Scottish Intercollegiate Guideline Network (SIGN, 2008), as shown in appendix E and K respectively. A working group will be formed to include Clinical Oncologists, the Nurse Consultant and the Ward Manager to develop and review the guideline regularly to ensure its quality and applicability. The aim, objectives, target population and recommendations are extracted and shown below. A detailed EBP guideline is available in appendix L. 4.1 Aim The aim of this guideline is to implement feasible and effective massage interventions to reduce anxiety for cancer patients receiving chemotherapy in an outpatient clinic setting. 4.2 Objectives To provide a consistent framework for implementation of safe and effective massage therapy to cancer patients to reduce their anxiety from receiving chemotherapy. 37
  • 50. 4.3 Target population The massage therapy is applicable to both male and female adult cancer patients who are receiving chemotherapy in the chemotherapy day ward. Inclusive criteria - Aged 18 or above - Cantonese- and Mandarin-speaking patients who are able to read Chinese. - Cognitively competent Exclusive criteria - Coagulation disorder - Spinal cord injury - Venous thrombosis - Bone metastasis - Peripheral neuropathy - Radiation dermatitis - Open wound over lower limbs 38
  • 51. 4.4 Recommendations Recommendation 1.0 Nursing assessment should be performed to exclude high risk patients from joining the massage program. (Grade of recommendation: A) Patients with medical conditions including coagulation disorder, spinal cord injury, thrombosis, bone metastasis, peripheral neuropathy, radiation dermatitis and open wound over lower limbs are excluded from receiving massage in four of the reviewed RCTs(Hernandez-Reif, et al., 2004; Jane, et al., 2011; Sharp, et al., 2010; Listing, et al., 2010). This is necessary as these conditions may heighten the risk of massage complications such as neuropathy damage, hematoma, bleeding and dislodging of deep venous thrombosis causing embolism (Hernandez-Reif, et al, 2004; Jane, et al., 2011; Sharp, et al., 2010; Listing, et al., 2010) (1++; 1++; 1++; 1+). Recommendation 2.0 Swedish massage is recommended to perform on patient’s lower limbs. (Grade of recommendation: A) No complication such as fractures, dislocations, nerve damage and pulmonary embolism were reported from participants in seven reviewed RCTs which used Swedish massage as their intervention. (Ahles, et al., 1999; Billhult, et al., 2007; 39
  • 52. Billhult, et al., 2008; Hernandez-Reif, et al., 2004; Jane, et al., 2011; Listing, et al., 2010; Post-White, et al., 2003). (1+; 1+; 1-; 1++; 1++; 1+; 1+) Recommendation 3.0 The duration of massage therapy is recommended as 30 minutes. (Grade of recommendation: A) Six reviewed studies used 20-30 minute massage and five of them reported to have positive effects in reducing level of anxiety and sense of nausea for cancer patients (Ahles, et al., Billhult, et al., 2007; Billhult, et al., 2008; Hernandez-Reif, et al., 2004; Listing, et al., 2010; Soden, et al., 2004). The immediate short-term (30 min) benefits of massage therapy is well proved to reduce anxiety for cancer patients (Hernandez-Reif, et al., 2004; Listing, et al., 2010; Soden et al., 2004). (1++; 1+; 1- ) Recommendation 4.0 The State-Trait Anxiety Inventory (STAI-S) measuring tool should be used to measure the patient’s level of anxiety before and after the massage so as to evaluate the effectiveness of this massage program. (Grade of recommendation: A) Five reviewed RCTs used one-dimensional self assessment tools to measure the subjective feeling of anxiety for cancer patients (Ahles, et al., 1999; Billhult, et al., 40
  • 53. 2007; Bullhult, et al., 2008; Hernandez-Reif, et al., 2004; Jane, et al., 2011). Three of them used STAI-S assessment tool to measure anxiety level for cancer patients and resulted in decrease in their anxiety level (Ahles, et al., 1999; Billhult, et al., 2008; Hernandez-Reif, et al., 2004). STAI-S is a valid and reliable one-dimensional assessment tool that is short and easy for cancer patients to complete. (1+; 1-; 1++) 41
  • 54. Chapter 5: Implementation Plan An implementation plan is essential to facilitate communication and the realization of the massage innovation into the target setting. This chapter will illustrate a detailed communication, execution and evaluation plan for the massage program for cancer patients receiving chemotherapy in the target setting. 5.1 Communication plan Communication enhances dissemination of information about the innovation among the stakeholders who are the key persons affecting the success of the program (Burns and Grove, 2005). A good communication plan is needed in order to give stakeholders a better understanding of and support for the innovation. The stakeholders of this program would include the hospital administrators, frontline nurses, cancer patients, and volunteers and the manager from the patient resource centre. 5.1.1 Identifying stakeholders The Chief of Service (Clinical Oncology), the Department Operation Manager (DOM), the Nurse Consultant and the Ward Manager are the key administrators. They have the authority to endorse guidelines and interventions used in the target setting. Their approval must be obtained before implementing this massage program. Therefore, the aims, benefits and costs of this program will be explained to them 42
  • 55. through meetings and emails to gain their support. In addition, they will be consulted for opinions to revise the guidelines as necessary, given their rich experiences in implementing new programs in the target setting. Clinical oncologists are responsible for assessing eligibility of cancer patients to ensure the appropriate patients are selected to receive massage therapy. They will also provide medical support if patients develop any adverse effects due to massage therapy such as muscular pain and shortness of breath. Therefore, a meeting with all 10 oncologists will be held to explain the aims and benefits of this massage program. The frontline nurses will conduct and supervise this massage program while the volunteers, supervised by their manager from the patient resource centre will perform the massage interventions. Briefing sessions will be held to explain the purpose of this innovation to the nurses, manager and the volunteers of the resource centre in order to gain their support. Training will be provided for the nurses and volunteers with regards to the knowledge and skills about massage. Details of the briefing and the training sessions will be described in a later section. 5.1.2 Formation of a working group A working group will be established to facilitate propagation of information about this massage program to different stakeholders effectively. The group will be comprised of an advanced practice nurse (APN), who is familiar with massage and 43
  • 56. responsible for the training sessions, and six senior registered nurses, including the program coordinator. This group will be responsible for organizing, executing and evaluating the massage program. They will develop and help revising the EBP massage guidelines. They will monitor and provide knowledge and skills support for frontline nurses and volunteers when needed during the implementation period. 5.1.3 Communication process The communication process will begin with the Ward Manager and the Nurse Consultant, who are responsible to review new nursing guidelines and innovations within the department. A meeting will be held with them so that their concern can be considered and tackled in advance. The working group will convey that anxiety is the common clinical problem identified among cancer patients receiving chemotherapy. After that, the evidence-based massage programme will be introduced as a solution to minimize anxiety in those cancer patients. Training of the nurses and volunteers will also be discussed. The ward manager and nurse consultant will then be invited to give their advice about the innovation, and the working group will revise the logistics of the program accordingly. After gaining the initial support from these key personnel, the idea of this innovation can then be further disseminated to other stakeholders. The objectives of this innovation will then be explained in a formal presentation to others administrators including the Chief of Service, DOM and oncologists. The 44
  • 57. presentation will clearly elaborate the current situation of patients’ anxiety during chemotherapy. The benefits of massage will be explained with literature evidence provided. Their concerns and comments will be used to refine the innovation further. Communication with the frontline nurses is essential as they are the key persons who will conduct and monitor the massage program. A briefing session will be held to disseminate the details of the innovation by the program coordinator in the conference room of the department. The aim and benefits of the proposed program will be explained. Its workflow will be elaborated and their concerns will be considered in order to refine the programme. The manager of the patient resource centre will also be invited to join the nurses meeting. This will promote communication between them and assist in selecting eligible volunteers to join the program. As the volunteers are all cancer survivors, the selection of eligible volunteers will be based on their medical conditions. This is done to avoid overwhelming them physically due to performing massage intervention. The selected volunteers will then join other nurses in the training sessions to learn the details of the massage program. Ten volunteers will then be recruited into this programme and arranged for the training. In order to implement the program seamlessly and effectively, a timetable (appendix M) is stipulated. 45
