Effectiveness of Chemotherapy Counseling by Pharmacists

EFFECTIVENESS OF CHEMOTHERAPY
COUNSELING AMONG ONCOLOGY PATIENTS
ON NAUSEA AND VOMITING BY
PHARMACISTS IN A GOVERNMENT HOSPITAL
IN MALAYSIA-
A RANDOMISED CONTROLLED TRIAL
Name : Ummavathy Periasamy
Program :PHD in Community Health
Co- Authors :Professor Dr.Sherina Mohd Sidik
:Professor Dr. Lekhraj Rampal
:Dr. Siti Irma Fadhilah
1

TABLE OF CONTENT
• Introduction
• Significance of Study
• Study Justification
• Objectives
• Hypothesis
• Literature Review
• Materials and Methods
• Results
• Discussion
• Conclusion
• References
2

INTRODUCTION
• Cancer is a global public health concern.
According to the World Health Organization
(WHO, 2007), by 2020 cancer related deaths will
total above 11 million people worldwide,
including 4.7 million people from developed
countries and 5.5 million people from developing
countries (NCI, 2004).
• Cancer refers to the uncontrolled growth and
spread of cells. These cancer cells can reach
almost all parts of the body, and growths usually
invade surrounding tissues and may metastasize
to distant sites (National Cancer Institute, 2004)
3

• Cancer treatment can be done in four basic ways; through
local treatments of surgery and radiotherapy, or through
systemic treatments by using biological agents (for example
hormones, antibodies and growth factors) and
chemotherapy (NCI, 2008; NCI 2007).
• Chemotherapy, used alone or in combination with surgery
and or radiotherapy, plays a major role in the treatment of
cancer (NCI, 2008; NCI 2007).
• Counselling is designed to help cancer patients respond to
challenges, the associated emotions and provide a safe
environment for them to talk about their concerns (Forster,
et al., 2003)
• In Malaysia, cancer is now the fourth leading cause of
death among medically certified deaths and the estimated
annual incidence of cancer is 30,000. National Cancer
Registry estimate that 1 in 4 Malaysians may have cancer in
their lifetimes (Lim, 2006).
4

SIGNIFICANCE OF STUDY
• If this study is found to be effective, the present study
would benefit the patients and the pharmacists.
• The pharmacist would be able to use the module as a guide
during each counselling session with the oncology patients
for every cycle during the chemotherapy regime.
• The module will enable pharmacists to spend more quality
time with each patient receiving chemotherapy.
• Cancer patients would benefit by overcoming/reducing
side effects (nausea and vomiting) induced by
chemotherapy treatment and improve their quality of life.
5

STUDY JUSTIFICATION
If the module is found to be effective in this
study it can be implemented in other
hospitals.
6

OBJECTIVES
GENERAL OBJECTIVE:
•To develop, implement and evaluate the
chemotherapy counselling module by
pharmacists among oncology patients.
7

SPECIFIC OBJECTIVES:
1.To develop and implement a module on chemotherapy
counselling for cancer patients by pharmacists in
government hospitals in Malaysia.
2.To evaluate the effectiveness of the chemotherapy
counselling module in reducing chemotherapy induced
physical effects (nausea and vomiting).
3.To evaluate the effectiveness of repetitive
chemotherapy counseling in reducing chemotherapy
induced physical effects (nausea and vomiting) among
oncology patients receiving chemotherapy.
8

HYPOTHESIS
• H1: The chemotherapy module is effective in
reducing chemotherapy induced physical
effects (nausea and vomiting).
• H2: Repetitive chemotherapy counselling is
more effective than single counselling in
reducing chemotherapy induced physical
effects (nausea and vomiting).
9

LITREATURE REVIEW
• Cancer is the uncontrolled growth of abnormal cells in
the body (Moscow, et al., 2007).
• It requires continuous treatment and monitoring over
the long term. To avoid drug related problems, cancer
patients need advice on the appropriate self-care. This
will ensure the maximum benefit from treatment
(Possidente, et al., 2005).
• Patients require counselling to promote adherence, to
educate patients on the adequate dosage, frequency
of medication, what to do if dose is missed, timing of
food and medication and any actions that should be
taken in case of side effects (Brennan, 2004).
10

LITREATURE REVIEW
• Chemotherapy is commonly used to treat
cancer patients and reduce tumour relapse.
However, chemotherapy induced side effects
has been a major concern (Chabner, et al.,
2005)
• Physical Effects (Prevelence)
Nausea 90.9% (Piko, 2009 )
Vomiting 72.0% (Piko, 2009 )
11

METHODOLOGY
     Study Location
• The study was conducted at the day care unit and medical
wards Hospital Tuanku Jaafar, Seremban, Negeri Sembilan,
Malaysia.

     Study Design
• A randomized placebo controlled study design was used in
this study.

     Study Population
• Cancer patients (stage 1-4) aged 18 years old and above in
their first cycle and second cycle of chemotherapy treatment
at Hospital Tuanku Ja’afar Seremban.
12

SAMPLE SIZE CALCULATION
n2 = kn1
n1 =total number of sample in one group
Zα =data for alpha; p =0.05, therefore 95% confidence interval desired (2 tailed test) =
1.96
Zβ = data for beta; 10% beta error, therefore 90% power desired (one tailed test)=
1.28
p1 = the proportion of disease free survival with chemotherapy at 5 years = 69% =
0.69
(NCI, 2012)
p2 = The estimated proportion of disease free survival with chemotherapy at 5 years
after intervention with the module on ‘Managing Patients on Chemotherapy’ by
Pharmacists (estimated proportion of overall survival with chemotherapy at 5
years with intervention:20% difference of the two groups) = 89% = 0.89
(Rosner, 2006)
13

Zα=Z1–α/2 = 1.96
Zβ=Z1–β= 1.28 k = 1 (because n1=n2)
p1 = 0.69 p = (p1+ p2) / 2 = 0.79
q1 = 1- 0.69 = 0.31 q = 1 – 0.79 =0.21
p2 = 0.69 + 0.2 = 0.89 ∆ = p1–p2= 0.69 – 0.89 =
- 0.2
q2 = 1- 0.89 = 0.11
= 80.55 ~ 81 per group
= 81 x 2 =162
The minimum number of participants required in this study was 81 for
each group. Therefore, a total sample size of 162 for both
intervention and control groups was fixed with equal numbers in
each group.
(Rosner, 2006)
14

