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  • Welcome, this afternoon I will give a short update about a pilot project on the quality of life of long-term cancer survivors within EORTC phase III clinical trials. This project is a joint collaboration between the EORTC quality of life group and the EORTC genito-urinary tract cancer group. PI’s on the projects are Neil Aaronson and Susan Osanto chair of EORTC GU group.
  • Before I start talking in detail about the project, I want to define who is a cancer survivor. According the National Coalition of Cancer Survivors cancer survivorship starts from the time of its discovery and an individual stays a survivor for the rest of his or her life. The U.S. National Cancer Institute also includes family members, friends and caregivers in this definition. [click] For this study we focus on permanent survival which can be equated with cure.
  • To date there are more than 10 million cancer survivors. [click] However a life free of cancer is not synonymous with a life free of physical and psychosocial health problems. Survivors can suffer from treatment induced morbidity like cardiovascular damage due to chemotherapy or radiation, secondary tumors Also chronic disease- and treatment related symptoms are common like fatigue Functional impairment like sexual or cognitive dysfunction can occur Survivors can suffer from psychosocial problems, for instance fear of disease recurrence or work disability But also practical problems, like obtaining loans or health insurance are observed in survivors
  • It’s only recently that we can start to concentrate on the quality of life of survivors, since before most important objective of treatment was that patients could survive. [click] Therefore studies on quality of life of long-term cancer survivors are quite scarce. Knowledge on the long-term HRQoL can improve cancer treatment by minimizing long-term complications. [click] Therefore we should study treatment related late effects. [click] US studies on ethnic differences in cancer survivors show differences in HRQoL, social functioning, incidence and mortality and survival rates. This could be a consequence of differences in symptom perception, report, and experience. Until now there is only one study investigating ethnic differences across countries, namely the study of Namiki who compared PCS in Japan and the US. [click] Therefore studies on cultural difference across countries are needed.
  • In the US Ganz and colleagues completed in 2009 a similar study in long term cancer survivors in the US. She showed that to be successful in this kind of projects it is important that the different treatment sites cooperate and are committed to give the study priority. Problems these sites are facing are medical ethical approval, short of site resources and staffing caused by for example coordinator transitions or leave of PI’s. Problems in trial administration of the treatment sites can cause problems with locating patients. [click] Additionally patients have to be willing to cooperate [click] In this study a small proportion of potential survivors was not included since 5 clinics refused to participate. More than half of potential survivors got lost because of problems within treatment sites. And finally about 30% of the contacted survivors refused to cooperate.
  • In this study we will make use of previous EORTC trials, [click] since the EORTC operates in an international context. Databases of the EORTC trials are large and mature and the trial structure makes it possible to control for differences across countries in patient, disease and treatment characteristics. At last within the EORTC context we can make use of a network of MD’s and PhD’s.
  • The objectives of this pilot study are to investigate the feasibility of cross-cultural long-term follow-up in phase III clinical trials and [click] to lay the groundwork for future cross-cultural studies in long-term survivors. We will test the logistics involved in this kind of projects, the medical ethical procedures we need to follow in the different countries and how to identify and localize disease free patients after 5 to 10 years. Another objective is to pilot test the questionnaire in multiple countries.
  • In this pilot study we will focus on two cancers. Since this pilot study is a collaboration with the EORTC GU group we will focus on testicular cancer and prostate cancer. [click] TCA affects young adults. Over 90% of the patients can be cured, and have a life expectancy similar to age-matched peers from the general population. However one potential limitation of focusing this pilot study on TCa is that it is a relatively rare disease. For this reason, this study will also be directed towards men with prostate cancer. [click] Prostate cancer is currently the most prevalent cancer among men in Western, industrialized countries. For men diagnosed with local or loco-regional PCa, survival rates are over 90%. However, men affected with PCA are relatively old, which makes research rather complicated, because of patients being very elderly, suffering comorbidity or being deceased.
  • The testicular cancer survivors in this study participated in EORTC trial 30941 which investigated different regimen of BEP. We will invite survivors from England, Italy, the Netherlands and Norway. [click] The prostate cancer survivors come from EORTC trial 22911 which investigated radiotherapy vs wait and see policy. Patients from Belgium, France, Italy and the Netherlands will be invited to participate. The median age of the people was then 65, by now the average age of the survivors is 75. Therefore we are anticipating that a fair number of patients will be very elderly or will have died. To compensate for this loss of patients, we will recruit additional patients aged 65 to 75 from the clinics that were included in this clinical trial.
