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.
Participation in clinical trials as viewed by the patient: understanding cultural and emotional aspects which influence choice / C. Catania, T. De Pas, A. Goldhirsch, D. Radice, L. Adamoli, M. Medici, E. Verri, C. Marenghi, F. de Braud, F. Nolè. - In: ONCOLOGY. - ISSN 0030-2414. - 74:3-4(2008 Sep), pp. 177-187.
Participation in clinical trials as viewed by the patient: understanding cultural and emotional aspects which influence choice.
F. de Braud;
2008
Abstract
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.Pubblicazioni consigliate
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