Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy.

Z. A. nurgat, Wendy Laura Craig, Neil Crawford Campbell, Donald Bissett, J. Cassidy, M. C. Nicolson

Research output: Contribution to journalArticle

97 Citations (Scopus)

Abstract

Successful advances in the treatment of advanced malignant diseases rely on recruitment of patients into clinical trials of novel agents. However, there is a genuine concern for the welfare of individual patients. The aim of this study was to examine motives of patients entering early clinical trials of novel cancer therapies. Questionnaire survey with both open- and close-ended questions. The patients were surveyed after they had given informed consent and before or during the first cycle of treatment. In all, 38 phase I/II trial patients participated and completed the survey. Obtaining possible health benefit was listed by 89% as being a 'very important' factor in their decision to participate, with only 17% giving reasons of helping future cancer patients and treatment. Other items cited as a 'very important' motivating factor were 'trust in the doctor' (66%), 'being treated by the latest treatment available' (66%), 'better standard of care and closer follow-up' (61%), and 'closer monitoring of patients in trials' (58%). Only 47% patients indicated that someone had explained to them about any 'reasonable' alternatives to the trial. In total, 71% strongly agreed that 'surviving for as long time as possible was the most important thing (for them)'. Nearly all (97%) indicated that they knew the purpose of the trial and had enough time to consider participation in the trial (100%). In this survey, most patients entering phase I and II clinical trials felt they understood the purpose of the research and had given truly informed consent. Despite this, most patients participated in the hope of therapeutic benefit, although this is known to be a rare outcome in this patient subset. Trialists should be aware, and take account of the expectations that participants place in trial drugs.

Original languageEnglish
Pages (from-to)1001-1005
Number of pages4
JournalBritish Journal of Cancer
Volume92
DOIs
Publication statusPublished - 2005

Keywords

  • informed consent
  • phase I/II cancer clinical trials
  • patient motivations
  • ANTICANCER DRUG TRIALS
  • QUALITY-OF-LIFE
  • INFORMED CONSENT
  • THERAPEUTIC MISCONCEPTION
  • AGENTS
  • EXPECTATIONS
  • RECRUITMENT
  • PERCEPTIONS
  • DESIGN
  • RISKS

Cite this

nurgat, Z. A., Craig, W. L., Campbell, N. C., Bissett, D., Cassidy, J., & Nicolson, M. C. (2005). Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy. British Journal of Cancer, 92, 1001-1005. https://doi.org/10.1038/sj.bjc.6602423

Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy. / nurgat, Z. A.; Craig, Wendy Laura; Campbell, Neil Crawford; Bissett, Donald; Cassidy, J.; Nicolson, M. C.

In: British Journal of Cancer, Vol. 92, 2005, p. 1001-1005.

Research output: Contribution to journalArticle

nurgat, Z. A. ; Craig, Wendy Laura ; Campbell, Neil Crawford ; Bissett, Donald ; Cassidy, J. ; Nicolson, M. C. / Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy. In: British Journal of Cancer. 2005 ; Vol. 92. pp. 1001-1005.
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AB - Successful advances in the treatment of advanced malignant diseases rely on recruitment of patients into clinical trials of novel agents. However, there is a genuine concern for the welfare of individual patients. The aim of this study was to examine motives of patients entering early clinical trials of novel cancer therapies. Questionnaire survey with both open- and close-ended questions. The patients were surveyed after they had given informed consent and before or during the first cycle of treatment. In all, 38 phase I/II trial patients participated and completed the survey. Obtaining possible health benefit was listed by 89% as being a 'very important' factor in their decision to participate, with only 17% giving reasons of helping future cancer patients and treatment. Other items cited as a 'very important' motivating factor were 'trust in the doctor' (66%), 'being treated by the latest treatment available' (66%), 'better standard of care and closer follow-up' (61%), and 'closer monitoring of patients in trials' (58%). Only 47% patients indicated that someone had explained to them about any 'reasonable' alternatives to the trial. In total, 71% strongly agreed that 'surviving for as long time as possible was the most important thing (for them)'. Nearly all (97%) indicated that they knew the purpose of the trial and had enough time to consider participation in the trial (100%). In this survey, most patients entering phase I and II clinical trials felt they understood the purpose of the research and had given truly informed consent. Despite this, most patients participated in the hope of therapeutic benefit, although this is known to be a rare outcome in this patient subset. Trialists should be aware, and take account of the expectations that participants place in trial drugs.

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