Recruiting

The FYI on MRI: A Multilevel Decision Support Intervention for Screening Breast MRI

The purpose of this study is to test the impact of a multilevel decision support intervention on informed decisions about breast MRI among high-risk Black and Latina women. Participants (N=80) will be randomized to (1) enhanced usual care (risk assessment + referral to nurse practitioner) or (2) decision support (enhanced usual care + decision aid). Assessments will take place at baseline (T0) and 1-month post-intervention (T1). The primary outcome is informed decisions about breast MRI at T1.

ClinicalTrials.gov IDNCT06892275

PhaseNA

Enrollment80

SponsorGeorgetown University

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Neoplasm Female, Early Detection of Cancer, Hereditary Breast and Ovarian Cancer Syndrome, Magnetic Resonance Imaging

About this study

Interventions

Behavioral: Enhanced Usual Care — Risk assessment and notification, referral to nurse practitioner (NP) at the Ralph Lauren Center (RLC)
Behavioral: Decision Support — The decision aid describes two different breast cancer screening plans: (1) annual mammography only; and (2) annual mammography plus annual breast MRI. The decision aid provides balanced information about breast MRI, including its risks, limitations, and benefits.

Primary outcomes

Informed decisions about breast MRI (1 month)

Eligibility information

Inclusion Criteria: * female * aged 18-74 years * self-identifying as Black and/or Latina * no personal history of breast cancer * English- or Spanish-speaking * having received a mammogram with normal results in the last 12 months * ≥20% lifetime breast cancer risk per the NCI Breast Cancer Risk Assessment Tool (BCRAT) Exclusion Criteria: * aged \<18 or ≥75 * pregnancy

Study locations

Georgetown University, Washington D.C., District of Columbia 20007 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.