Figure 1: MODULE DEVELOPMENT
15
A Focus group Discussion (FGD) was conducted among 20 oncology patients at HTJS
Based on the information gathered from the FGD a preliminary chemotherapy counselling
module was developed. Some material was combined from the ‘Chemotherapy and You’
module developed by the National Cancer Institute.
A pilot test was conducted, among 40 oncology patients at HTAN. A baseline evaluation was done
on physical effects, psychological effects, self-esteem and quality of life. 20 patients were recruited
into the intervention group and another 20 were recruited into the control group.
Patients from the intervention group of the pilot test were followed up for the next
cycle and given counselling based on the preliminary module. The control group
continued receiving the current practice.
A second and third follow up was done consecutively and the outcome of the
repetitive chemotherapy counselling was evaluated.
This was followed by an evaluation among pharmacist at HTJS to determine the need and
also the information needed in the module guide. All feedback were noted.
All information collected were incorporated into the chemotherapy counselling module in consultation
with a panel of experts. The final version of the ‘Managing Patients on Chemotherapy’ by pharmacist
module was checked and rechecked to establish content validity

•INCLUSION CRITERIA
 Patients aged 18 years old and above with any type of cancer
and stage undergoing chemotherapy treatment at HTJS for their
first and second chemotherapy cycle.
The ability of the patients to communicate well during the
study and those who were Malaysian citizens.
•EXCLUSION CRITERIA
 Patients with severe communication problems such as speech
or hearing difficulties
Any suicidal, tendencies, or psychotic features.
16

Figure 2. STUDY POPULATION
17
• List of patients registered for chemotherapy was obtained. Explanation of the study being conducted was given
to the patients
• The consent was obtained
• Patient who met the inclusion and exclusion criteria were recruited into the study.
Randomization and Blinding
INTERVENTION GROUP
-Baseline evaluation was done using a set of validated
and pretested questionnaires (similar to the control
group)
-1st
counselling; was conducted after the baseline
evaluation, where patients were counselled using the
module on ‘Managing Patients on Chemotherapy’
-Patients were followed up according to their
appointment dates for their next chemotherapy cycles
-The same questionnaires were distributed again. This
was followed by the 2nd
counselling session.
The same step was repeated; where the same
questionnaires were administered and this was
followed by the 3rd
counselling session. Each time, the
evaluation was done first followed by repeated
counselling using the module as a guide.
CONTROL GROUP
-A baseline evaluation was done using a set of
validated and pretested questionnaires
- Patients were given basic explanation on
chemotherapy side-effects depending on the
pharmacist own knowledge.
-Patients were followed up according to their
appointment date.
-The same questionnaires were then distributed
again for their next chemotherapy cycle
-This step was repeated consecutively for the 2nd
and
3rd
evaluation. Throughout the evaluation no
counselling was done, unless there were any
questions asked which were addressed based on the
pharmacists’ knowledge.

VARIABLES
Independent variables
Intervention Module (those
receiving and not receiving
the module)
Dependent variables
Physical effects due to
chemotherapy;
(nausea; vomiting)
18

INSTRUMENT
19
QUESTIONNAIRE VALIDATED ADVERSE EVENT
National Cancer Institute
Common Toxicity Criteria
version 4.0,
National Cancer Institute
Common Terminology
Criteria for Adverse Events
v4.0
NCI, NIH, DHHS. May 29,
2009
Trotti, A., Byhardt, R.,
Stetz, J., Gwede, C.,
Karen, F.C.,
Gunderson,L.,
McCormick,B., Morris∫,
M., Rich, T., International
Journal of Radiation
Oncology*Biology*Physic
s. 47(1): 13-47
SCORE SEVERITY
0 NO
1 MILD
2 MODERATE
3 SEVERE
4 LIFE
TREATENING

Validity and Reliability
Instrument : Validity of Module and Questionnaire
Instrument : Reliability of Questionnaire
• Reliability of the questionnaire was measured by checking the internal consistency
using Cronbach’s Alpha and values above 0.7 were considered as acceptable and
shown in Table 1 below.
20
Instrument Number of items Cronbach’s Alpha
Physical effects * 2 0.70
*
*Physical effects: (nausea, vomiting)

ETHICS APPROVAL
• Medical Research Ethics Committee of Faculty of
Medicine and Health Sciences, Universiti Putra
Malaysia
• National Medical Research Register (NMRR)
• Permission from Hospital Tuankku Ja’afar,
Seremban and Hospital Tuanku Ampuan Najihah,
Kuala Pilah before commencement of the study
and pilot test
• Patient information sheet that explained the
purpose of the study and other informations
(risk, benefits) was given to patients and written
consent was obtained prior to data collection.
21

DATA ANALYSIS
Data was analyzed using Statistical Package for Social Sciences
Software, version 21.0. Level of significance of p<0.05.
•Data was tested for normality.
•Descriptive analysis: mean, standard deviation and 95% confidence
interval.
•Inferential analysis was carried out using independent t-test for
comparison of mean differences of scores and chi square. McNemar's
test was used to determine two sample proportions for detecting
changes in responses due to intervention
•One way ANOVA (to look at the group main effect)
•Two-way repeated measures ANOVA test was employed to look at
the main and interaction effects within and between means scores
for physical effects (nausea and vomiting), on each chemotherapy
counseling session. It used partial eta squared (η2
) as a measure of
effect size. 22

RESULTS
Response rate :
161patients out of 162 giving a response rate of 99.38%.
23

