Reasons given by patients for participating, or not, in Phase 1 cancer trials

Catt, S.L., Langridge, C.I, Fallowfield, L.J, Talbot, D. C. and Jenkins, V.A. (2011) Reasons given by patients for participating, or not, in Phase 1 cancer trials. European Journal of Cancer, 47 (10). pp. 1490-1497. ISSN 0959-8049

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Background: Communication with patients contemplating Phase 1 cancer trial participation can be challenging. Controversy exists as to whether they are provided with sufficient information to give genuinely informed consent. We present data examining the reasons patients gave for trial entry. Method: Following discussions with oncologists about Phase1 trials, participants completed a 19-item study specific ‘accept or decline measure’ exploring hope, expectations of benefit, altruism, concerns, and general perceptions of the trial information. They also completed 2 standardised questionnaires measuring psychological morbidity and predisposition towards optimism. Results: Forty patients completed the study questionnaires. Patients were generally optimistic with few concerns about the experimental nature of Phase 1 trials. Most 36/40 (90%) consented to trial entry. Fifty-one percent thought the trial was the only treatment option available. The four main reasons for trial entry were: expectation of some medical benefit (21%); trial the best available option (21%); to maintain hope (15%) and to help with research (13%). Only one patient gave altruism as their main reason for trial participation. Conclusion: Patients considering Phase 1 trials may be a self-selected group with optimistic expectations of personal benefit driving trial entry rather than altruism. Achieving genuinely informed consent and avoidance of therapeutic misconceptions in such patients may be difficult.

Item Type: Article
Additional Information: CODEN: EJCAE
Keywords: Cancer Phase 1 trials Motivation Reasons Communication Trial participation
Schools and Departments: Brighton and Sussex Medical School > Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
Subjects: R Medicine > R Medicine (General)
R Medicine > R Medicine (General) > R723 Medical philosophy. Medical ethics
R Medicine > R Medicine (General) > R726.5 Medicine and disease in relation to psychology. Terminal care.
R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology Including cancer and carcinogens
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Depositing User: Tracy Woodcock
Date Deposited: 26 Aug 2011 15:33
Last Modified: 18 Jun 2013 11:46
Google Scholar:1 Citations
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