The FOR ME (Fostering Opportunities in Research through Messaging and Education) study: Developing a culturally sensitive narrative intervention to promote equity in clinical trials.

TPS6653 Background: Black women are more likely to die from breast cancer than women of any other race/ethnicity. Contributing factors to this inequity include structural and socioeconomic determinants of health, differential access to novel therapies, tumor biology and comorbidities. 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 clinical trials is a contributing factor to health disparities. The first aim of this study is to conduct multiple qualitative methods with multi-level stakeholders to identify barriers, facilitators, and intervention priorities that would assist Black breast cancer patients to make informed decisions about participating in clinical trials. Secondly, we aim to create a culturally sensitive, narrative intervention designed to support decision making and motivate Black breast cancer patients to participate in clinical trials. Aim 3 will pilot a study to determine acceptability of the intervention among patients and assess whether it increases clinical trial participation in a safety net oncology practice. Methods: Community-based participatory research approaches are guiding our research methodologies. First, we are conducting interviews and story circles with Black women with breast cancer, community partners and advocates, and oncologists and clinical trials office staff. These interviews will identify themes to inform intervention content. Next, interviews and focus groups will invite feedback on the educational/motivational content of the intervention and will be used to develop a culturally sensitive script and storyboards. A video production company will produce the narrative intervention. Finally, focus groups and interviews with participant cohorts will provide feedback on the completed intervention. Black women diagnosed with breast cancer will view the intervention in an oncology clinic. Using a pretest/posttest design, we will analyze the 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 trial participation among Black breast cancer patients increases following implementation of the intervention as a standard component of new patient education. Recruitment started in July 2022, and currently, 14 of 30 interviews with patients are completed. Aim 1 interviews with patients, oncologists, clinical trial staff, and advocates are expected to finish by April 2023, and results will be presented.