Abstract
Abstract Background: Black women are more likely to die from breast cancer than women from any other race/ethnicity. Contributing factors to this inequity include tumor biology, comorbidities, socioeconomic determinants such as poverty, culture, and social injustice, and differential access to and utilization of novel therapies. In 2020, only 7.2% of enrollees in clinical trials that led to approval of 3 novel drugs for breast cancer were Black. Underrepresentation of patients from racial/ethnic minority groups in cancer clinical trials is a barrier to achieving health equity and results in a lack of scientific advancement and comprehensive understanding of the safety, efficacy, effectiveness, and biological heterogeneity of treatment effect. Objective: To develop, optimize and pilot test a narrative decision aid intervention (web-based video) that is culturally sensitive, grounded in a multi-level theoretical framework, and informed by in-depth qualitative research that can be implemented in safety net oncology practices and will support decision making among Black breast cancer patients related to clinical trial participation. Specific Aims: Aim 1) Conduct multiple qualitative methods with multi-level stakeholders to identify barriers, facilitating factors and intervention priorities to support decision making and motivate Black breast cancer patients to participate in clinical trials. Aim 2) Create a culturally-sensitive, narrative intervention designed to support decision making and motivate Black breast cancer patients to participate in clinical trials. Aim 3) Determine acceptability among patients and conduct a pilot study to determine whether the intervention increases clinical trials participation in a safety net oncology practice. Study Design: Interviews with members of the target audience, community partners, oncologists, and clinical trials office staff from a safety net hospital will identify salient themes to inform intervention content. Community-based participatory research approaches will guide research methodology. Interviews, focus groups, and story circles with participant cohorts will elicit input and feedback on the educational/motivational content informed by qualitative data and will be used to develop a script and storyboards that are culturally sensitive. A video production company will produce the narrative intervention. Focus groups and interviews with participant cohorts will provide iterative feedback on the completed intervention. Black patients currently diagnosed with breast cancer will view the intervention in an Oncology clinic. Using a pretest/posttest design, we will analyze acceptability of the intervention and its effect on intention to participate in clinical trials. We will then conduct a quasi-experimental study in a safety net oncology practice to determine whether the rate of clinical trials participation among Black breast cancer patients increases following implementation of the intervention as a standard component of new patient education. Study recruitment will begin July 2022. Citation Format: Vida Henderson, Leslie Carnahan, Ryan Nguyen, Pam Khosla, AnneMarie Murphy, Beulah Brent, Kent Hoskins. The For Me (Fostering Opportunities in Research through Messaging and Education) study: Developing a culturally sensitive narrative intervention to promote equity in clinical trials [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B047.
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