Abstract B062: Optimizing the PRE-ACT educational intervention to promote decision making about clinical trials among racial and ethnic minorities: The role of the research navigator
Authors: Zhang Annie L. , Vinson Valerie , Hoy Kevin C. , Uy Violeta , Austin Kristina , Trapl Erika , Shoag Jamie , Bruno Debora 
Published: January 2023

Background Representation in clinical trials that reflects the growing racial/ethnic population diversity in United States is a matter of health equity. Barriers to participation are multifactorial, ranging from awareness of trials, opportunity to participate, and decision making. PRE-ACT is a web-based patient tailored educational tool, previously demonstrated in a randomized controlled trial to improve knowledge and decrease attitudinal barriers to clinical trials participation. However, PRE-ACT enrolled a predominantly white population and subgroup analysis did not show benefit among the non-white participants. The primary objective of this intervention is to improve preparation for consideration of clinical trials using tailored, patient-specific information to address barriers related to knowledge and attitudes among racial/ethnic minority cancer patients (pts). This intervention will adapt the PRE-ACT model to racial/ethnic minorities at a large hybrid academic-community practice healthcare organization (HCO) and incorporate the use of research navigators. Methods This is a prospective interventional cohort study. After IRB approval, eligible pts will be recruited from medical oncology clinics throughout the HCO, including community clinics. They must be 18 or older, have a diagnosis of cancer undergoing oncological work-up, treatment, or surveillance, self-identify with a non-white race or Hispanic ethnicity, and have a life expectancy &gt;3 months. Self-administered surveys will collect demographics and socioeconomic status indicators. Clinical data will be obtained by chart review. A survey will assess knowledge and attitudes towards clinical trials, being administered before and after the intervention. Intervention will consist of research navigator-facilitated 30-minute tailored educational encounter including short videos and discussion based on pts’ responses from the pre-intervention survey. The primary outcome is change in knowledge and attitudes after the intervention. Secondary outcomes are clinical trials participation rates after intervention, compared to historical trends at the HCO. Chi-square test will be used for pre-post comparison using the composite posttest results as observed values and the composite pretest results as expected values; a threshold of 0.05 will be used to determine significant difference. Results This protocol is undergoing review with implementation predicted for the fall of 2022. We expect to accrue 600 patients over the span of 4 years. Conclusions Novel strategies are needed to improve access to clinical trials among racial/ethnic minorities. Understanding and addressing knowledge and attitudes towards clinical trials participation is a key step in this process. We describe a proposed adaptation to the PRE-ACT model utilizing a research navigator framework to address knowledge and attitudinal barriers to participation in clinical trials among minority patients at a large HCO.

Citation Format: Annie L. Zhang, Valerie Vinson, Kevin C. Hoy Jr., Violeta Uy, Kristina Austin, Erika Trapl, Jamie Shoag, Debora Bruno. Optimizing the PRE-ACT educational intervention to promote decision making about clinical trials among racial and ethnic minorities: The role of the research navigator [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 B062.