24
Characteristics Frequency, n (%) Total Test p value
Intervention group Control group
1.Age
< 45
45-54
55-64
> 64
Total
Mean, SD
95%CI
8(9.9)
14(17.3)
21(25.9)
38(46.9)
81(100)
67.46(1.38)
(66.08-68.84)
13(16.3)
15(18.8)
27(33.8)
25(31.1)
80(100)
63.52(1.43)
(62.09-64.95)
21(13.1)
29(18.0)
48(29.8)
63(39.1)
161(100)
65.49(1.41)
(64.08-66.90)
χ2
t
0.168
0.219
2.Gender
Male
Female
34(42.0)
47(58.0)
42(52.5)
38(47.5)
76(47.2)
85(52.8)
χ2
0.181
3.Race
Malay
Chinese
Indian
Others
44(54.3)
22(27.2)
14(17.3)
1(1.2)
40(50.0)
26(32.5)
10(12.5)
4(5.0)
84(52.2)
48(29.8)
24(14.9)
5(3.1)
χ2
0.394
4.Religion
Islam
Buddha
Hindu
Christian
Others
No Religion
44(54.3)
22(27.2)
14(17.3)
1(1.2)
0(0)
0(0)
40(50.0)
26(32.5)
10(12.5)
3(3.8)
1(1.2)
0(0)
84(52.2)
48(29.8)
24(14.9)
4(2.5)
1(0.6)
0(0)
χ2
0.527
5.Marital
Status
Single
Married
Widowed
Divorced
Separate
8(9.9)
54(66.7)
10(12.3)
5(6.2)
4(4.9)
3(3.8)
62(77.5)
11(13.7)
2(2.5)
2(2.5)
11(6.9)
116(72.1)
21(13.0)
7(4.3)
6(3.7)
χ2
0.306
Table 2: Socio- demographic characteristics of patients (n=161)

25
6.Number of
Children
No Child
1-2
3-4
>4
11(13.6)
26(32.1)
23(28.4)
21(25.9)
7(8.8)
27(33.7)
31(38.7)
15(18.8)
18(11.2)
53(32.9)
54(33.5)
36(22.4)
χ2
0.490
7. Number of
Family
member
Living
Together
None
1-2
3-4
>4
7(8.6)
20(24.7)
18(22.3)
36(44.4)
7(8.8)
17(21.2)
23(28.8)
33(41.2)
14(8.6)
37(23.0)
41(25.5)
69(42.9)
χ2 0.902
8. Education
level
Primary
Secondary
University
None
15(18.5)
32(39.5)
16(19.8)
18(22.2)
18(22.5)
23(28.8)
17(21.2)
22(27.5)
33(20.5)
55(34.2)
33(20.5)
40(24.8)
χ2
0.538
9. Working
Yes
No
Retired
32(39.5)
33(40.7)
16(19.8)
27(33.8)
28(35.0)
25(31.2)
59(36.6)
61(37.9)
41(25.5)
χ2
0.246
10.Monthly
Income
No income
< 1501
1501-3500
>3500
33(40.7)
14(17.3)
22(27.2)
12(14.8)
28(35.0)
18(22.5)
16(20.0)
18(22.5)
61(37.9)
32(19.9)
38(23.6)
30(18.6)
χ2
0.381

26
11. Cancer
Type
Breast
Colorectal
Cervical
Ovarian
Lymphoma
Stomach
Others
30(37.0)
23(28.4)
7(8.8)
4(4.9)
4(4.9)
6(7.4)
7(8.6)
18(22.5)
25(31.2)
8(10.0)
3(3.8)
6(7.5)
10(12.5)
10(12.5)
48(29.8)
48(29.8)
15(9.3)
7(4.3)
10(6.3)
16(9.9)
17(10.6)
χ2
0.516
12. Cancer
Stage
Stage 1
Stage 2
Stage 3
Stage 4
7(8.6)
16(19.8)
30(37.0)
28(34.6)
9(11.2)
12(15.0)
28(35.0)
31(38.8)
16(9.9)
28(17.4)
58(36.1)
59(36.6)
χ2
0.792
13. Number of
Chemo-
therapy
cycle
1st
cycle
2nd
cycle
49(60.5)
32(39.5)
47(58.8)
33(41.2)
96(59.6)
65(40.4)
.
χ2
0.418
14. Family
History of
Cancer
Yes
No
42(51.9)
39(48.1)
32(40.0)
48(60.0)
74(46.0)
87(54.0)
χ2
0.131

27
Intervention
group
Control group
16. Treated
with anti-
depressant
Yes
No
5(6.2)
76(93.8)
9(11.2)
71(88.8)
14(8.7)
147(91.3)
FET 0.194
17. Alternative
Medication
Yes
No
8(9.9)
73(90.1)
8(10.0)
72(90.0)
16(9.9)
145(90.1)
FET 0.539
18. Hormone
Medication
Yes
No
27(33.3)
54(66.7)
20(25.0)
60(75.0)
47(29.2)
114(70.8)
χ2
0.245
19.Joined
Cancer
Support
Society
Yes
No
5(6.2)
76(93.8)
1(1.2)
79(98.8)
6(3.7)
155(96.3)
FET 0.108
Chi square test (χ2
), Independent t test (t)
*Significant at p <0.05

28
Outcome
measures
Mean score(SD) p-value
Overall Intervention Control
Physical effects
Nausea 1.18(1.10) 1.21(1.11) 1.15(1.09) 0.731
Vomiting 1.45(1.10) 1.48(1.12) 1.41(1.08) 0.692
Table 6 : Baseline comparison on mean scores of physical effects (nausea and
vomiting) due to chemotherapy treatment for cancer patients between the
intervention and control group

29
Table 7 : Baseline comparison of physical effects (nausea and vomiting) due to chemotherapy
treatment for cancer patients between the intervention and control group.
Outcome measures Frequency, n (%) Total pa
value
Intervention group Control
Group
Physical Effects
1. Nausea
None
Mild
Moderate
Severe
Life- Threatening
28(34.6)
23(28.4)
18(22.2)
12(14.8)
0(0)
30(37.5)
20(25.0)
18(22.5)
12(15.0)
0(0)
58(36.0)
43(26.7)
36(22.4)
24(14.9)
0(0)
0.885
2. Vomiting
None
Mild
Moderate
Severe
Life-Threatening
19(23.5)
23(28.4)
22(27.1)
15(18.5)
2(2.5)
20(25.0)
23(28.8)
22(27.5)
14(17.5)
1(1.2)
39(24.2)
46(28.6)
44(27.3)
29(18.0)
3(1.9)
0.984