  • We will make use of the following questionnaires: At the generic level we will make use of the SF-36 [click] At the cancer specific level the the QLQ-C30 and [click] the prostate cancer or testicular cancer module. The latter one is currently under development under supervision of Bernhard Holzner. [click] At the cancer survivor specific level we make use of the impact of cancer questionnaire version 2. [click] We also will ask some additional questions on basic demographics and [click] in testicular cancer survivors only we will ask questions on work related subjects like job satisfaction.
  • At this moment the biggest challenge seems to be to contact alive and disease free patients. In each country we will have to follow different procedures to locate the survivors.
  • After collecting data we will perform basic psychometrics. [click] We will determine success based on a minimal response rate of 50%, however we prefer a response rate over 70%. Missing items should be below 5% per questionnaire and Cronbach's alpha should be at least .70
  • At this moment we’ve finished translating all questionnaires and patient letters. [click] All treatment sites have committed themselves to the study. [click] The study is approved by the Dutch IRB, and is awaiting approval in Norway and Italy. In France the study does not require IRB approval. In England getting IRB approval is rather complex, and we’ve just made the first steps. [click] Prostate cancer survivors of two Dutch hospitals are ready to be invited for participation. In France the first questionnaires have been sent out
  • What are our plans for the coming 1.5 years. [click] First we have to obtain IRB approval in all countries and all hospitals. [click] When in a country or hospital IRB approval is obtained, we can start to check medical records and to contact GP’s to acquire information on the health status of the patients. [click] After that we can send out questionnaires. Probably this will take the coming 1 year. [click] After that I can start data analyses and to publish.
  • Thank you for your attention, are there any questions or remarks?

Spring Meeting Eortc Spring Meeting Eortc Presentation Transcript

  • Marieke van Leeuwen, PhD PI’s Neil Aaronson and Susanne Osanto Methods and Measures for Assessing Quality of Life of Long-Term Survivors of Testicular and Prostate Cancer Michel Bolla, Fabio Efficace, Sophie D. Fosså, Bernhard Holzner, Lonneke van de Poll-Franse, Hendrik van Poppel, and Ronald de Wit 1 1 alphabetic order
  • Who is a cancer survivor?
    • National Coalition of Cancer Survivors:
    • "From the time of its discovery and for the balance of life, an individual diagnosed with cancer is a survivor."
    • U.S. National Cancer Institute:
    • "An individual is considered a cancer survivor from the time of diagnosis, through the balance of his or her life. Family members, friends, and caregivers are also impacted by the survivorship experience and are therefore included in this definition.“
    • Permanent survival : roughly equated with “cure” Focus on long-term risks (e.g., 2nd primaries) and effects (e.g., chronic fatigue) 1
    1 Mullan (1985), NEJM
  • Introduction and background
    • More than 10 million cancer survivors 1
    • Large cohorts of patients enjoy disease-free survival of 5 years or longer
    • Disease free ≠ life free of physical and psychosocial health problems
      • Treatment induced morbidity
      • Chronic disease- and treatment related symptoms
      • Functional impairment
      • Psychosocial problems
      • Practical problems
    1 Ganz (2007) Cancer Survivorship: Today and Tomorrow
  • Develop large scale cancer survivorship program
      • Cancer survival rates are improving
      • Few studies cancer survivors >5 years, >10 years scarcer 1
      • Knowledge long-term HRQoL -> effective intervention minimizing long-term complications
    • Treatment related late effects
      • U.S. studies ethnic differences in cancer survivors in:
        • HRQoL
        • Social functioning
        • Incidence
        • Mortality and survival rates
      • Due to symptom perception, report, and experience
      • Only single country cross cultural studies, one exception 2
    • Cross-cultural differences
    1 Joly et al. (2002) Journal of Clinical Oncology 2 Namiki et al. (2009) Prostate Cancer Prostatic Diseases
  • Possible obstacles
    • Treatment sites have to cooperate and should be committed
      • METC
      • Site resources/staffing
      • Trial administration
    • Patients have to cooperate
    Ganz et al. (2009), J Cancer Surviv
  • Potential contribution of EORTC to survivorship research
      • EORTC uniquely positioned to investigate cross-cultural differences in survivorship experience
      • Large, mature databases of patients treated in the context of controlled clinical trials
      • RCT context facilitates controlling for disease-and treatment-related factors (i.e., case mix problem)
      • Network of MD’s and PhD’s
  • Objectives
    • To test the feasibility of cross-cultural long-term follow-up in phase III clinical trials (of the EORTC).
