Abstract

Abstract 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 analysis showed that participants exposed to the intervention had significant higher awareness of clinical trials, particularly understanding their purpose and requirements, benefits and risks and their potential as an appropriate treatment for a serious disease, than participants in the usual care control group. In addition, patients in the intervention group showed significant changes between baseline and post intervention on stages of change compared to the control group. In the intervention group the percentage of women in preparation increased from 26.4% at baseline to 62.3% at post-intervention and the proportion of those in action rose from 35.8% to 67.9% at post-intervention. 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. The study is funded by the Susan G. Komen for the Cure (Award No. SAB08-00005) and the Cancer Therapy & Research Center (Grant No. P30 CA054174). This abstract was also presented as Poster A5. Citation Format: Patricia Chalela, Edgar Muñoz, Kipling J. Gallion, Anand Karnad, Amelie G. Ramirez. Empowering Latina breast cancer patients to make informed decisions about clinical trials: A multicommunication approach. [abstract]. In: Proceedings of the Seventh AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 9-12, 2014; San Antonio, TX. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2015;24(10 Suppl):Abstract nr PR06.

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