Nausea Frequency, n (%) Change
(%)
p value
Baseline 1st
counselling
None 28(34.6) 31(38.3) 3.7 0.019*
Mild 23(28.4) 25(20.9) -7.5
Moderate 18(22.2) 15(18.5) -3.7
Severe 12(14.8) 10(12.3) -2.5
Life threatening 0(0) 0(0) 0.0
Baseline 2nd
counselling
None 28(34.6) 33(40.7) 6.1 0.001*
Mild 23(28.4) 26(32.1) 3.7
Moderate 18(22.2) 14(17.3) -4.9
Severe 12(14.8) 8(9.9) -4.9
Life threatening 0(0) 0(0.0) 0.0
Baseline 3rd
counselling
None 28(34.6) 38(46.9) 12.3 0.001*
Mild 23(28.4) 27(33.3) 4.9
Moderate 18(22.2) 10(12.3) -9.9
Severe 12(14.8) 6(7.4) -7.4
Table 8a Change in physical effects: NAUSEA in the intervention group
p value was calculated using a Mc Nemar test
*Significant at p < 0.05

Table 8a Change in physical effects: NAUSEA in the intervention group
(%)
p value
1st
counselling 2nd
counselling
None 31(38.3) 33(40.7) 2.4 0.001*
Mild 25(20.9) 26(32.1) 11.2
Moderate 15(18.5) 14(17.3) -1.2
Severe 10(12.3) 8(9.9) -2.4
1st
counselling 3rd
counselling
None 31(38.3) 38(46.9) 8.6 0.001*
Mild 25(20.9) 27(33.3) 12.4
Moderate 15(18.5) 10(12.3) -6.2
Severe 10(12.3) 6(7.4) -4.9
2nd
counselling 3rd
counselling
None 33(40.7) 38(46.9) 6.2 0.001*
Mild 26(32.1) 27(33.3) 1.2
Moderate 14(17.3) 10(12.3) -5.0
Severe 8(9.9) 6(7.4) -2.5
Life threatening 0(0.0) 0(0.0) 0.0

(%)
p value
Baseline 1st
follow-up
None 30(37.5) 17(21.2) -16.3 0.001*
Mild 20(25.0) 23(28.8) 3.8
Moderate 18(22.5) 21(26.2) 3.7
Severe 12(15.0) 19(23.8) 8.8
Life threatening 0(0.0) 0(0) 0.0
Baseline 2nd
follow-up
None 30(37.5) 11(13.8) -23.7 0.001*
Mild 20(25.0) 27(33.8) 8.8
Moderate 18(22.5) 21(26.2) 3.7
Severe 12(15.0) 21(26.2) 11.2
Baseline 3rd
follow-up
None 30(37.5) 1(1.2) -36.3 0.001*
Mild 20(25.0) 28(35.0) 10.0
Moderate 18(22.5) 25(31.2) 8.7
Severe 12(15.0) 26(32.6) 17.6
Table 8b Change in physical effects: NAUSEA in the control group

Table 8b Change in physical effects: NAUSEA in the control group
Nausea Frequency, n (%) Change (%) p value
1st
follow-up 2nd
follow-up
None 17(21.2) 11(13.8) -7.4 0.017*
Mild 23(28.8) 27(33.8) 5.0
Moderate 21(26.2) 21(26.2) 0
Severe 19(23.8) 21(26.2) 2.4
1st
follow-up 3rd
follow-up
None 17(21.2) 1(1.2) -20 0.001*
Mild 23(28.8) 28(35.0) 6.2
Moderate 21(26.2) 25(31.2) 5.0
Severe 19(23.8) 26(32.6) 8.8
2nd
follow-up 3rd
follow-up
None 11(13.8) 1(1.2) -12.6 0.001*
Mild 27(33.8) 28(35.0) 1.2
Moderate 21(26.2) 25(31.2) 5.0
Severe 21(26.2) 26(32.6) 6.4

Table 8c Group main effect on Nausea at baseline, 1st
follow-up, 2nd
follow-up and 3rd
follow-up
Outcome measures Mean ± SD (95%CI) F p value
Intervention group
(n =81)
Control group
(n= 80)
Nausea One way
ANOVA
Baseline 1.21 ± 1.11(0.96-1.46) 1.15 ± 1.09(0.91-1.39) 0.015 0.731
1st
follow-up 1.09 ± 1.09(0.85-1.33) 1.58± 1.17(1.32-1.83) 7.565 0.007*
2nd
follow-up 0.96± 0.99(0.74-1.18) 1.70 ± 1.11(1.45-1.95) 19.787 0.001*
3rd
follow-up 0.80± 0.93(0.60-1.01) 2.01± 0.96(1.80-2.23) 66.066 0.001*

Table 8d Summary table of two way repeated measures ANOVA for Nausea
Source Type III
Sum of
Squares
df Mean
square
F p value Partial
Ƞ2
Nausea
Group 56.793 1 56.793 13.496 0.001* 0.078
Error(Between) 669.095 159 4.208
Time 4.393 2.640 1.664 15.875 0.001* 0.091
Group*Time 33.753 2.640 12.786 121.976 0.001* 0.434
Error (within) 43.998 419.733 0.105
*Significant at p<0.05

Figure 3 The interaction plot between group and time for means of Nausea

Table 8e Multiple pair wise comparisons of Nausea for the Intervention group
Group – time comparison
Pairs
Mean
difference
95% CI for
mean
difference
p
value
Pair 1
Baseline vs 1st
follow-up 0.123 0.024 - 0.223 0.007*
Pair 2
Baseline vs 2nd
follow-up 0.247 0.116 - 0.377 0.001*
Pair 3
Baseline vs 3rd
follow-up 0.407 0.259 – 0.556 0.001*
Pair 4
1st
follow-up vs 2nd
follow-up 0.123 0.024 – 0.223 0.007*
Pair 5
1st
follow-up vs 3rd
follow-up 0.284 0.148 – 0.420 0.001*
Pair 6
2nd
follow-up vs 3rd
follow-up 0.160 0.049 – 0.272 0.001*
Adjustment for multiple comparisons using Bonferroni test