    • To lay groundwork for future, substantive studies on the cross-cultural differences in the (long-term) survivorship experience of cancer patients :
      • To identify practical and ethically acceptable procedures for recruiting patients from EORTC clinical trials for long-term HRQL survivorship studies
      • To create an HRQL assessment package including generic, cancer-specific and survivor-specific questionnaire elements .
  • Focus of this Pilot Study
    • Testicular Cancer
      • Affects young adults
      • Over 90% cured, normal life expectancy 1
      • However it is a rare disease
    • Prostate Cancer
      • Most prevalent cancer among men in the west 2
      • Depending on stage of disease survival rates over 90% 3
      • But affects relatively old men
    1 Fosså (2007) Cancer Survivorship: Today and Tomorrow 2 Parkin et al., (2001) Eur J Cancer 3 American Cancer Society (2008) What Are the Key Statistics About Prostate Cancer?
  • Subjects phase III EORTC clinical trials
    • TCS EORTC 30941
      • Investigated 4 different schedules of bleomycin, etoposide, and cisplatin (BEP) chemotherapy (four v three cycles given over 5 v 3 days)
      • 1995-1998
      • England, Italy, Netherlands, Norway
      • 35 per country
      • Extra patients will be contacted outside of the trial in Italy
    • PCS EORTC 22911
      • post-operative external radiotherapy vs wait and see in pathological stage T3 NO prostate cancer
      • 1992-2001
      • Belgium, France, Italy, Netherlands
      • 35 per country
      • Median age 65
      • Extra patients outside of the trial will be contacted if necessary
  • Measures
    • Generic: SF-36
    • Cancer-specific:
      • QLQ-C30
      • PR25/TC26 1
    • Cancer-survivor specific
      • IOCv2
      • additional questions
      • subscales QPS Nordic for TCS only
    3. Would you like to work fewer hours per week if it was economically possible? Absolutely not / rarely / uncertain / maybe/ absolutely 1 2 3 4 5 5. What is your present marital status? □ Married / living together □ Divorced / separated □ Widow / widower / partner diseased □ In a relationship but living apart □ Never been married / never been living together 6. I feel a sense of pride or accomplishment from surviving cancer 9. Having had cancer makes me feel unsure about my future Strongly disagree 1 Disagree 2 Neutral 3 Agree 4 Strongly agree 5 4. During the past 4 weeks , have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Yes/No a) Cut down on the amount of time you spent on work or other activities b) Accomplished less than you would like c) Were limited in the kind of work or other activities d) Had difficulty performing the work or other activities (for example, it took extra time) 25. Have you had difficulty remembering things? Not at all/ A little / Quite a bit / Very much 1 2 3 4 31. Have you had to urinate frequently during the day? Not at all/ A little / Quite a bit / Very much 1 2 3 4 18. Have you felt less masculine as a result of your disease or treatment? Not at all/ A little / Quite a bit / Very much 1 2 3 4 1 phase 1/2 completed, PI Bernhard Holzner
  • How to verify vital status and contact disease-free patients?
    • the Netherlands: via hospital records and general practitioner
    • Belgium: patients are still in follow-up
    • Norway: patients are in centralized follow-up and disease status can be checked in cancer registry
    • England, France and Italy: part of the research, e.g. in Italy patients keep their hospital records with them
  • Psychometrics
    • Descriptive statistics
    • Multi-trait scaling analyses
    • Factor analysis
    • Cronbach’s α
    • Minimal response rate 50% (preferably > 70%)
    • Missing items per questionnaire below 5%
    • Cronbach’s α at least .70
    Determination of success
  • Where are we now:
    • All questionnaires and patient letters have been translated
    • All treatment sites in England, Italy, Norway, Belgium and France have committed themselves to the study
    • Approval by Dutch IRB
    • In Norway and Italy the study is awaiting approval by the IRB
    • In France the study does not require IRB approval
    • In England we’ve started to prepare for IRB approval
    • In two Dutch hospitals medical records have been checked
    • In France questionnaires have been sent out
  • Time Schedule start November 2009* 6 months 12 months 18 months now
    • Obtaining ethical approval
    • Checking medical records
    • Contacting GP’s
    • Sending out questionnaires
    • Checking medical records
    • Contacting GP’s
    • Sending out questionnaires
    • Data analyses
    • Writing papers
    *Real start May, but on hold from July until November because of maternity leave
  • Thank you for your attention Questions?