A population-based study of invitation to and participation in clinical trials among women with early-stage breast cancer.

Abstract

Although many studies clearly demonstrate disparities in cancer clinical trial enrollment, there is a lack of consensus on potential causes. Furthermore, virtually nothing is known about associations between patients' decision-making style and their participation in clinical trials. Women with newly diagnosed, stage 0-II breast cancer reported to the Georgia and Los Angeles County Surveillance, Epidemiology, and End Results (SEER) registries in 2013-2014 were surveyed approximately seven months after diagnosis. We investigated two primary outcome variables: (1) invitation to participate in a clinical trial, (2) participation in a clinical trial. We evaluated bivariate associations using Chi-squared tests and used multivariable logistic regression models to investigate associations between patient variables, including decision-making style, and the primary outcomes. 2578 patients responded (71% response rate); 30% were > age 65, 18% were black, 18% were Latina, 29% had ≤ high school education. 10% of patients reported invitation to participate in a clinical trial; 5% reported participation in a clinical trial. After adjustment younger age, receipt of chemotherapy or radiation, disease stage, and a more rational (versus more intuitive) decision-making style were associated with a higher odds of invitation to participate. Being married was associated with a higher odds of participation; having an annual family income ≥ $40,000 was associated with a lower odds of participation. 10% of patients reported invitation to participate in a clinical trial, and half of these reported participation. Invitation to participate varied by age and decision-making style, and participation varied by marital status and income.