Table 8f Multiple pair wise comparisons of Nausea for the control group
Pairs
Mean
difference
95% CI for
mean
difference
p
value
Pair 1
Baseline vs 1st
follow-up -0.425 -0.576 – (-0.274) 0.001*
Pair 2
Baseline vs 2nd
follow-up -0.550 -0.701 – (-0.399) 0.001*
Pair 3
Baseline vs 3rd
follow-up -0.863 -0.978 – (-0.747) 0.001*
Pair 4
1st
follow-up vs 2nd
follow-up -0.125 -0.226 – (-0.024) 0.007*
Pair 5
1st
follow-up vs 3rd
follow-up -0.438 -0.589 – (-0.286) 0.001*
Pair 6
2nd
follow-up vs 3rd
follow-up -0.313 -0.454 – (-0.171) 0.001*

Table 9a Change in physical effects: VOMITING in the intervention group
Vomiting Frequency, n (%) Change
(%)
p value
Baseline 1st
counselling
None 19(23.5) 23(28.4) 4.9 0.001*
Mild 23(28.3) 26(32.1) 3.8
Moderate 22(27.2) 20(24.7) 2.5
Severe 15(18.5) 10(12.3) -6.2
Baseline
2nd
counselling
None 19(23.5) 24(29.6) 6.1 0.001*
Mild 23(28.3) 27(33.4) 5.1
Moderate 22(27.2) 19(23.5) -3.7
Severe 15(18.5) 10(12.3) -6.2
Life threatening 2(2.5) 1(1.2) -1.3
Baseline 3rd
counselling
None 19(23.5) 38(46.9) 14.5 0.001*
Mild 23(28.3) 27(33.4) 5.1
Moderate 22(27.2) 10(12.3) -14.9
Severe 15(18.5) 6(7.4) -11.1

Table 9a Change in physical effects: VOMITING in the intervention group
(%)
p value
1st
counseling 2nd
counselling
None 23(28.4) 24(29.6) 1.2 0.001*
Mild 26(32.1) 27(33.4) 1.3
Moderate 20(24.7) 19(23.5) -1.2
Severe 10(12.3) 10(12.3) 0
1st
counselling 3rd
counselling
None 23(28.4) 38(46.9) 18.5 0.001*
Mild 26(32.1) 27(33.4) 1.3
Moderate 20(24.7) 10(12.3) -12.4
Severe 10(12.3) 6(7.4) -4.9
2nd
counselling 3rd
counselling
None 24(29.6) 38(46.9) 17.3 0.001*
Mild 27(33.4) 27(33.4) 0
Moderate 19(23.5) 10(12.3) -11.2
Severe 10(12.3) 6(7.4) -4.9

Table 9b Change in physical effects: VOMITING in the control group
(%)
p value
Baseline 1st
follow-up
None 20(25.0) 17(21.2) -3.8 0.029*
Mild 23(28.8) 23(28.8) 0
Moderate 22(27.5) 22(27.5) 0
Severe 14(17.5) 17(21.3) 3.8
Baseline 2nd
follow-up
None 20(25.0) 13(16.2) -8.8 0.001*
Mild 23(28.8) 25(31.3) 2.5
Moderate 22(27.5) 22(27.5) 0
Severe 14(17.5) 19(23.8) 6.3
Life threatening 1(1.2) 1(1.2) 0
Baseline 3rd
follow-up
None 20(25.0) 10(12.5) -12.5 0.001*
Mild 23(28.8) 27(33.8) 5.0
Moderate 22(27.5) 22(27.5) 0
Severe 14(17.5) 19(23.8) 6.3

Table 9b Change in physical effects: VOMITING in the control group
Vomiting Frequency, n (%) Change (%) p value
1st
follow-up 2nd
follow-up
None 17(21.2) 13(16.2) -5.0 0.046*
Mild 23(28.8) 25(31.2) 2.4
Moderate 22(27.5) 22(27.5) 0
Severe 17(21.2) 19(23.8) 2.6
Life threatening 1(1.2) 1(1.2) 0
1st
follow-up 3rd
follow-up
None 17(21.2) 10(12.5) -8.7 0.007*
Mild 23(28.8) 27(33.8) 5.0
Moderate 22(27.5) 22(27.5) 0
Severe 17(21.2) 19(23.8) 2.6
2nd
follow-up 3rd
follow-up
None 13(16.2) 10(12.5) -3.7 0.199
Mild 25(31.2) 27(33.8) 2.6
Moderate 22(27.5) 22(27.5) 0
Severe 19(23.8) 19(23.8) 0

Table 9c Group main effect on VOMITING at baseline, 1st
follow-up, 2nd
follow-up and 3rd
follow-up
Outcome measures Mean ± SD (95%CI) F p value
Intervention group
(n =81)
Control group
(n= 80)
Vomiting One way
ANOVA
Baseline 1.48 ± 1.12(1.23-1.73) 1.41 ± 1.09(1.17-1.65) 0.157 0.692
1st
follow-up 1.28 ± 1.09(1.04-1.52) 1.53± 1.09(1.28-1.77) 1.973 0.162
2nd
follow-up 1.22± 1.05(0.99-1.45) 1.63 ± 1.06(1.39-1.86) 5.874 0.016*
3rd
follow-up 0.80 ± 0.93(0.60-1.01) 1.70 ± 1.05(1.47-1.93) 33.123 0.001*

Table 9d Summary table of two way repeated measures ANOVA for VOMITING
*Significant at p<0.05
Source Type III
Sum of
Squares
df Mean
square
F p value Partial
Ƞ2
Vomiting
Group 21.814 1 21.814 5.133 0.025* 0.031
Error(Between) 675.730 159 4.250
Time 3.793 2.466 1.538 15.588 0.001* 0.089
Group*Time 19.669 2.466 7.794 80.833 0.001* 0.337
Error (within) 38.688 392.079 0.099

Figure 4 The interaction plot between group and time for means of VOMITING

Table 9e Multiple pair wise comparisons of VOMITING for the Intervention group
Pairs
Mean
difference
95% CI for
mean
difference
p
value
Pair 1
Baseline vs 1st
follow-up 0.198 0.077- 0.318 0.001*
Pair 2
Baseline vs 2nd
follow-up 0.259 0.127 - 0.392 0.001*
Pair 3
Baseline vs 3rd
follow-up 0.679 0.530 – 0.828 0.001*
Pair 4
1st
follow-up vs 2nd
follow-up 0.062 -0.011 – 0.135 0.146
Pair 5
1st
follow-up vs 3rd
follow-up 0.481 0.330 – 0.633 0.001*
Pair 6
2nd
follow-up vs 3rd
follow-up 0.420 0.270 – 0.569 0.001*

