Community navigation intervention for social needs in patients with abnormal mammography: a randomized controlled trial study protocol.

Background: Effective follow-up care plays a critical role in enhancing breast cancer outcomes, as diagnosing breast cancer in earlier stages can improve mortality and ease treatment burden. Individuals with unmet social needs face greater barriers in completing their follow-up care (e.g., additional imaging, biopsies, and surgery). They are two times less likely to complete follow-up appointments. When patients do not complete follow-up appointments, they are at higher risk of detecting breast cancer at a later stage. We aim to examine how a social needs intervention via community navigation may (1) address patients' social needs, and (2) improve the completion of recommended medical care following an abnormal mammography.

Methods: This is a single-center randomized controlled trial taking place in the Intermountain West. We plan to enroll 1,450 participants throughout the study. Women with abnormal mammography results will be invited to complete a validated, 10-item social needs screening assessment in English or Spanish. Eligible patients will be at least 18 years of age, speak English or Spanish, and indicate at least one social need. Participants will be randomized to passive or active social needs categories. Those in the active group will be called by 211 United Way services (211), a service which connects callers to community resources. The passive group will not receive a call from 211. Instead, they will be provided with information to contact 211 independently if they choose to. Primary outcomes are: (1) change in social needs, and (2) follow-up of abnormal mammography results, and will be assessed through follow-up surveys and chart reviews. Interviews and focus group discussions will explore how social needs influence patients' adherence to recommended follow-up after an abnormal mammography result, and the role of community service navigation assistance in that follow-up.

Discussion: This study utilizes a 10-item social needs assessment and community navigation services to address social needs that prevent women from receiving timely follow-up after an abnormal mammogram screening. Our goal is to improve breast cancer follow-up outcomes for women with social needs.

Trial Registration: The study was pre-registered at ClinicalTrials.gov on March 12, 2024, under identifier NCT06305312.