  • 58. 5.2 Staff training program Before implementing the innovation, two identical two-hour training sessions will be held in the conference room of the department every Friday from 3:30 pm to 5:30pm. All nurses working in the chemotherapy day ward and the volunteers recruited will need to attend one of the training sessions. The APN, having rich clinical experience and knowledge in performing massage to cancer patients, will hold the training sessions. Theory, technique and benefits of massage will be explained. The logistics of the program, nursing assessment, evaluation plan and the massage guidelines will also be elaborated upon. At the end of the training session, both nurses and volunteers will be asked to demonstrate the massage technique to the APN. A checklist designed by the working group will be used for assessing their skills in order to ensure the quality of the massage technique. 5.3 Delivery of intervention Posters about the program will be placed on the notice board in the chemotherapy day ward. A leaflet with details of the massage program will be given to every patient during their admission. If the patients wish to join this program, nurse will check their eligibility according to the inclusion criteria documented in the evidence-based guideline. If the patients are eligible, nurse will fill in part 1 of the assessment form (Appendix N) and file it in the patient’s kardex. Further assessment 46
  • 59. for eligibility will be performed by oncologists during their second follow up. This is to ensure no hidden or recently developed illnesses such as venous thrombosis that are contraindicated to the massage program. Patients will join the massage program only after getting approval from the oncologists. Then, a 30-minute massage session will be performed every 3 weeks on the same day when patients return for chemotherapy. A maximum of 5 massage sessions will be given. After getting approval from the oncologists, nurses will complete part 3 of the assessment form when the patients are admitted to the chemotherapy day ward. They will explain the procedure of massage to the patients and obtain their informed consent. Patients will be asked to complete the pre-massage form on measuring their level of anxiety, nausea and vomiting. Nurses will then supervise the trained volunteers to perform massage and monitor the patient’s condition during the intervention. Immediately following the massage therapy, the same measurement will be collected from patients again. Nurses will document on patients’ kardex if they develop discomfort during the massage therapy. 5.4 Pilot study A pilot study should be conducted to test the feasibility and the logistics of this massage program so as to identify any difficulties related to implementing the program. It is proposed to conduct a pilot test in the chemotherapy day ward with 10 47
  • 60. cancer patients or setting the pilot period for one month, whichever is achieved first. The trained nurses and volunteers who will work in the day ward during the pilot period will be responsible for conducting the pilot test. Meetings with the nurses and volunteers will be conducted to share their opinions and difficulties encountered at the end of the pilot study period. Revision and refinement of the program will then be made before the full-scale implementation of this program. 5.5 Ongoing monitoring of the massage program The working group will monitor the entire innovation process continuously to ensure the massage program is properly implemented in the target setting. Meetings with nurses and volunteers will be arranged every 3 months to share their insights on the massage program. Revisions will be made accordingly. 5.6 Evaluation plan To determine if the innovation achieves its objectives or not, an outcome evaluation must be performed. 5.6.1 Identifying outcomes Anxiety level among cancer patients receiving chemotherapy is set as the primary patient outcome of this massage program. Patients’ pre and post-massage anxiety level will be measured by using the Chinese version of State Trait Anxiety Inventory-State (STAI-S) which is a reliable and validated tool measuring current 48
  • 61. change in anxiety level (Spieberger, 1983). STAI-S was also used by the reviewed studies to verify the effect of massage in reducing anxiety among cancer patients (Ahles, et al., 1999; Hernandez, et al., 2004; Bullhult, et al., 2007). The secondary patient outcome will be the change in severity of nausea and vomiting for patients during the course of massage therapy. A Numerical rating scale (NRS), rating from 0 to 10, will be used to measure both the severity of nausea and vomiting. 0 represents an absence of nausea and vomiting while 10 is an extreme level of the symptoms. This is a common self-reporting measure to quantify subjective feelings with established reliability and validity (Ahles,et al., 1999; Post-White, et al., 2003). Since anxiety is proven to be highly associated with anticipatory nausea and vomiting, measuring the severity of nausea and vomiting can also determine whether the massage program achieves its intended effect (Morrow, et al., 1998). A successful massage program requires target patients, volunteers and frontline nurses to accept and participate in this so that it can be developed and implemented effectively. Therefore, their satisfaction will be measured after the last session of massage using a 4-point Likert Scale survey. For the patients who have discontinued treatment prior to the fifth massage session, the survey will be mailed to them in order to obtain their score of satisfaction. 49
  • 62. 5.6.2 Nature and number of clients to be involved Target patients of this program are adult cancer patients including hematology malignancy and solid tumor with or without metastasis. The eligibility criteria will be cancer patients; aged 18 or above; Cantonese- or Mandarin-speaking patients who are able to read Chinese; and cognitively competent and being admitted to the chemotherapy day ward receiving chemotherapy. Patients with medical conditions such as coagulation disorder and bone metastasis will be excluded from the massage program (Hernandez, et al., 2004; Jane, et al., 2011; Sharp, et al., 2010). In order to determine whether the anxiety level of cancer patients will be reduced or not after receiving the massage interventions, an adequate sample size is required. The number of patients is calculated using the one-sample t test analysis (Russ Lenth, 2009). Taking references from the reviewed studies, a mean difference of 5 between pre- and post-test on the STAI-S score and a standard deviation of 13 will be used to calculate the sample size required (Ahles, et al., 1999; Hernandez, et al., 2004). A paired t test with alpha as 0.05 and power 80% are used. It is assumed that there will be a 5% drop out rate due to change in patients’ severity of illness causing discontinuation of chemotherapy and early withdrawal from the massage program. Therefore, the number of patients required for joining the program is 60. It is 50
  • 63. estimated to take six months to recruit 60 cancer patients and have them completed a maximum of 5 massage sessions. 5.6.3 Data collection and data analysis The massage sessions will be conducted every 3 weeks during their chemotherapy treatment. A total of five measurements in pre- and post-massage STAI-S will be obtained. STAI-S form is a 20-item inventory with each item measured on a 1-4 numeric rating scale scored from 20-80. The higher the STAI-S score means the higher the anxiety level of the patients. Since the reviewed studies reported that massage has an immediate effect on reducing anxiety for cancer patients, STAI-S scores will be measured immediately before and after each session of massage (Ahles, et al., 1999; Hernandez, et al., 2004; Listing, et al., 2010; Post-White, et al., 2003; Sharp, et al., 2010; Soden, et al., 2004). The Statistical Package for Social Sciences (SPSS) version 17.0 will be used to analyze the data. Descriptive statistics will be used to summarize patients’ demographic data. The mean STAI-S scores will be generated at each time of measurement. Two-tailed paired t-test will be used to analyze the STAI-S scores obtained to determine if the massage program can significantly decrease patients’ level of anxiety or not. 51
  • 64. To evaluate the change in severity of nausea and vomiting during the course of massage, patients will be asked to grade their feeling of nausea and vomiting by using NRS (0-10) at 0, 15 and 30 minutes after starting the massage intervention. The mean scores of NRS-nausea and NRS-vomiting at each time point will be generated respectively and presented by mean, mean difference and standard deviation using two-tailed paired t-test. The satisfaction level of patients, volunteers and nurses towards receiving or delivering the intervention will be measured using a 4-point Likert scale survey (4=totally satisfied; 3=satisfied; 2=dissatisfied; 1=totally dissatisfied). The mean satisfaction score will be calculated and compared. 5.6.4 Basis for an effective change of practice The massage program will be considered as effective if there is a statistically significant decrease in patients’ STAI-S score, NRS-nausea and NRS-vomiting after each massage session with a p-value less than 0.05. Moreover, if the mean scores of the satisfaction level among patients, volunteers and nurses are greater than 2, the massage program will be considered successful. 52