Table 9f Multiple pair wise comparisons of VOMITING for the control group
Pairs
Mean
difference
95% CI for
mean
difference
p
value
Pair 1
Baseline vs 1st
follow-up -0.112 -0.209 – (-0.016) 0.013*
Pair 2
Baseline vs 2nd
follow-up -0.212 -0.337 – (-0.088) 0.001*
Pair 3
Baseline vs 3rd
follow-up -0.287 -0.425 – (-0.150) 0.001*
Pair 4
1st
follow-up vs 2nd
follow-up -0.100 -0.191– (-0.009) 0.024*
Pair 5
1st
follow-up vs 3rd
follow-up -0.175 -0.291 – (-0.059) 0.001*
Pair 6
2nd
follow-up vs 3rd
follow-up -0.075 -0.155 – (-0.005) 0.080

DISCUSSIONAssociation between PHYSICAL EFFECTS and effectiveness of chemotherapy counselling
50
Association
between
PHYSICAL
EFFECTS
This
Study
Other Studies Discussion
Researcher Finding
Nausea ,
Vomiting
Yes Liekweg, et al.,
2004;
Wu, et al.,
2005
Yes Need for the pharmacist
involvement grew significantly with
the shift from a disease-centered to
a patient-centered care
Education for caregivers and
cancer patients given with
information on the available
effective strategies helps
improve nausea and vomiting

LIMITATIONS
• Time Constraint
51

CONCLUSION
• Chemotherapy counselling module developed
for pharmacist together with repetitive
counselling was effective among oncology
patients receiving chemotherapy in reducing
nausea and vomiting
52

RECOMMENDATIONS
• A multisite study is recommended in order to
achieve a more heterogeneous group of
population and to minimize cross
contamination that would affect the internal
validity of the study.
53

REFERENCES
• Al-Saffar, N., Abdulkareem, A., & Abdulhakeem, A. (2008). Depressed patients‘ preferences for education about medications by pharmacists in Kuwait. Patient Educ Couns , 72, 94-101.
Retrieved from http://dx.doi.org/10.1016/j.pec.2008.01.027
• Angotti, L. B., Post, G. R., Robinson, N. S., & Lewis, J. A. (2008). Pancytopenia with myeloplasia due to copper deficiency. Pediatric Blood and Cancer, 5 (5), 693-695. Retrieved from
DOI: 10.1002/pbc.21661
• August, Z., Eva-Maria, G., Johannes, M. G., Gerhard, R., Georg, K., Klaus, G., et al.(2010). Taste Alterations in Cancer Patients Receiving Chemotherapy: A Neglected Side Effect? Oncologist
, 15 (8), 913-920.
• Brennan, J. (2004). Cancer in context. Oxford: Oxford University Press.
• Chabner, B., & Longo, D. L. (2005). Cancer Chemotherapy and Biotherapy: Principles and Practice (4th edition ed.). Philadelphia: Lippincott Willians & Wilkins.
• Crawford, J. (2009). Hematopoietic growth factors: ESMO recommendations for the applications. Annals of Oncology, 20 (4), 162-165. Retrieved from DOI 10.1093/annonc/mdp162
• Dranitsaris, G., Maroun, J., & Shah, A. (2005). Estimating the cost of illness in colorectal cancer patients who were hospitalized for severe chemotherapy induced
diarrhea. Can J Gastroenterol. , 19, 83–7.
• Elting, L. (2007). Risk , outcomes, and costs of radiation-induced oral mucositis among patients with head- and neck malignancies. Int J Radiat Oncon Biol Phys , 68 (4), 1110-20. Retrieved
from DOI http://dx.doi.org/10.1016/j.ijrobp.2007.01.053
• Farooqui, M., Hassali, M. A., Shatar, A. K., et al., (2011). Qualitative exploration of Malaysian cancer patients' perspectives on cancer and its treatment. BMC Public
Health, 11:525 Retrieved from DOI 10.1186/1471-2458-11-525
• Friefeld, A., Bow, E., Sepkowitz, K., Boeckh, M., Mullen, C., Raad, I., et al. (2011). Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010
update by the infectious diseases Society of America. Clin Infect Dis, 52 (4), 56. Retrieved from DOI 10.1093/cid/cir073
• Gibbard, I., & Hanley, T. (2008). A five-year evaluation of the effectiveness of person-centred counselling in routine clinical practice in primary care.
• Counselling and Psychotherapy Research: Linking research with practice , 8 (4), 215-222. Retrieved from DOI: 10.1080/14733140802305440
• Hasanah, C. I., Naing L., Rahman, A.R. A. (2003). World Health Organization Quality of Life Assessment: Brief Version in Bahasa Malaysia. Medical Journal of Malaysia. 58:1
• Herbst, C. (2009). Prophylactic antibiotics or G-CSF for the prevention of infections and improvement of survival in cancer patients undergoing chemotherapy (Review). Cochrane
Collaboration.
• Herndon, C. M., Jackson II, K. C., & Hallin, P. A. (2002). Management of Opioid-Induced Gastrointestinal Effects in Patients Receiving Palliative Care. Pharmacotherapy, 22 (2). Retrieved
from DOI: 10.1592/phco.22.3.240.33552
• Howard-Anderson, J., Ganz, P., & Bower, J. (2012). Quality of life, fertility concerns, and behavioral health outcomes in younger breast cancer survivors: a systematic review. J Natl Cancer
Inst, 104, 386-405. Retrieved from DOI 10.1093/jnci/djr541
• Frame, D. (2010). Best practice management on CINV in oncology patients: I.Physiology and treatment of CINV. Multiple neurotransmitters and receptors and the need for combination
therapeutic approaches. J Support Oncol,8,5-9.
• Galimont-Collen, A., Vos, L., Lavrijsen, A., Ouwerkerkb, J., & Gelderblomb, H.(2007).Classification and management of skin, hair and nail and mucosal side-effects of epidermal growth
factor receptor (EGFR) inhibitors. Eur J Cancer, 43, 845-851.
• Ghafoor, Q., & Chetiyawardana, A. (2008). Nail changes secondary to docetaxel chemotherapy: a case report. Journal of Medical Case Reports , 2 (24).Retrieved from DOI:10.1186/1752-
1947-2-24
• Kadan-Lottick, N., Vanderwerker, L., Block, S., Baohui Zhang, Β. G., & Η, P. (2005). Psychiatric Disorders and Mental Health Service Use in Patients with Advanced Cancer. Cancer, 104 (12),
2872–2881.
• Kitano, T., Tada, H., Nishimura, T., Teramukai, S., Kanai, M., & Nishimura, T. (2007). Prevalence and incidence of anemia in Japanese cancer patients receiving outpatient chemotherapy.
International Journal of Hematology, 86 (1), 37-41. Retrieved from DOI 10.1532/IJH97.07040
• Kroenke, C., Rosner, B., & Chen, W. (2004). Functional impact of breast cancer by age at diagnosis. J Clin Oncol , 22, 1849-56. Retrieved from DOI 10.1200/JCO.2004.04.173
• Kroenke, M. K., Spitzer, M. R., & Williams, J. B. (2001). The PHQ-9 Validity of a Brief Depression Severity Measure. J Gen Intern Med , 16 (9), 606–613.
• Lawrence, D., Kupelnick, B., Miller, K., Devine, D., & Lau, J. (2004). Evidence report on the occurrence, assessment, and treatment of fatigue in cancer patients. J Natl Cancer Inst
Monogr. , 32, 40-50. Retrieved from DOI 10.1093/jncimonographs/lgh027
• Lew, M., Iacovelli, B., & Persson, B. L. (2008). Management of Chemotherapy-Induced Neutropenia: Opportunities for Pharmacist Involvement. Hospital Pharmacy, 43 (6), 472-484.
Retrieved from DOI 10.1310/hpj4306-472
54

