Protocol for a Cluster Randomized Trial to Evaluate a Faith-Based Breast Cancer Screening Navigation Model

Abstract Background Breast cancer is the most diagnosed cancer among women in the United States. While rates of advanced-stage breast cancer have declined overall, incidence is rising among Korean American women. Advance-stage breast cancer is more frequent among Korean women compared to other Asian ethnic groups, largely attributed to low adherence to breast cancer screening. Church settings offer important opportunities for education as most Korean American women over age 50 regularly attend church services. The objective of this trial is to evaluate the efficacy of a culturally tailored intervention “Faith in Action!” on breast cancer screening adherence rates among Korean American women. Methods A parallel cluster randomized trial with staggered roll-out was designed to evaluate the efficacy of the “Faith in Action!” intervention, a church-based small group education and lay health navigator program, delivered by trained church members, on breast cancer screening among Korean American women (NCT05298605). The study was designed and, will be conducted in partnership with our center’s Community Outreach and Engagement (COE) which formed a Community Advisory Board. Twenty-four total Korean churches in Los Angeles will be randomized within blocks of 8 churches to either intervention or waitlist control conditions in a 1:1 ratio. Using a train-the-trainer approach, lay navigators from the Korean Church community nominated by church leadership will be trained by COE and certified to deliver the Faith in Action! intervention to study participants over a 6-month program period. Participants at churches randomized to the waitlist control group receive an educational presentation on physical activity and nutrition and, after 6-month follow-up, are invited to receive the Faith in Action! intervention. Eligible participants include women, ages 45–75 years, who: attend a participating church in Los Angeles County, do not have a breast cancer diagnosis, and did not receive a mammogram in the last 2 years. The primary outcome is adherence to breast cancer screening guidelines within 6 months from end of the intervention. Secondary outcomes include adherence to breast cancer screening within 1 year and knowledge on breast cancer screening. Discussion This study addresses a current need for developing and testing culturally tailored interventions to increase breast cancer screening adherence among Korean American women. Leveraging partnerships with faith-based organizations and delivering the intervention through trained lay health navigators, if found to be effective, has the potential to provide a scalable and sustainable strategy for increasing screening rates and ultimately improve health and well-being as well as reduce cancer-related disparities in this population. Trial registration NCT05298605, Date of Registration: March 17, 2022, ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT05298605