Patient barriers to participation in clinical trials at a community cancer center.

Abstract

17 Background: Clinical trials are fundamental to innovative oncology. Participation rates in trials have declined nationally to < 5%. Barriers to participation exist at patient, physician, and protocol levels. This study seeks to identify barriers to enrollment in clinical trials at a community cancer center serving a diverse patient population. Methods: We conducted a descriptive cross-sectional study, including 160 eligible patients offered enrollment in 27 clinical trials from July 2010-December 2012. A standardized questionnaire was delivered by mail or in person. Patients who enrolled (acceptors) and decliners were compared using Fisher’s exact test for nominal variables and t test for normally distributed continuous variables. Results: Fifty-seven patients (36%) (males: 10, females: 47) returned the questionnaire. Thirty-three (58%) were enrolled in a clinical trial. Mean age of acceptors was 57 compared to 64 for decliners (p=0.007). Stage IV disease patients were more likely to enroll (Spearman rho= 0.33, p=0.01). Among patients with family support, 66% accepted participation compared to 40% of those without [p=0.05]. Twenty-eight of 33 (85%) who felt trust in their doctor affected their decision enrolled. Of those “comfortable with randomization,” 86% enrolled compared to 29% who were not [p<0.001]. 74% patients would participate in a trial if maximal information could be gathered before making a final decision. Acceptors stated altruism, contribution to research, trust in doctor and hope for cure while decliners mentioned uncertainty in research, drug side effects, mistrust in pharmaceutical industry and depression as most important reasons for their decision. Conclusions: Our results confirm barriers among diverse patients treated at a community cancer center. Study limitations include small sample size and predominance of female gender. Factors influencing enrollment identified include age, family support, patient’s insight into conduct of randomized trials, perceived drug side effects and the doctor-patient relationship. Success lies in bridging knowledge and communication gaps, careful protocol design, and establishing trusting relationships.