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

NCT06892275 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-09-30

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • Georgetown University

    lead OTHER

Principal Investigators

  • Claire C. Conley, PhD · Georgetown University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06892275 on ClinicalTrials.gov