  • 65. Chapter 6: Conclusion Cancer patients are experiencing high levels of psychological and physiological distress during chemotherapy treatment. Of these patients, anxiety is the most commonly reported symptom from the target population in a local chemotherapy day ward. It has also been demonstrated that elevated anxiety increases the severity of chemotherapy side effects, anticipatory nausea and vomiting, thus, impairing cancer patients’ quality of life to a greater extent. Massage is one of the common CAM that is effective in reducing anxiety for cancer patients, non-pharmacologically. After summarizing and synthesizing the data from the 9 reviewed studies, a 30 minute Swedish massage on the lower legs is suggested to be performed on cancer patients during each cycle of chemotherapy to reduce their anxiety. An evidence-based guideline on implementing massage therapy for cancer patients undergoing chemotherapy was set to ensure patient safety and increase effectiveness in executing the massage program. A detailed implementation plan was developed to gain support from the stakeholders in the target chemotherapy day ward. Also, an evaluation plan was designed to assess the effectiveness of this program. Patients’ level of anxiety, nausea and vomiting will be evaluated. Satisfaction of patients, volunteers and nurses will also be measured to determine whether the program can be implemented and developed effectively. 53
  • 66. It is hoped that this massage program can be realized and implemented in the target clinical setting in the future. If so, this program should lead to a significant improvement in relieving anxiety for cancer patients receiving chemotherapy. Ultimately, this can result in a better quality of life for cancer patients in Hong Kong. 54
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  • 76. Appendix A: Search history Database 1: Medline (OvidSP) (1946 to July Week 3 2012) Date of search: 29th July 2012 Search keywords 1. Cancer.mp. or Neoplasms/ 2. Oncology.mp. 3. Carcinoma.mp . 4. Malignancy.mp. Results 893322 50794 535241 77770 5. 6. 7. Chemotherapy.mp. Massage.mp. Complementary therapies.mp. or Complementary Therapies 258505 9816 13047 8. 9. 10. 11. 12. 13. 14. Alternative therapies.mp . Alternative medicine.mp. Anxiety/ or Anxiety Disorders/ or anxiety.mp. Psychological discomfort.mp. Relaxation.mp. Mood disturbance.mp. Anticipatory nausea.mp. 2579 4871 125830 148 77684 888 170 15. 16. 17. 18. 19. Anticipatory vomiting.mp. 1 or 2 or 3 or 4 6 or 7 or 8 or 9 10 or 11 or 12 or 13 or 14 or 15 16 and 5 and 17 and 18 29 1467032 24872 214267 49 Results Total journals yielded= 49 Limited electronically to English, Full text & RCT= 13 Manual screened under inclusion and exclusion criteria= 8 64
  • 77. Database 2: CINAHL PLUS (EBSCOHost) (1967 to 2012) Date of search: 29th July 2012 Search ID # Search Terms Results S1 S2 S3 S4 S5 Cancer Neoplasms Oncology Carcinoma Malignancy 27396 33609 4411 5225 958 S6 S7 S8 Chemotherapy Massage Complementary therapies 4320 731 316 S9 S10 S11 S12 S13 S14 S15 Alternative therapies Alternative medicine Anxiety Anxiety disorders Psychological discomfort Relaxation Mood disturbance 3953 921 9437 2029 17 1331 101 S16 S17 S18 S19 S20 S21 S22 Anticipatory nausea Anticipatory vomiting S16 or S17 S1 or S2 or S3 or S4 or S5 S7 or S8 or S9 or S10 S11 or S12 or S13 or S14 or S15 or S18 S19 and S6 and S20 and S21 12 11 14 45559 4741 12701 14 Results Total journals yielded= 14 Limited electronically to English, Full text, RCT = 10 Manual screened under inclusion and exclusion criteria= 1 Discarded duplicated studies= 0 65
  • 78. Database 3: British Nursing Index (ProQuest) Date of search: 30th August, 2012 Set Search Results S1 S2 S3 S4 S5 Cancer Neoplasms Oncology Carcinoma Malignancy 12441 11 3153 148 104 S6 S7 S8 Chemotherapy Massage Complementary therapies 1332 436 1536 S9 S10 S11 S12 S13 S14 S15 Alternative therapies Alternative medicine Anxiety Anxiety disorders Psychological discomfort Relaxation Mood disturbance 2788 1092 1925 512 8 282 24 S16 S17 S18 S19 S20 S21 S22 Anticipatory nausea Anticipatory vomiting 16 or 17 1 or 2 or 3 or 4 or 5 S7 or S8 or S9 or S10 S11 or S12 or S13 or S14 or S15 or S18 S19 and S6 and S20 and S21 9 5 9 12627 2437 2649 13 Results Total journals yielded= 13 Manual screened under inclusion and exclusion criteria= 1 Discarded duplicated studies= 0 66
  • 79. Database 4: The Cochrane Library (ProQuest) Date of search: 30th August, 2012 ID #1 #2 #3 #4 #5 #6 Search (Cancer): ti,ab,kw (Neoplasms): ti,ab,kw (Oncology): ti,ab,kw (Carcinoma): ti,ab,kw (Malignancy): ti,ab,kw (Chemotherapy): ti,ab,kw Hits 5732 38865 813 8898 26 13891 #7 #8 #9 (Massage): ti,ab,kw (Complementary therapies): ti,ab,kw (Alternative therapies): ti,ab,kw 909 359 63 #10 #11 #12 #13 #14 #15 #16 (Alternative medicine): ti,ab,kw (Anxiety) : ti,ab,kw (Anxiety disorders): ti,ab,kw (Psychological discomfort): ti,ab,kw (Relaxation): ti,ab,kw (Mood disturbance): ti,ab,kw (Anticipatory nausea): ti,ab,kw 78 9584 3588 0 2289 2 121 #17 #18 #19 #20 #21 #22 (Anticipatory vomiting): ti,ab,kw (#16 OR #17) (#1 OR #2 OR #3 OR #4 OR #5) (#7 OR #8 OR #9 OR #10) (#11 OR #12 OR #13 OR #14 OR #15 OR #18) (#6 AND #19 AND #20 AND #21) 138 187 68502 1112 19434 54 Results Total journals yielded= 54 Limited electronically to English, Full text & RCT= 20 Manual screened under inclusion and exclusion criteria= 4 Discarded duplicated studies= 0 67
  • 80. Database 5: The PsycINFO database (1800s to 2012) Date of search: 3rd August, 2012 Set Search Results S1 S2 S3 S4 S5 Cancer Neoplasms Oncology Carcinoma Malignancy 46704 27785 10658 1051 1108 S6 S7 S8 Chemotherapy Massage Complementary therapies 3418 1010 2681 S9 S10 S11 S12 S13 S14 S15 Alternative therapies Alternative medicine Anxiety Anxiety disorders Psychological discomfort Relaxation Mood disturbance 11995 10578 157408 88889 1798 13090 3741 S16 S17 S18 S19 S20 S21 S22 Anticipatory nausea Anticipatory vomiting 16 or 17 1 or 2 or 3 or 4 or 5 S7 or S8 or S9 or S10 S11 or S12 or S13 or S14 or S15 or S18 S19 and S6 and S20 and S21 137 108 145 52757 21200 179486 33 Results Total journals yielded= 33 Limited electronically to English and adulthood (18 Yrs & Older) = 20 Manual screened under inclusion and exclusion criteria= 3 Discarded duplicated studies= 1 68
  • 81. Appendix B: Summary of search results Medline British The The PLUS Nursing Cochrane PsycINFO Index Electronic search by CINAHL Library database 49 14 13 54 33 13 10 1 20 20 8 1 0 4 3 Discarded duplicated studies 8 0 0 0 1 RCTs identified 8 0 0 0 1 keywords Limited electronically to English, adulthood and RCT Manual screened under inclusion and exclusion criteria 69
  • 82. Appendix C: List of selected studies 1. Ahles, T. A., Tope, D. M., Pinkson, B., Walch, S., Hann, D., Whedon, M., Dain, B., Weiss, J. E., Mills, L.& Silberfarb, P. M. (1999). Massage Therapy for Patients Undergoing Autologous Bone Marrow Transplantation. Journal of Pain and Symptom Management, 18(3), 157-163. 2. Billhult, A., Bergbon, I. & Stener-Victorin, S. (2007). Massage Relieves Nausea in Women with Breast Cancer Who Are Undergoing Chemotherapy. The Journal of Alternative and Complementary Medicine, 13(1), 53-57. 3. Billhult, A., Lindholm, C., Gunnarsson, R. & Stener-Victorin, E. (2008). The effect of massage in cellular immunity, endocrine and psychological factors in women with breast cancer- A randomized controlled clinical trial. Autonomic Neuroscience: Basic and Clinical, 140, 88-95. 4. Hernandez-Reif, M., Ironson, G., Field, T., Hurley, J., Katz, G., Diego, M., Weiss, S., Fletcher, M. A., Schanberg, S., Kuhn, C. & Burman, I. (2004). Breast cancer patients have improved immune and neuroendocrine functions following massage therapy. Journal of Psychosomatic Research, 57, 45-52. 5. Jane, S. W., Chen, S. L., Wilkie, D. J., Lin, Y. C., Foreman, S. W., Beaton, R. D., Fan, J. Y., Lu, M. Y., Wang, Y. Y., Lin, Y. H. & Liao, M. N. (2011). Effects of massage on pain, mood status, relaxation, and sleep in Taiwese patients with 70
  • 83. metastatic bone pain: A randomized clinical trial. The Journal of the International Association for the Study of Pain, 152, 2432-2442. 6. Listing, M., Krohn, M., Liezmann, C., Kim, I., Reisshauer, A., Peters, E., Klapp, B. F. & Rauchfuss, M. (2010). The efficacy of classical massage on stress perception and cortisol following primary treatment of breast cancer. Archives of Womens Mental Health, 13, 165-173. 7. Post-White, J., Kinney, M. E., Savik, K., Gau, J. B., Wilcox, C. & Lerner, I. (2003). Therapeutic Massage and Healing Touch Improve Symptoms in Cancer. Integrative Cancer Therapies, 2(4), 332-344. 8. Sharp, D. M., Walker, M. B., Chaturvedi, A., Upadhyay, S., Hamid, A., Walker, A. A., Bateman, J., Braid, F., Ellwood, K., Hebblewhite, C., Hope, T., Lines, M. & Walker, L. G. (2010). A randomized, controlled trial of the psychological effects of reflexology in early breast cancer. European Journal of Cancer, 46, 312-322. 9. Soden, K., Vincent, K., Craske, S., Lucas, C. & Ashley, S. (2004). A randomized controlled trial of aromatherapy massage in a hospice setting. Palliative Medicine, 18, 87-92. 71
  • 84. Appendix D: RCTs checklist CRITICAL APPRAISAL SKILLS PROGRAMME (CASP) Making sense of evidence 10 questions to help you make sense of a randomised controlled trial General comments  Three broad issues need to be considered when appraising research. A. Are the results of the study valid? B. What are the results? C. Will the results help locally? The questions on the following pages are designed to help you think about these issues systematically.  The first two questions are screening questions and can be answered quickly. If the answer to both is "yes", it is worth proceeding with the remaining questions.  There is a degree of overlap between several of the questions.  You are asked to record a "yes", "no" or "can't tell" to most of the questions.  A number of italicised hints are given after each question. These are designed to remind you why the question is important.  These questions are adapted from: Guyatt GH, Sackett DL and Cook DJ. Users’ guide to the medical literature II. How to use an article about therapy or prevention. JAMA; 1993; 270(21): 2598-2601 and JAMA 1994; 271(1): 59-63 72
