Background: Patients invited to take part in a clinical trial may evoke an archetype on which they may base their decision of adherence to participation, instead of on the study itself.
Methods: A 17-item, multiple choice questionnaire was developed, tested and then administered to 102 Italian-speaking patients with advanced lung or breast cancers who had never been exposed to participation in a trial.
Results: The questionnaire was answered by all patients. Eighty-five percent were positive about trial participation. Demographic factors did not influence patients' willingness to participate. Trust in the investigator (76%) or in the institute (64%) and hope of receiving a new chance for cure (78%) were cited as reasons to accept participation. A minority was concerned by potential conflicts of interest (31%) or the thought of being 'guinea pigs' (36%), and feared that doctors were interested in advancing their own research, even though there were more efficient drugs available (28%). Fifty percent feared receiving a little-known medicine, and 76% considered that a thorough explanation of toxicity/safety of the proposed treatment helped them decide.
Conclusion: Several prejudices, fears and some hopes have been captured by the questionnaire. Understanding such specifics will improve patient information leading patients to a more conscious motivation in deciding whether to participate in a clinical trial.
(c) 2008 S. Karger AG, Basel.