• Liekweg, A., Westfeld, M., & Jaefde, U. (2004). From oncology pharmacy to pharmaceutical care: new contributions to multidisciplinary cancer care. Support Care
Cancer, 12, 73-75.
• Lim, C., Devi, M., & Ang, E. (2011). Anxiety in women with breast cancer undergoing treatment: a systematic review. Int J Evid Based Healthc, 9 (3), 215-35. Retrieved
from DOI: 10.1111/j.1744-1609.2011.00221.x
• Lim, G. (2006). Clinical oncology in Malaysia: 1914 to present. Biomed ImagingInterv J , 2 (1), e18. Retrieved from DOI 10.2349/biij.2.1.e18
• Maddireddy, U. R., Gogula, V. R., Pingali, U. R., Iyyapu, K. M., Avula, S., & Priyadarshni, R. (2004). Chemotherapy-Induced and/or Radiation Therapy– Induced Oral
Mucositis-Complicating the Treatment of Cancer. Neoplasia, 6 (5), 423 – 431.
• Marken, P., & Sommi, R. (2005). Eating disorders. Pharmacotherapy: A Pathophysiologic Approach. (J. DiPiro, R. Talbert, & G. Yee, Eds.) New York: McGraw Hill.
• Mohd Jamil, B., (2006). Validity and Reliability Study of Rosernberg Self- EsteemScale in Seremban school children. J Psychiatry, 15, 35-39.
• Markopoulos, C., Tsaroucha, A., Kouskos, E., Mantas, D., Antonopoulou, Z., & Karvelis, S. (2009). Impact of breast cancer surgery on the self-esteem and sexual life of
female patients. J Int Med Res., 37 (1), 182-8. Retrieved from DOI 10.1177/147323000903700122
• McGarvey, E., Baum, L., Pinkerton, R., & Rogers, L. (2001). Psychological sequelae and alopecia among women with cancer. Cancer Practice. , 9 (6), 283-289. Retrieved
from DOI: 10.1111/j.1523-5394.2001.96007.pp.x
• McMillan, S. C., & Weitzner, M.A. (2000). How problematic are various aspects of quality of life in patients with cancer at the end of life? Oncology Nursing Forum ,
27, 817-823.
• McMillan, S. C. (2002). Presence and severity of constipation in hospice patients with advanced cancer. American Journal of Hospice and Palliative Care, 19, 426-430.
Retrieved from DOI 10.1177/104990910201900616
• Minisini, A. (2003). Taxane-induced nail changes: incidence, clinical presentation and outcome. Annals of Oncology , 14, 333-337.
• Moscow, J., & Cowan, K. (2007). Biology of cancer. Cecil Medicine. ( 23rd edition ed.). (L. Goldman, & D. Ausiello, Eds.) Philadelphia: Saunders Elsevier.
• National Cancer Institute (NCI), 2008. Managing Chemotherapy Side Effects;Understanding Chemotherapy. Retrieved from
http://www.cancer.gov/cancertopics/coping/chemo-side-effects/understandingchemo.pdf
• National Cancer Institute (NCI), 2007. Managing Chemotherapy Side Effects; Chemotherapy and You”. Retrieved from
http://www.cancer.gov/cancertopics/coping/chemotherapy-and-you.pdf
• National Cancer Institute (NCI), (2004). Living beyond cancer: Finding a new balance. President’s cancer panel 2003–2004 annual report. Bethesda: MD: Department
of Health and Human Services, National Institutes of Health.
• National Pharmaceutical Bureau (BPFK). Ministry of Health. Retrieved March 5 2014, from http://portal.bpfk.gov.my/index.cfm
• National Cancer Institute(NCI), 2009. Common Terminology Criteria for Adverse Events. Version 4.0 (2009). Retrieved from
http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.02_2009-09-15_QuickReference_8.5x11.pdf
• Nirenberg, A., Bush, A., Davis, A., Friese, C., Gillespie, T., & Rice, R. (2006). Neutropenia: State of the knowledge part I. Oncology Nursing Forum , 33 (6), 1193-1201.
Retrieved from DOI 10.1188/06.ONF.1193-1201
• Pederson, K., Roerig, J., & Mitchell, J. (2003). Towards the pharmacotherapy of eating disorders. Expert Opin Pharmacother , 4, 1659-1678. Retrieved from DOI
10.1517/14656566.4.10.1659
• Possidente, C., Bucci, K., & McClain, W. (2005). Motivational interviewing: a tool to improve medication adherence? Am J Health Syst Pharm , 62, 1311-1314.
• Rehse, B., & Pukrop, R. (2003). Effects of psychosocial interventions on quality of life in adult cancer patients: meta analysis of 37 published controlledoutcome
studies. Patient Education and Counseling 50 , 179-186. Retrieved from DOI http://dx.doi.org/10.1016/S0738-3991(02)00149-0
• Reeves, G., Pirie, K., & Beral, V. (2007). Cancer incidence and mortality in relation to body mass index in the Million Women Study: cohort study.
• Richardson, G., & Dobish, R. (2007). Chemotherapy induced diarrhea. Journal of Oncology Pharmacy Practice , 13 (4), 181-198. Retrieved from DOI
10.1177/1078155207077335
• Rickles, N., Svarstand, B., & Statz-Paynter, J. (2006). Improving patient feedback about and outcomes with antidepressant treatment: a study in eight community
pharmacies. J Am Pharm Assoc ,46, 25-32
55