  • 85. A. Are the results of the study valid? Screening Questions 1. Did the study ask a clearly focused research question? Consider: if the research question in ‘focus’ in terms of : - The population studied - The intervention given - The outcomes considered 2. Was this a randomized controlled trial (RCT) and was that an appropriate design? Consider: - Why was this study was carried out as an RCT - If this was the right research approach for the question being asked Is it worth continuing? ------------------------------------------------------------------------------------------------------ Detailed questions 3. Did the reviewers try to identify all relevant studies? Consider: - How participants were allocated to intervention and control groups. Was the process truly random? - Whether the method of allocation was described. Was a method used to balance the randomization, e.g. stratification? - How the randomization schedule was generated and how a participant was allocated to a study group? - If the groups were well balanced. Are any differences between the groups at entry to the trial reported? - If there were differences reported that might have explained any outcome(s) (confounding) 4. Were the participants, staff and study personnel ‘blind’ to participants’ study group? Consider: - The fact that blinding is not always possible - If every effort was made to achieve blinding 73
  • 86. - If you think it matters in this study - The fact that we are looking for ‘observer bias’ 5. Were all of the participants who entered the trial accounted for at its conclusion? Consider: - If any intervention-group participants got a control-group option or vice versa? If all participants were followed up in each study group (was there loss-to-follow-up)? If all the participants’ outcomes were analysed by the groups to which they were originally allocated (intention to treat analysis) What additional information would you like to have seen to make you feel better about this? 6. Were the participants in all groups followed up and data collected in the same way? Consider: - If, for example, they were reviewed at the same time intervals and if they received the same amount of attention from researchers and health workers. Any differences may introduce performance bias. 7. Did the study have enough participants to minimise the play of chance? Consider: - Is there a power calculation. This will estimate how many participants are needed to be reasonably sure of finding something important (if it really exists and for a given level of uncertainty about the final result) B. What are the results? 74
  • 87. 8. How are the results presented and what is the main result? Consider: - - 9 If, for example, the results are presented as a proportion of people experiencing an outcome such as ‘risk’ or as a measurement such as mean or median differences, or as survival curves and hazards. The magnitude of the results and how meaningful they are. How you would sum up the ‘bottom-line’ result of the trial in one sentence? How precise are the results? Consider: - If the result is precise enough to make a decision - If a confidence interval was reported. Would your decision about the effectiveness of this intervention be the same at the upper confidence limit as the lower confidence limit? - If a p-value is reported where confidence intervals are unavailable? C. Will the results help locally? 10. Were all the important outcomes considered so the results can be applied? Consider whether: - The people included in the trial could be different from your population in ways that might produce different results - Your local setting differs from that of the trial - You can provide the same treatment in your setting Consider outcomes from the point of view of the: - Individual - Policy maker and professionals - Family/carers - Wider community Consider whether: - Any benefit reported outweighs any harm and/or cost. If this information is not reported, can it be filled in from elsewhere - Policy or practice should change as a result of the evidence contained in this trial. -----------------------------------------------------------------------------------------------------75
  • 88. Appendix E: Level of evidence SIGN grading system: Level of evidence (Scottish Intercollegiate Guidelines Network, 2008) 1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias 1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias 2++ High quality systematic reviews of case control or cohort or studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3 Non-analytic studies, e.g. case reports, case series 4 Expert opinion Scottish Intercollegiate Guidelines Network. (2008). Key to evidence statements and grades of recommendations. Retrieved 30th August, 2012, from http://www.sign.ac.uk/guidelines/fulltext/50/annexb.html 76
  • 89. Appendix F: Quality assessment 1) Bibliographic citation: Ahles, et al., 1999 RCT 1. Did the study ask a clearly-focused question? Yes 2. Was this a randomized controlled trial (RCT)? Yes 3. Were participants appropriately allocation to intervention and Yes. But the randomization method was not described. There was no significant control groups? difference between groups. 4. Were participants, staff and study personnel ‘blind’ to participants’ study group? No. Blinding was impossible to the study participants. 5. Were all of the participants who entered the trial accounted for at its conclusion? Yes. Dropout rate was 2.9%. All participants were included in the intent-to-treat analysis. 6. Were the participants in all groups Yes. Same measurement tools were used to followed up and data collected in the same way? collect data for all groups. 7. Did the study have enough participants to minimize the play of chance? Can’t tell. The study did not set minimum sample size to achieve certain statistical power. The number of patients was n=16 & 18 each group. 8. How are the results presented, and what is the main result? State-Trait Anxiety Inventory-state (STAI-s) (Higher the score, higher level of anxiety.) Anxiety level decrease after first and fifth massage. 9. How precise are these results? Mean change and P value were showed. 10. Were all important outcomes considered so the results can be applied? Yes. The result can be applied as the studies and target population were the same. Level of evidence 1+ 77
  • 90. 2) Bibliographic citation: Billhult, et al., 2007 1. Did the study ask a clearly-focused question? Yes 2. Was this a randomized controlled trial (RCT)? Yes 3. Were participants appropriately allocation to intervention and control groups? Yes. Randomization was adopted using sealed opaque envelops. There was no significant difference between groups in demographic and clinical variables. 4. Were participants, staff and study personnel ‘blind’ to participants’ study group? No. Blinding was impossible to the study participants. 5. Were all of the participants who entered the trial accounted for at its conclusion? Yes. All patients were involved and provided data throughout the study period. 6. Were the participants in all groups followed up and data collected in the same way? Yes Same measurement tools were used to collect data for all groups. 7. Did the study have enough participants to minimize the play of chance? Can’t tell. The study did not set minimum sample size to achieve certain statistical power. The number of patients was n=19 & 20 each group. 8. How are the results presented, and what is the main result? HADS; VAS-nausea (Higher the score, higher the sense of nausea.) no statistically difference between groups in HADS. Massage group statistically reduced sense of nausea than control group. 9. How precise are these results? Mean change, SD, percentage change and P value were showed. 10. Were all important outcomes considered so the results can be applied? Yes. The result can be applied as the studies and target population were the same. Level of evidence 1+ 78 RCT
  • 91. 3) Bibliographic citation: Billhult, et al., 2008 1. Did the study ask a clearly-focused question? Yes 2. Was this a randomized controlled trial (RCT)? Yes 3. Were participants appropriately allocation to intervention and control groups? Yes. Randomization was adopted using sealed opaque envelops. There was no significant difference between groups in demographic characteristics. 4. Were participants, staff and study personnel ‘blind’ to participants’ study group? No. Blinding was impossible to the study participants. 5. Were all of the participants who entered the trial accounted for at its conclusion? Yes. All participants were involved and provided data throughout the study period. 6. Were the participants in all groups followed up and data collected in the same way? Yes Same measurement tools were used to collect data for all groups. 7. Did the study have enough participants to minimize the play of chance? Yes. The number of participants was enough to achieve a power of 80%. However, the number of patients was small (n=11/group). 8. How are the results presented, and what is the main result? Number of cells in blood specimen; HADS; STAI-s. No significant change of number of cells, anxiety and depression identified between groups. 9. How precise are these results? Median, 25th-75th percentile and P value were showed. 10. Were all important outcomes considered so the results can be applied? Yes. The result can be applied as the studies and target population were the same. Level of evidence 1- 79 RCT
