Empowering Latinas to make informed decisions about breast cancer clinical trials

Background: Without adequate minority representation in clinical trials, researchers cannot assess differential effects in outcomes or ensure the safety of therapies across a range of biological and genetic characteristics among groups, nor can they ensure generalizability of trial results. In response, this theory-based educational intervention aims to empower Latinas to make informed decisions about breast cancer clinical trials (BCCTs) by enhancing their knowledge, attitudes, skills and self-efficacy required to support discussion of BCCTs as a treatment option with doctors and family members. Methods: This is a cohort study with random assignment of 112 Latina breast cancer patients eligible to participate in a BCCT at the Cancer Therapy & Research Center at the University of Texas Health Science Center at San Antonio. The intervention includes: participation in a culturally sensitive, individually tailored, computer-based BCCTs video; a bilingual, low-literacy booklet; and assistance from a patient navigator. The control includes usual care clinical trial information materials for eligible patients. Results: Preliminary results will be presented. The authors hypothesize that intervention participants will have higher self-efficacy to make a decision about participating in a BCCT and will demonstrate higher self-efficacy expectations and confidence in the system for making a decision about participating in a BCCT trial than participants in the usual care control group. Conclusion: Computer-based videos—if specifically tailored to Latinos—may be a cost-effective strategy to effectively address awareness, cultural and attitudinal barriers and decision making skills needed to make informed decisions about clinical trial participation.