• Romita, F., Montanato, R., Corvasce, C., & DiBiscelgie, M. (2007). Is cancer-related fatigue more strongly correlated to hematological
or to psychological factor in cancer patients? Support Care Cancer , 16 (8), 943-946.
• Rosenberg, M. (1965). Society and the adolescent self-image. Princeton, NJ:Princeton University Press.
• Rosner, B. (2006). Fundamentals of Biostatistics. Vol. (10.5).Boston, Mass,Duxbury Press.
• Scrijvers, D., & Roila, F. (2009). Erythropoiesis-stimulating agents in the treatment of anaemia in cancer patients: ESMO Clinical
Practice Guidelines for use. Annals of Oncology , 159-161. Retrieved from DOI 10.1093/annonc/mdp161
• Sherina, M.S., Arroll, B., & Goodyear-Smith, F., (2012). Criterion Validity of the PHQ-9 (Malay Version) in a Primary Care Clinic in
Malaysia. Med JMalaysia, 67, 309-315.
• Sidik, S., Arroll, B., & Goodyear-Smith, F., (2012). Validation of the GAD-7(Malay Version) among women attending a primary care
clinic in Malaysia. J Prim Health Care, 4, 5-11.
• Spitzer, R., Kroenke, K., Williams, B., & Lowe, B. (2006). A Brief Measure for Assessing Generalized Anxiety Disorder. Arch Intern Med ,
166, 1092-1097. Retrieved from DOI 10.1001/archinte.166.10.1092.
• Tallon, B., Blanchard, E., & LJ, G. (2009). Permanent chemotherapy-inducealopecia: case report and review of the literature. J Am Acad
Dermatol , 63 (2), 333-336. Retrieved from DOI http://dx.doi.org/10.1016/j.jaad.2009.06.063
• Tamayo, A., & Diaz-Zuluaga, P. (2004) Management of opioid-induced bowel dysfunction in cancer patients. Supportive Care in Cancer,
12, 613-618. Retrieved from DOI 10.1007/s00520-004-0649-7
• Tianhong, L., & Roman, P. (2009). Skin toxicities associated with epidermal growth factor receptor inhibitors. Targ Oncol , 4, 107-119.
Retrieved from DOI 10.1007/s11523-009-0114-0
• Τrask, P., (2004). Quality of life and emotional distress in advanced prostate cancer survivors undergoing chemotherapy. Health and
Quality of Life Outcomes, 2, 37.
• Trotti, A., Byhardt, R., & Stetz, J. (2000). Common toxicity criteria (Version 2.0). An improved reference for grading the acute effects
of cancer treatment: Impact on radiotherapy. Int J Radiat Oncol Biol Phys , 47, 13–47. Retrieved from DOI
http://dx.doi.org/10.1016/S0360-3016(99)00559-3
• Trüeb, R. (2010). Chemotherapy-induced hair loss. Skin Therapy Lett., 15 (7), 5-7.
• Vadhan-Raj, S. (2009). Management of Chemotherapy-induced thrombocytopenia: Current status of thrombopoietic agents. Semin
Hematol , 46 (1 Suppl 2), S26-32. Retrieved from DOI http://dx.doi.org/10.1053/j.seminhematol.2008.12.007
• Weis, J. (2011). Cancer-related fatigue: prevalence, assessment and treatment strategies. Expert Rev Pharmacoecon Outcomes Res ,
11 (4), 441-6.
• Wells, M., Macmillan, M., & Raab, G. (2004). Does aqueous or sucralfate cream affect the severity of erythematous radiation skin
reactions? Radiotherapy and Oncology, 73, 153-62. Retrieved from DOI http://dx.doi.org/10.1016/j.radonc.2004.07.032
• World Health Organization, (2007). Ten statistical highlights in global public health. World Health Statistics 2007. Geneva: World
health Organization.
• Wu, H., Graff, L., & Yuen, C. (2005). Clinical pharmacy in an inpatient leukemia and bone marrow transplant service. Am J Health-Syst
Pharm, 62, 744-747.
• Zanni, G. (2005). Help for chemotherapy-induced nausea and vomiting. Pharm Times.
• Zhen Guo, H.-y. T., Sheng-kui, T., Kai-hua, F., Yin-chun, H., Qing, B., & Wei, J. (2013). The benefits of psychosocial interventions for
cancer patients undergoing radiotherapy. Health and Quality of Life Outcomes , 11, 121.
• Zimmermann, M. B., Chaouki, N., & Hurrell, R. F. (2005). Iron deficiency due to consumption of a habitual diet low in bioavailable iron:
a longitudinal cohort study in Moroccan children. American Journal of Clinical Nutrition , 81 (1), 115-121.
56

Effectiveness of Chemotherapy Counseling by Pharmacists

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Viewers also liked

Viewers also liked (6)

Similar to Effectiveness of Chemotherapy Counseling by Pharmacists

Similar to Effectiveness of Chemotherapy Counseling by Pharmacists (20)

More from Global R & D Services

More from Global R & D Services (20)

Recently uploaded

Recently uploaded (20)

Effectiveness of Chemotherapy Counseling by Pharmacists