  • 92. 4) Bibliographic citation: Hernandez-Reif, et al., 2004 RCT 1. Did the study ask a clearly-focused question? Yes 2. Was this a randomized controlled trial (RCT)? Yes 3. Were participants appropriately allocation to intervention and control groups? Yes. Randomization was adopted using a flip of a coin. There was no difference between groups on stage of cancer, type of surgery, treatments received and demographic variables. 4. Were participants, staff and study personnel ‘blind’ to participants’ No. Blinding was impossible to the study participants. study group? 5. Were all of the participants who entered the trial accounted for at its conclusion? Yes. All participants followed up until the end of study. 6. Were the participants in all groups followed up and data Yes Same measurement tools were used to collect data for all groups. collected in the same way? 7. Did the study have enough participants to minimize the play of chance? Yes. The number of patients was enough (N=34) to have power of 80%. But the sample size was small (n=18 & 16 on massage and control group). 8. How are the results presented, and what is the main result? STAI-s (Higher the score, higher level of anxiety.) The anxiety level of massage group statistically lower than the control group. 9. How precise are these results? Mean, percentage change and P value were showed. 10. Were all important outcomes considered so the results can be applied? Yes. The result can be applied as the studies and target population were the same. Level of evidence 1++ 80
  • 93. 5) Bibliographic citation: Jane, et al., 2011 1. Did the study ask a clearly-focused question? Yes 2. Was this a randomized controlled trial (RCT)? Yes 3. Were participants appropriately allocation to intervention and control groups? Yes. Randomization was adopted using computerized minimization program. There was no significant difference between groups on demographic and medical characteristics. 4. Were participants, staff and study personnel ‘blind’ to participants’ study group? No. Blinding was impossible to the study participants. 5. Were all of the participants who entered the trial accounted for at its conclusion? Yes. Dropout rate was 6.9%. Reasons for the dropout rate were explained. All participants were included for the intent-to-treat analysis. 6. Were the participants in all groups followed up and data collected in the same way? Yes. Same measurement tools were used to collect data for all groups. 7. Did the study have enough participants to minimize the play of chance? Yes. The number of patients was enough (n=36/group) to have power of 95%. 8. How are the results presented, and what is the main result? Present pain intensity (PPI-VAS); Mood-VAS; Relaxation-VAS; Sleep-VAS (Higher the score, higher level of the outcome measures.) The level of pain, mood and relaxation reduced in massage group than in control group. 9. How precise are these results? Mean, SD, ES, P value and the graphic results of means scores for the outcome measures over time were showed. 10. Were all important outcomes considered so the results can be applied? Yes. The result can be applied as the studies and target population were the same. Level of evidence 1++ 81 RCT
  • 94. 6) Bibliographic citation: Listing, et al., 2010 RCT 1. Did the study ask a clearly-focused question? Yes 2. Was this a randomized controlled trial (RCT)? Yes 3. Were participants appropriately allocation to intervention and control groups? Yes. Randomization was adopted by a simple randomization list by a study nurse not involved in the conduction of the study. There was no significant difference between groups in socio-demographic and clinical variables. 4. Were participants, staff and study personnel ‘blind’ to participants’ No. Blinding was impossible to the study participants. study group? 5. Were all of the participants who entered the trial accounted for at its conclusion? Yes. Dropout rate was 14.7%. All participants were included for the intent-to-treat analysis. Difference of dropouts and completers was compared. 6. Were the participants in all groups followed up and data Yes. Same measurement tools were used to collect data for all groups. collected in the same way? 7. Did the study have enough participants to minimize the play of chance? Can’t tell. The study did not set minimum sample size to achieve certain statistical power. The number of patients was n= 17/group. 8. How are the results presented, and what is the main result? Berlin Mood Questionnaire (BMQ)- subscale anxious depression. The effect size (ES) of anxious depression in massage group statistically improved at the end of the 5 weeks intervention period. 9. How precise are these results? Mean, SD, 95% CI, ES and P value were showed. 10. Were all important outcomes considered so the results can be applied? Yes. The result can be applied as the studies and target population were the same. Level of evidence 1+ 82
  • 95. 7) Bibliographic citation: Post-White, et al., 2003 1. Did the study ask a clearly-focused question? Yes 2. Was this a randomized controlled trial (RCT)? Yes 3. Were participants appropriately allocation to intervention and control groups? Yes. Randomization was adopted. But the method of randomization was not mentioned. There was no significant difference between groups in demographic characteristics. 4. Were participants, staff and study personnel ‘blind’ to participants’ study group? No. Blinding was impossible to the study participants. 5. Were all of the participants who entered the trial accounted for at its conclusion? Yes. Dropout rate was 29%. All participants were included in the intent-to-treat analysis. The reasons for the dropout rate were discussed. 6. Were the participants in all groups followed up and data collected in the same way? Yes Same measurement tools were used to collect data for all groups. 7. Did the study have enough participants to minimize the play of chance? No. The number of patients was enough (>32/group) to have power of 80%. 8. How are the results presented, and what is the main result? Brief Profile of Mood States (POMS)-anxiety subscale. The mean change of anxiety level in massage group statistically greater than the control group. 9. How precise are these results? Mean, standard deviation (SD) and P value were showed. 10. Were all important outcomes considered so the results can be applied? Yes. The result can be applied as the studies and target population were the same. Level of evidence 1+ 83 RCT
  • 96. 8) Bibliographic citation: Sharp, et al., 2010 RCT 1. Did the study ask a clearly-focused question? Yes 2. Was this a randomized controlled trial (RCT)? Yes 3. Were participants appropriately allocation to intervention and control groups? Yes. Randomization was adopted using sealed opaque envelops. All groups did not differ significantly for any demographic, clinical or outcome variables. 4. Were participants, staff and study personnel ‘blind’ to participants’ study No. Blinding was impossible to the study participants. group? 5. Were all of the participants who entered the trial accounted for at its conclusion? Yes. Dropout rate was 9.3%. All participants were included in the intent-to-treat analysis. Reasons for the dropout rate were explained. 6. Were the participants in all groups followed up and data collected in the Yes. Same measurement tools were used for data collection in all groups. same way? 7. Did the study have enough participants to minimize the play of chance? Yes. The number of patients was enough (>60/group) to provide power of 95%. 8. How are the results presented, and what is the main result? HADS; Mood Rating Scale (MRS)-relaxation subscale. (Higher the score, higher level of anxiety, depression and relaxation.) MRS-relaxation score in both reflexology group and massage group was statistically higher than control group. 9. How precise are these results? Mean, 95% confidence intervals (CI) and P value were showed. 10. Were all important outcomes considered so the results can be applied? Yes. The population of studies’ patients and target patients were the same. Level of evidence 1++ 84
  • 97. 9) Bibliographic citation: Soden, et al., 2004 RCT 1. Did the study ask a clearly-focused question? Yes 2. Was this a randomized controlled trial (RCT)? Yes 3. Were participants appropriately allocation to intervention and control groups? Yes. Randomization was adopted using concealed numbered opaque envelopes. There were significant more women in the control group than intervention group. But their baseline assessment scores were not significant differences between groups. 4. Were participants, staff and study personnel ‘blind’ to No. blinding was impossible to the study participants. Researchers were blind to the participants’ study group? interventions. 5. Were all of the participants who entered the trial accounted for at its conclusion? Yes. Dropout rate was 14.3%. All participants were included in the intent-to-treat analysis. Reasons for the dropout rate were explained. 6. Were the participants in all groups followed up and data Yes. Same measurement tools were used to collect data for all groups. collected in the same way? 7. Did the study have enough participants to minimize the play of chance? No. The number of patients was small (total N=42) (<45) and the power of 80% did not reached. 8. How are the results presented, and what is the main result? The Hospital Anxiety and Depression Scale (HADS) (Higher the score, higher level of anxiety and depression) nd Depression score in HADS decreased after 2 and th 4 massage. 9. How precise are these results? Mean change, median change and P value were showed. 10. Were all important outcomes considered so the results can be applied? Yes. The result can be applied as the studies and target population were the same. Level of evidence 185
  • 98. Appendix G: Table of evidence 1 Study, Design, Evidenc No. of patients & Patients characteristic Interventions Compariso Length of n/control follow up Outcome measures Result/Effect size 1. Ahles, et al., 1999 N=34 Mean age (SD) =41(9.3) Mean changes after first massage: Diagnosed breast n=18 -First massage Dropout=1 - Fifth massage receive (mid-treatment usual care ) 1. State-Trait Anxiety Inventory-state (STAI-s) RCT n=16 Dropout =0 - 20 minutes - Swedish massage 1+ cancer, lymphoma and leukemia admitted for bone marrow transplant (BMT) requiring high dose chemotherapy Area: shoulders, neck, face and scalp - 3 massages per week - 3 weeks in the autologous -Final massage BMT (predischarge) program 2. Beck Depression Inventory (BDI) Fatigue scale: -1.94 (P=0.02) Nausea scale: -1.94 (P=0.01) Mean changes after fifth massage (mid-treatment): 3. Brief Profile of Mood States (POMS) 1. STAI-state: -7.94 (P=0.02) 2. NS 3: NS 4. NS 4. Numerical scales (0-10) of emotional distress, fatigue, nausea and pain Mean changes after last massage (predischarge): 1. NS 2. NS 3. NS 4. Fatigue scale: -1.71 (P=0.03) e level, Country USA Massager: trained healing-arts specialists 86 1. STAI-state: -13.57 (P≦0.0001) 2. NS 3. NS 4. Distress scale: -1.6 (P=0.002)
