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Original Articles

Do Cancer Patients Fully Understand Clinical Trial Participation? A Pilot Study to Assess Informed Consent and Patient ExpectationsFootnote*

, , , &
Pages 21-24 | Published online: 05 Dec 2007
 

Abstract

Background. Accepted practices of informed consent often result in suboptimal patient understanding of research studies. Methods. This pilot study aimed to assess trial-specific tailored materials, compared to a widely used generic booklet about clinical trials, randomly assigned to 118 candidates for cancer clinical trials. Study outcomes were: satisfaction with decision-making; satisfaction with materials; and subjective understanding of the clinical trial. Results. There were no major differences between groups. Participants rated tailored materials higher as a useful reference. Conclusions. Trial-specific materials hold utility for reference during clinical trials. Studies of informed consent are feasible, although important factors limit research. J Cancer Educ. 2007; 22:21–24.

Notes

*Supported by the Dana-Farber Cancer Institute.

20. O'Connor AM, Stacey D, Entwistle V, et al. Decision aids for people facing health treatment or screening decisions [update of Cochrane Database Syst Rev. 2001;(3): CD001431; PMID: 11686990]. Cochrane Database Syst Rev. 2003: CD001431.

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