Returning research results to clinical trial participants: A survey of patients with cancer.

Abstract

2611 Background: The disclosure of trial results (TR) in early stage breast cancer patients (pts) is not well characterized and there is a paucity of information regarding the attitudes of adult cancer pts with tumors in other sites. The purpose of this study was to determine the preferred method of sharing TR with clinical trial participants. Methods: A survey was given to cancer pts who participated in clinical trials at the Tom Baker Cancer Centre via mail (250) or during a clinic visit. Clinical trial participants provided demographic information and indicated their preferred mode of communication of TR, timing and attitudes regarding return of TR, and whether there is a difference of opinion if the clinical trial findings were positive or negative. Results: 146 clinical trial participants completed the survey (median age 59; 68% female; 94% Caucasian; 70% postsecondary education; type of cancer: breast n=84, prostate n=26, other n=36). The majority of patients were treated with adjuvant intent (82%) and had home internet access (92%). Most pts (92%) felt they had a right to receive results of the research they took part in. The preferred method of notification of positive TR was a letter (53%); internet website/email was acceptable in 22%. For negative TR, internet website/email and letter were acceptable in 10% and 31% respectively. Significantly more pts preferred a personal visit for negative TR (43%) compared to positive TR (18.4%) (p<0.0001). 43% of patients preferred a personal visit to a clinic or research lab to get negative results compared to only 18% of patients that receive positive results (p<0.0001). 86% of clinical trial participants would like to receive TR as soon as the study is accepted to be published or sooner. 66% of pts wanted their next of kin to be notified of TR in the event of the pt’s death. 51% of pts would be more likely to participate in a clinical trial if investigators provided TR. Conclusions: The vast majority of clinical trial participants felt that they had a right to receive TR and many viewed receipt of TR as an incentive to participate in clinical trials. Although most pts had internet access, the preferred notification mode was letter for positive TR and in person for negative TR.