  • 99. Table of evidence 2 Study, Design, Evidence No. of patients & Patients level, Country characteristic 2. Billhult, et al., 2007 N=39 Mean age (SD)=51.8 (9.3) RCT 1+ Sweden Interventions Comparison/contr ol Length of follow Outcome up measures Result/Effect size n=19 Dropout=0 n=20 Dropout=0 -20 minutes -Sweden massage -Visited by a hospital staff for -VAS scores of nausea and anxiety before and immediate after each 1. Mean change of VAS nausea in massage group vs mean change in control group: 73.2% vs 49.5% (P=0.025) Women with breast cancer undergoing chemotherap y which would be given every 3 with soft strokes - Either foot/lower leg or hand/lower arm -A cold-press vegetable oil used -Total 5 massage given during 20 minutes with unstructured conversation about any subject, but did not receive massage weeks chemotherapy cycle 3 to 7 intervention 1. VAS of nausea and anxiety 2. The Hospital No statistically significant differences in Anxiety and anxiety between 2 groups. -HADS assessed Depression before the first scale (HADS) 2. No statistically differences between and the last groups in changed in HAD anxiety and intervention depression. Massager: nurses and nurse’s aids 87
  • 100. Table of evidence 3 Study, Design, Evidence No. of patients & Patients characteristic Interventions Comparison /control Length of follow up Outcome measures Result/Effect size N=22 Mean age (SD) =62.5 (7) n=11 Dropout=0 n=11 Dropout=0 -20 minutes visit by 1. Peripheral blood sample on the number of NK cell and T helper cell 1. No statistically differences on peripheral blood concentration of NK cell and T helper cell between groups -20 minutes effleurage -Blood samples taken before the first and last massage/control visit massage -either foot/lower leg or hand/lower arm -10 times during 3 to 4 hospital staff with unstructured conversatio n about any topic level, Country 3. Billhult, et al., 2008 Women with RCT 1- breast cancer undergoing radiation therapy Sweden Massager: trained registered nurses 2. No statistically differences on HADS 2. HADS -HADS and STAI taken prior the first and last massage/control visit weeks 88 between groups 3. STAI 3. No statistically differences on STAI between groups
  • 101. Table of evidence 4 Study, Design, Evidenc No. of patients & Patients characteristic Intervention s Comparison /control Length of follow up Outcome measures N=34 Mean age (SD)=53(10.4) n=18 Dropout=0 n=16 Dropout=0 -First day of massage 1. STAI 2. POMS -Swedish massage Receive standard -Last day of massage 3. Symptom Checklist-90-R medical care (pretest of outcome measures 3, 4, 5 were performed before the 1st day of (SCL-90-R) massage and posttest performed after last day of massage) 5. Serum level of natural killer (NK) cell and lymphocytes Result (Pre/post % change in intervention vs control) e level, Country 4. Hernand ez-Reif, et al., 2004 RCT 1++ USA Women with stage 1 or 2 breast cancer after surgery Massager: trained massage therapist -head/neck, shoulder, back, arms and legs/feet -30 minutes -3 times per week -5 weeks 4. Urinary biochemistry on dopamine and serotonin 89 1. Significant improvement in STAI at the first and the last day of massage. First day : ↓ 27% vs ↓6% (P<0.01) Last day: ↓ 29% vs ↓6% (P<0.01) 2. Significantly decrease at the first day of massage: POMS-Depression: ↓75% vs ↓25% (P<0.01) And POMS-Anger: ↓80% vs ↓17% (P<0.01) % change from means difference of first-last day measures in intervention group for the longer term effect: 3. Depression ↓46% (P<0.05), Hostility ↓50% (P<0.05) 4. Urine level of dopamine: ↑26% (P<0.05), serotonin ↑60% (P<0.05) 5. Serum NK cells↑12% (P<0.05), lymphocytes ↑10% (P<0.05)
  • 102. Table of evidence 5 Study, Design, Evidence No. of patients & Patients level, Country characteristic 5. Jane, et al., 2011 N= 72 Mean age (SD) = 50 (10.6) Female: 58% RCT 1++ Taiwan Cancer patients who were able to speak and read Chinese with bone metastases Interventions Comparison /control Length of follow up Outcome measures Effect size between massage group and control group n= 36 Dropout= 2 n= 36 Dropout= 3 -Baseline assessment on Day 1 (T0) All outcome measures showed significant improvement at measurement time points T1, T2 and T3. -45 minutes full body -Presence of a caring -Pre & posttest 2. Mood-VAS massage -3 consecutive sessions therapist for 45 minutes (social attention) 3. Relaxation-VAS 1. Present pain intensity (PPI-VAS) 1. PPI-VAS: ES > 0.69 (P= 0.01) taken on Day 2 (T1), Day 3 (T2) and Day 4 (T3) 2. Mood-VAS: ES > 0.49 (P < 0.04) 3. Relaxation-VAS: ES > 0.45 (P < 0.03) -Last measures on Relaxation-VAS & Sleep-VAS done on Day 5 (T4) Massager: nurses 90
  • 103. Table of evidence 6 Study, Design, Evidence No. of patients & Patients characteristic Interventions Comparison /control Length of follow up Outcome measures Result/Effect size N=34 Mean age(SD)= 59.7(11.8) n=17 Dropout=1 -Biweekly -30 minutes Swedish n=17 Dropout=4 T1: baseline 1. Perceived Stress Questionnaire (PSQ) T2: at the end of the 5 2. Berlin Mood week Questionnaire (BMQ) 1. PSQ-worries decreased significantly in intervention group from 37.5 (T1)to 31.3(T2) (P=0.047) and remain low 28.3(T3) (P=0.003) 2. At T2, BMQ-Anger Effect size(ES) =0.82 (P<0.05) intervention At T2, BMQ-anxious depression ES=0.90 (P<0.05) At T3, BMQ-Tiredness mean difference between massage and control group= -15.73 (P<0.05) level, Country 6. Listing, et al., 2010 RCT Women with 1+ primary breast cancer Germany Massager: licensed, trained female massage therapist massage to the back, neck and head -5 weeks Routine health care T3: 6 weeks after T2 3. Serum cortisol and serotonin measure 3. Serum cortisol level decreased significantly at T2 (P=0.03). NS in serum serotonin level. 91
  • 104. Table of evidence 7 Study, Design, Evidence No. of patients & Patients Interventions Compariso Length of follow Outcome n/control up measures Result/Effect size level, Country characteris tic 7. Post-White, et al., 2003 N=230 Mean age (SD) = 54.7(11.7) -4 weekly -45 minutes A: Therapeutic massage (MT) n=78 Standard care 1. Heart rate, respiratory rate and blood pressure 1. MT and HT reduced respiratory rate (P<0.001), heart rate (P<0.001) and systolic (P<0.001) and diastolic pressure (P<0.001) 2. MT (P<0.001) and HT (P<0.011) have significantly lower in pain level. There is no Female: 86.1% Adult out-patient s receiving chemother apy -Swedish massage interventio intervention. on whole body n groups) - Outcome with massage gel measures 3, 4, 5 B: Healing touch measures before (HT) session 1 and n=77 each 4-week C: Caring crossover period 2. 0-10 scale of current pain and current nausea significantly different in nausea scale in MT and HT. 3. NS 4. NS Mean of MT at session 1→4 vs control at session 1→4: Massager: Registered nurses presence (P) n=75 4. Brief Nausea Index (BNI) RCT (crossover) 1+ USA (crossover from - Outcome measures 1& 2 were measure before and after each session 4, 5, 8. 3. Brief Pain Index (BPI) 5. POMS 92 5. POMS-Mood disturbance: 32.9→17.8 vs 31.0→29.6 (P=0.004) POMS-Anxiety: 11.1→7.6 vs 10.8→9.6 (P=0.02) HT reduced total mood disturbance (P=0.003) and fatigue (P=0.028) Presence had no different than control in POMS measures.
  • 105. Table of evidence 8 Study, Design, Evidenc No. of patients & Patients e level, Country characteristi c 8. Sharp, et al., 2010 N=183 RCT 1++ UK Interventions Compari Length of son/contr follow up ol Outcome measures Result/Effect size Mean age (SD)= 58.78 Intervention A: n=60 Dropout=3 reflexology on foot plus Intervent ion C: n=62 dropout= 11 - Primary end-point: 18 weeks after surgery (4 week after 1st outcome: 1. The Trial Outcome Index (TOI): composed of the sum of scores on the Means difference at primary end-point: 1. Intervention B has significant improvement on TOI: 4.01 (P=0.03) (10.31) Breast cancer female 6 weeks post breast surgery usual care Intervention B: n=61 Dropout=3 Scalp massage plus usual care Usual care last massage) physical, functional and breast cancer concern subscales. nd 2 outcome: 2. Mood Rating Scale (MRS) 3. HADS Intervention A-C: 26.92 (P≦0.0005) Intervention B-C: 26.21 (P≦0.0005) Intervention B has significant improvement in MRS-easy goingness: Intervention B-control: 24.8 (P≦0.0005) 3. NS Means difference at secondary end-point: Secondary end-point: 24 weeks after surgery (10 week after last massage) Massager: not mention 2. Both intervention A and B have significant improvement in MRS-relaxation: 1. 2. -1 hour session - Weekly -8 weeks Intervention A has significant improvement on TOI: 5.4 (P=0.02) Intervention A has significant improvement on MRS-relaxation: 18.23 (P=0.02) NS 3. 93
  • 106. Table of evidence 9 Study, Design, Evidence No. of patients & Patients level, Country characteristic 9. Soden, et al., 2004 RCT 1- Interventions Comparison / control Length of follow up Outcome measures Result/ Effect size N=42 Aged:44-85 years Median: 73 years - Usual care N=13 Weekly after every massage 1st outcome: 1. Visual Analogue Scale (VAS) of pain intensity 1. Statistically improvement on the mean change in pain VAS scores compared with baseline in second massage: AT: -1.15 (P=0.01) Female: 76% Dropout: 6 Aromatherapy massage group: (AT) n= during the 16 massage study period with lavender essential oil Massage group: (MT) UK All kind of cancer diagnosis Metastatic disease: 55% Massager: not mentioned - 30 minutes Back massage Weekly 4 week Did not receive any 2nd outcome: 2. HADS 2. MT have significant improvement on median HAD scores in second and fourth treatments: 2nd week: -2.0 (P≦0.05) 4th week: -1.5 (P≦0.01) n= 13 massage with inert carrier oil Massager: not mentioned. 94
