Empowering Latina breast cancer patients to make informed decisions about clinical trials: a pilot study.

Minority representation in clinical trials is vital for researchers to assess differential effects in outcomes of therapies on biological and genetic characteristics among groups. This study assessed the effect of Choices, a bilingual multi-component intervention, on perceived understanding of clinical trials, agreement with stages of decision readiness and consideration of clinical trials as a treatment option, among Latina breast cancer patients. This randomized controlled pilot study compared Choices with a control condition providing general clinical trial information to eligible patients. Seventy-seven Latina breast cancer patients were randomly assigned to either Choices (n = 38) or the control (n = 39). Choices included three components: an educational interactive video, a low-literacy booklet, and care coordination by patient navigation (i.e., educational and psychosocial support, coordinating appointments, translating, interacting with the medical team). Choices was more effective than the control in improving perceived understanding of clinical trials (p = .033) and increasing consideration of clinical trials as a treatment option (p = .008). Additionally, intervention participants showed significant changes between baseline and post-intervention on agreement with stages of decision readiness statements (p < .002) than control participants (p > .05); the percentage of intervention women in agreement with preparation to action statements increased from 52.8% at baseline to 86.1% at post-intervention, and those in agreement with ready to action stages rose from 50.0% to 88.9%. Computer-based videos and care coordination provided by patient navigation-specifically tailored to Latinos-are effective strategies to successfully address awareness, and improved decision-making skills to make informed decisions about clinical trial participation.