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

Purpose

: 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.

Methods

: 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.

Results

: 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.

Conclusions

: 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.