  • 107. Appendix H: Table of summary for the studies’ results Citations 1999 Participants evidence 1. Ahles, et al., Level of Mean age Area of massage (Sample size) (SD) 1+ BMT 41 Swedish on USA N=34 (9.3) Duration shoulders, neck, face Frequency Massager Follow-up Outcome measures 20 min 3/week, Trained healing arts 3 wks specialists 1st, 5th & final STAI-s al., 2007 1+ Breast cancer 51.8 Swedish on either Sweden female on after 1 and 5 chemo 20 min Q3wks, Nurses 4. Hernandez, et al., 2004 Improve in Anxiety and VAS-nausea Nausea-VAS and after last massage 1- Breast cancer 62.5 Swedish on either Sweden female in RT foot/lower leg or during 3-4 N=22 al., 2008 HADS HADS: before the 1st hand/lower arm VAS: Before and after each massage on cycle 3-7 N=39 3. Bullhult, et th massage foot/lower leg or (9.3) Improve STAI-s st massage and scalp 2. Billhult, et Results hand/lower arm wks 1++ Breast cancer 53 Swedish on head/ USA female neck, shoulder, back, N=34 (7) (10.4) 20 min 30 min 10 time Nurses Before the 1st and after HADS No significant the last massage STAI improvement STAI-s Improve STAI-s in 3/week, Trained massage 1st and last day of 5 wks therapists massage arms, leg/feet 95 both follow up
  • 108. Citations 2011 Participants evidence 5. Jane, et al., Level of Mean age Area of massage (Sample size) (SD) 1++ Cancer patient 50 Swedish on whole Taiwan with bone met (10.6) Duration body Frequency Massager al., 2010 45min Baseline: day 1 session Mood-VAS: Day 2, 3, 4 VAS-Relaxation relaxation on day 2, Relaxation-VAS: Day 5 1+ Breast cancer 59.7 Swedish on back, Germany female neck and hand (11.8) 30 min Chemo pt 54.7 Swedish et al., 2003 USA N=230 (11.7) 8. Sharp, et al., 1++ Breast cancer 58.78 Scalp UK female 3, 4. Biweekly, Licensed trained Baseline, at the end BMQ-anxious Improve BMQ- massage therapists and 6 wk after final depression anxious depression at on whole 45 min Weekly, Nurses the end of massage (10.31) Weekly, 8 wks subscale anxiety 4 week and 10 week HADS Improve MRS- after last massage Not mentioned Improve POMS- MRS-relaxation relaxation score after subscale 1 hr POMS-anxiety 4th massage 4 wks Before 1st and after 4 weeks HADS Improve in N=183 2004 Improve mood and 5 wks body 9. Soden, et al., VAS-Mood massage 1+ 2010 Results 3 consecutive Nurses N=34 7. Post-White, Outcome measures N=72 6. Listing, et Follow-up 1- All cancer Median: UK N=42 73 Back 30 min Weekly, 4 wks Not mentioned Weekly HADS-depression on nd th 2 & 4 week 96
  • 109. Appendix I: Estimated expenses that can be saved by reducing use of potent anti-emetics Choice of potent anti-emetics: Anti-emetics Dosage Frequency #Cost for 1 day Duration Cost for 3 days per patient Navoban 5mg Daily $63.5 3 days $63.5 x3 = $190.5 Kytril 1mg Twice a $71.4 x2 3 days $142.8 x3 = $428.4 day = $142.8 Twice a $20 x2 3 days $40 x3 = $120 day = $40 Zofran 8mg # the price of medication is based on the Drug formulary at the Hospital Authority. The average costs of taking these drugs for 3 days per patient: ($190.5+$428.4+$120)/3 = $246.3 Assuming 20% of total patients (233 patients) joining the program per year do not require the use of these potent anti-emetics after receiving massage, The estimated costs saved: $246.3 x233 ~ $57,000 97
  • 110. Appendix J Budget plan for implementing the massage program Budget Plan Estimated Cost Training -Venue for holding the briefing session $0 -Printing notes for the training: RNs x15 $5/ person x25 = Volunteers x10 $125 -Computer and projector device $0 Total estimated expense for training: $125 Running cost Printed materials:  Posters and leaflet  Consent  Self-design nurse assessment checklist -Massage oil (lubricant) $5/ person $5/ person Estimated expenses for running the program $10/person per patient: Estimated expenses for the program per year: Total patients admitted to the day ward in the past year 11,692 Assuming half of the total patients experience anxious: If 20% of the anxious patients are eligible and willing to join the program: Estimated expenses for running the program for a year: 11,692 / 2 5,846 5,846 x 20% 1,169 $125 + ($10 x 1,169) ~ $12,000 98
  • 111. Appendix K: Grade of recommendation SIGN grading system: Grade of Recommendation (Scottish Intercollegiate Guidelines Network, 2008) A At least one meta analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or A systematic review of RCTs or a body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results. B A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ D (GPP) Recommended best practice based on the clinical experience of the guideline development group GPP: Good practice points Scottish Intercollegiate Guidelines Network. (2008). Key to evidence statements and grades of recommendations. Retrieved 30th August, 2012, from http://www.sign.ac.uk/guidelines/fulltext/50/annexb.html 99
  • 112. Appendix L Evidence-based practice guideline of massage for cancer patients receiving chemotherapy Introduction Cancer patients receiving chemotherapy experience various treatment-related side effects including nausea, anxiety, impairing their quality of life. A study (Molassiotis, et al., 2002) showed that there were 15-40% cancer patients suffering from psychological disorders related to anxiety and depression during chemotherapy. The use of massage for cancer patients receiving chemotherapy can greatly improve their anxiety, mood status and severity of nausea and vomiting, hence, improving their quality of life (Corbin, 2005). The following evidence-based practice (EBP) guideline is developed for the use of massage on adult cancer patients receiving chemotherapy to reduce anxiety in the chemotherapy day ward. This EBP guideline is developed based on the evidence generated from nine RCTs. The recommendation and the level of evidence are graded according to the Scottish Intercollegiate Guideline Network (SIGN, 2008). Aim The aim of this guideline is to implement feasible and effective massage interventions to reduce anxiety for cancer patient receiving chemotherapy in an outpatient clinic setting. Objectives To provide a consistent framework for implementation of safe and effective massage therapy to cancer patients to reduce their anxiety from receiving chemotherapy. 100
  • 113. Target population The massage therapy is applicable to both male and female adult cancer patients who are receiving chemotherapy in the chemotherapy day ward. Inclusive criteria - Aged 18 or above - Cantonese- and Mandarin-speaking patients who are able to read Chinese. - Cognitively competent Exclusive criteria - Coagulation disorder - Spinal cord injury - Venous thrombosis - Bone metastasis - Peripheral neuropathy - Radiation dermatitis - Open wound over lower limbs (Recommendation 1.0) Roles and responsibilities of nurses 1. Introduce and explain the massage program to potential patients and give a pamphlet on the massage therapy to them. 2. Seek oncologist’s approval for the selected patient to receive massage therapy during patient’s second chemotherapy follow-up by asking oncologist to sign on the assessment form attached on patients’ medical record. 3. Reconfirm eligibility of patient during the next admission to day ward for chemotherapy and obtain a written consent. 101
  • 114. 4. Ask patient to complete the State-Trait Anxiety Inventory (STAI) assessment form on admission and after receiving the massage to measure patient’s level of anxiety. (Recommendation 4.0) 5. Check patient’s vital signs including blood pressure, pulse, respiratory rate and oxygen saturation and document in the assessment form before and after the massage intervention. 6. Refer appropriate patient to the massagist for therapy. 7. Educate patient to report any discomfort or abnormalities when receiving massage therapy. 8. Observe patient’s response to the therapy for at least 5 minutes after commencement for the first treatment and as necessary. 9. Monitor and manage patients with massage-induced complications (see Table 1). 10. Refer patients to oncologist for subsequent treatment if necessary. The massage protocol 1. 30 minutes Swedish massage is recommended to perform on patient’s lower limbs every 3 weeks. (Recommendations 2.0 and 3.0) 2. Maximum 5 sessions will be given to cancer patients or until patient’s chemotherapy treatment completed. 3. Step of massage (Table 2.): I. Strokes from the ventral side of the foot up around the knee and back to the foot. II. Small circular movements and kneading on the side of the calf from the foot to the knee. 102
  • 115. III. Circular stroking around the sides of the knee and the ankle. IV. Stroking on the ventral side of the foot. V. Strokes on the dorsal side of the foot. VI. Strokes from the ventral side of the foot up around the knee and back to the foot. VII. Repeat step I to VI on another leg. *The step of massage is based on the study (Billhult, et al., 2008). * 103
  • 116. Evidence of the recommendations Recommendation 1.0 Nursing assessment should be performed to exclude high risk patients from joining the massage program. (Grade of recommendation: A) Patients with medical conditions including coagulation disorder, spinal cord injury, thrombosis, bone metastasis, peripheral neuropathy, radiation dermatitis and open wound over lower limbs are excluded from receiving massage in four of the reviewed RCTs(Hernandez-Reif, et al., 2004; Jane, et al., 2011; Sharp, et al., 2010; Listing, et al., 2010). This is necessary as these conditions may heighten the risk of massage complications such as neuropathy damage, hematoma, bleeding and dislodging of deep venous thrombosis causing embolism (Hernandez-Reif, et al, 2004; Jane, et al., 2011; Sharp, et al., 2010; Listing, et al., 2010) (1++; 1++; 1++; 1+). Recommendation 2.0 Swedish massage is recommended to perform on patient’s lower limbs. (Grade of recommendation: A) No complication such as fractures, dislocations, nerve damage and pulmonary embolism were reported from participants in seven reviewed RCTs which used Swedish massage as their interventions. (Ahles, et al., 1999; Billhult, et al., 2007; Billhult, et al., 2008; Hernandez-Reif, et al., 2004; Jane, et al., 2011; Listing, et al., 2010; Post-White, et al., 2003). (1+; 1+; 1-; 1++; 1++; 1+; 1+) 104
