Clinical trial participation among patients with advanced cancer: What characteristics most influence enrollment?

Abstract

9073 Background: Studies using administrative data report that patients belonging to racial/ethnic minority groups are less likely to be enrolled in clinical trials. We studied a cohort of terminally ill cancer patients to determine: a) if the observed lower rate of racial/ethnic minority trial enrollment was accounted for by psychosocial confounding factors, and b) the factors most associated with clinical trial enrollment. Methods: Coping with Cancer (CwC) is an NCI/NIMH-funded multi-site, prospective longitudinal study of patients with advanced cancer. Baseline interviews with 358 patients captured clinical trial enrollment as well as patients’ medical status and psycho-social characteristics. Logistic regression models estimated associations between enrollment and select baseline characteristics. Stepwise, backward and subset model selection procedures were applied to identify confounding variables. Baseline characteristics significant at α= 0.05 were retained in the final model. Results: At baseline, a median of 4.4 months prior to death, 35 of 358 patients (9.8%) reported being enrolled in a trial. In unadjusted analyses, race/ethnicity, health insurance coverage, performance status, recruitment from Yale Cancer Center, having pancreatic or lung cancer, preferring life-extending care, not having discussed end-of-life care and not wanting to discuss life-expectancy with their physician were associated (p<0.05) with enrollment. In multivariate analysis, patients not reporting an end-of-life discussion (AOR, 0.18; 95%CI 0.04-0.72), not wanting to discuss life-expectancy (AOR, 0.31; 95%CI 0.04-0.83), and those receiving care at Yale (AOR, 12.26; 95%CI 1.09-4.84) were more likely than other patients to be trial enrollees. Conclusions: Patient race/ethnicity was not associated with clinical trial enrollment after adjustment for psychosocial covariates. Patients endorsing less engagement in discussions about end-of-life planning were more likely to be enrolled in a clinical trial.