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

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

Inclusion Criteria7

  • 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 Criteria2

  • aged \<18 or ≥75
  • pregnancy

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.


Locations(1)

Georgetown University

Washington D.C., District of Columbia, United States

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NCT06892275


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