  • 117. Recommendation 3.0 The duration of massage therapy is recommended as 30 minutes. (Grade of recommendation: A) Six reviewed studies used 20-30 minute massage and five of them reported to have positive effects in reducing level of anxiety and sense of nausea for cancer patients (Ahles, et al., Billhult, et al., 2007; Billhult, et al., 2008; Hernandez-Reif, et al., 2004; Listing, et al., 2010; Soden, et al., 2004). The immediate short-term (30 min) benefits of massage therapy is well proved to reduce anxiety for cancer patients (Hernandez-Reif, et al., 2004; Listing, et al., 2010; Soden et al., 2004). (1++; 1+; 1- ) Recommendation 4.0 The State-Trait Anxiety Inventory (STAI-S) measuring tool should be used to measure the patient’s level of anxiety before and after the massage so as to evaluate the effectiveness of this massage program. (Grade of recommendation: A) Five reviewed RCTs used one-dimensional self assessment tools to measure the subjective feeling of anxiety for cancer patients (Ahles, et al., 1999; Billhult, et al., 2007; Bullhult, et al., 2008; Hernandez-Reif, et al., 2004; Jane, et al., 2011). Three of them used STAI-S assessment tool to measure anxiety level for cancer patients and resulted in decrease in their anxiety level (Ahles, et al., 1999; Billhult, et al., 2008; Hernandez-Reif, et al., 2004). STAI-S is a valid and reliable one-dimensional assessment tool that is short and easy for cancer patients to complete. (1+; 1-; 1++) 105
  • 118. Table 1. Potential massage-induced complications, manifestations and management Potential complications  Petechia  Bruise  Hematoma Patient Manifestation Management  Blue or purple discoloration on skin Dizziness Decrease in blood pressure Tachycardia     Stop the massage. Assess the possible cause of skin rash. Maintain a patent intravenous line. Inform doctor. Pain     Stop the massage. Assess the cause of pain. Immobilize the leg. Inform doctor if necessary. Shortness of breath Tachycardia Dramatically change in blood pressure  Stop the massage.  Lie down the patient.  Close monitor patient’s vital signs including blood pressure, pulse, oxygen saturation (SpO2), and temperature.  Maintain a patent intravenous line.  Provide oxygen therapy if necessary.  Provide basic life support.  Inform doctor.      Muscular  pain over the site where massage is applied Embolism    106
  • 119. Table 2. Step of massage Apply to left / right leg I. Strokes from the ventral side of the foot up around the knee and back to the foot. II. Small circular movements and kneading on the side of the calf from the foot to the knee. III. Circular stroking around the sides of the knee and the ankle. Stroking on the ventral side of the IV. Strokes on the ventral side of the foot. foot. V. Strokes on the dorsal side of the foot. VI. Strokes from the ventral side of the foot up around the knee and back to the foot. VII. Repeat step I to VI on another leg 107
  • 120. Reference of the guideline: 1. Ahles, T. A., Tope, D. M., Pinkson, B., Walch, S., Hann, D., Whedon, M., Dain, B., Weiss, J. E., Mills, L.& Silberfarb, P. M. (1999). Massage Therapy for Patients Undergoing Autologous Bone Marrow Transplantation. Journal of Pain and Symptom Management, 18(3), 157-163. 2. Billhult, A., Bergbon, I. & Stener-Victorin, S. (2007). Massage Relieves Nausea in Women with Breast Cancer Who Are Undergoing Chemotherapy. The Journal of Alternative and Complementary Medicine, 13(1), 53-57. 3. Billhult, A., Lindholm, C., Gunnarsson, R. & Stener-Victorin, E. (2008). The effect of massage in cellular immunity, endocrine and psychological factors in women with breast cancer- A randomized controlled clinical trial. Autonomic Neuroscience: Basic and Clinical, 140, 88-95. 4. Hernandez-Reif, M., Ironson, G., Field, T., Hurley, J., Katz, G., Diego, M., Weiss, S., Fletcher, M. A., Schanberg, S., Kuhn, C. & Burman, I. (2004). Breast cancer patients have improved immune and neuroendocrine functions following massage therapy. Journal of Psychosomatic Research, 57, 45-52. 5. Jane, S. W., Chen, S. L., Wilkie, D. J., Lin, Y. C., Foreman, S. W., Beaton, R. D., Fan, J. Y., Lu, M. Y., Wang, Y. Y., Lin, Y. H. & Liao, M. N. (2011). Effects of massage on pain, mood status, relaxation, and sleep in Taiwese patients with metastatic bone pain: A randomized clinical trial. The Journal of the International Association for the Study of Pain, 152, 2432-2442. 6. Listing, M., Krohn, M., Liezmann, C., Kim, I., Reisshauer, A., Peters, E., Klapp, B. F. & Rauchfuss, M. (2010). The efficacy of classical massage on stress perception and cortisol following primary treatment of breast cancer. Archives of Womens Mental Health, 13, 165-173. 108
  • 121. 7. Post-White, J., Kinney, M. E., Savik, K., Gau, J. B., Wilcox, C. & Lerner, I. (2003). Therapeutic Massage and Healing Touch Improve Symptoms in Cancer. Integrative Cancer Therapies, 2(4), 332-344. 8. Sharp, D. M., Walker, M. B., Chaturvedi, A., Upadhyay, S., Hamid, A., Walker, A. A., Bateman, J., Braid, F., Ellwood, K., Hebblewhite, C., Hope, T., Lines, M. & Walker, L. G. (2010). A randomized, controlled trial of the psychological effects of reflexology in early breast cancer. European Journal of Cancer, 46, 312-322. 9. Soden, K., Vincent, K., Craske, S., Lucas, C. & Ashley, S. (2004). A randomized controlled trial of aromatherapy massage in a hospice setting. Palliative Medicine, 18, 87-92. 109
  • 122. Appendix M: Timetable for implementation of the massage program Sep 2013 Oct 2013 Nov 2013 1. Forming a team of core members 2. Seeking administrator’s approval 3. Refining the guideline 4. Training to nurses and volunteers 5. Pilot study 6. Amending guideline and logistics of the program 7. Implementing the program 8. Evaluating the outcome 9. Generating report and disseminating the finding 110 Dec 2013 Jan 2014 to Jun 2014 Jul 2014 Aug 2014
  • 123. Appendix N Gum label Assessment form for the massage program Part 1 Patient Diagnosis: ________________ No. of massage sessions received: Name of chemotherapy received: No. of cycle of chemotherapy: Date of receiving massage: ********************************************************************* Part 2 Medical assessment (Completed by oncologists during patient’s follow-up) No Yes Remarks 1. Does the patient have coagulation disorder? 2. Does the patient have history of spinal cord injury? 3. Does the patient have history of thrombosis? 4. Does the patient have bone metastasis? 5. Does the patient experience chemotherapy-induced peripheral neuropathy? Can the patient receive massage therapy? No Yes No massage therapy is allowed if any “yes” on the above items. Doctor’s signature: Date: ********************************************************************* 111
  • 124. Assessment form for massage program Page. 2 ********************************************************** Part 3 Nursing integrated assessment (Complete by nurses on the same day of massage) 1. Is an informed consent being obtained? No Yes 2. Is the patient receiving concurrent chemotherapy and radiation? No Yes Lower limbs skin Assessment: 1. Skin integrity Wounded Intact 2. Skin color Pale Erythema Cyanotic Pink 3. Skin texture Dry Scaly Oily Normal Edema normal 4. Skin turgor Special Medication History: Use of opioids: No Yes Please specify type, dosage, frequency: Use of anxiolytics: No Yes Please specify type, dosage, frequency: Use of antiemetics: No Yes Please specify type, dosage, frequency: Blood Result: Platelet count: Clotting: Can the patient receive massage therapy? No Yes Pre-massage vital signs: BP: mmHg P: /min SpO2: % Post-massage vital signs: BP: mmHg P: /min SpO2: % Remarks: Nurse’s signature: Date: ******************************************************************* 112
  • 125. Assessment form for massage program Part 4 Page. 3 按摩前評估 Pre-massage measurement form(由病人填寫) (一) 情景特質焦慮量表-情境焦慮部分 (STAI-S) 以下是一般人常用來描述自己感受的句子,請仔細閱讀每一句,然後根據你現在的感受 (即此時 此刻的感受),圈選一個最適當的答案。 完 全 不 符 合 有 頗 極 些 為 為 符 符 符 合 合 合 1 我現在覺得心裡平靜 # 1 2 3 4 2 我現在覺得安全 # 1 2 3 4 3 我現在是緊繃的 1 2 3 4 4 我現在覺得很緊張 1 2 3 4 5 我現在覺得很放鬆 # 1 2 3 4 6 我感到困擾 1 2 3 4 7 我現在正擔心可能將有不幸的事會發生 1 2 3 4 8 我現在覺醒很滿意 # 1 2 3 4 9 我現在覺得害怕 1 2 3 4 10 我現在覺得心裡舒適 # 1 2 3 4 11 我覺得我是自信的 # 1 2 3 4 12 我覺得我很神經質 1 2 3 4 13 我常常是戰戰兢兢的 1 2 3 4 14 我覺得自己優柔寡斷 1 2 3 4 15 我現在是放鬆的 # 1 2 3 4 16 我現在覺得很滿足 # 1 2 3 4 17 我現在是憂慮的 1 2 3 4 18 我現在覺得困惑 1 2 3 4 19 我現在覺得穩定 # 1 2 3 4 20 我現在覺得很愉快 # 1 2 3 4 # 為反向計分 ******************************************************************** 113
  • 126. Assessment form for massage program Part 5 按摩後評估 Post-massage measurement form(由病人填寫) Page. 4 (一) 情景特質焦慮量表-情境焦慮部分 (STAI-S) 以下是一般人常用來描述自己感受的句子,請仔細閱讀每一句,然後根據你現在的感受 (即此時 此刻的感受),圈選一個最適當的答案。 完 全 不 符 合 有 頗 極 些 為 為 符 符 符 合 合 合 1 我現在覺得心裡平靜 # 1 2 3 4 2 我現在覺得安全 # 1 2 3 4 3 我現在是緊繃的 1 2 3 4 4 我現在覺得很緊張 1 2 3 4 5 我現在覺得很放鬆 # 1 2 3 4 6 我感到困擾 1 2 3 4 7 我現在正擔心可能將有不幸的事會發生 1 2 3 4 8 我現在覺醒很滿意 # 1 2 3 4 9 我現在覺得害怕 1 2 3 4 10 我現在覺得心裡舒適 # 1 2 3 4 11 我覺得我是自信的 # 1 2 3 4 12 我覺得我很神經質 1 2 3 4 13 我常常是戰戰兢兢的 1 2 3 4 14 我覺得自己優柔寡斷 1 2 3 4 15 我現在是放鬆的 # 1 2 3 4 16 我現在覺得很滿足 # 1 2 3 4 17 我現在是憂慮的 1 2 3 4 18 我現在覺得困惑 1 2 3 4 19 我現在覺得穩定 # 1 2 3 4 20 我現在覺得很愉快 # 1 2 3 4 # 為反向計分 ******************************************************************** 114
  • 127. Assessment form for massage program Part 5 按摩後評估 Post-massage measurement form(由病人填寫) (二) 噁心評估量表 Numerical Rating Scale (NRS-Nausea) 請以 0-10 分之分數,表達出你於按摩時的不同時間之噁心嚴重度。 (0 分為不噁心,10 分為非常噁心。) 按摩前 (0 分鐘): 開始按摩後 (15 分鐘): 開始按摩後 (30 分鐘): (三) 嘔吐評估量表 Numerical Rating Scale (NRS-Vomiting) 請以 0-10 分之分數,表達出你於按摩時的不同時間之嘔吐嚴重度。 (0 分為沒有嘔吐,10 分為嚴重嘔吐。) 按摩前 (0 分鐘): 開始按摩後 (15 分鐘): 開始按摩後 (30 分鐘): ~問卷完~ ~多謝參與~ 115 Page. 5

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