RecruitingNot ApplicableNCT06892275

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

Sponsor

Georgetown University

Enrollment

80 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a decision-support tool designed to help Black and Latina women who are at higher-than-average risk for breast cancer decide whether to get a screening breast MRI in addition to their regular mammogram. The tool aims to improve informed decision-making about a more sensitive but less commonly used screening method. **You may be eligible if...** - You are a woman aged 18–74 - You identify as Black and/or Latina - You have no personal history of breast cancer - You have had a normal mammogram in the last 12 months - You have a lifetime breast cancer risk of 20% or higher according to a standard risk calculator - You speak English or Spanish **You may NOT be eligible if...** - You are under 18 or 75 years and older - You are currently pregnant - You have previously been diagnosed with breast cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALEnhanced Usual Care

Risk assessment and notification, referral to nurse practitioner (NP) at the Ralph Lauren Center (RLC)

BEHAVIORALDecision 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.