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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT06892275
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Enhanced Usual Care — BEHAVIORAL
    Risk assessment and notification, referral to nurse practitioner (NP) at the Ralph Lauren Center (RLC)
  • Decision Support — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Active Comparator: Enhanced Usual Care
    Participants in this arm will be mailed a letter with their estimated lifetime risk for breast cancer per the NCI Breast Cancer Risk Assessment Tool (BCRAT), information about screening breast MRI, and instructions for contacting the nurse practitioner (NP) at the Ralph Lauren Center (RLC) with questions.
  • Experimental: Decision Support
    Participants in this arm will receive the same letter as those in the Enhanced Usual Care arm. In addition, they will be sent the decision aid via mail or email (as preferred).

Primary Outcome Measure

Informed decisions about breast MRI [ Time Frame: 1 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Georgetown UniversityWashington D.C.District of Columbia20007
Claire C. Conley, PhD
[email protected]
202-687-5086
Claire C. Conley, PhD (PRINCIPAL_INVESTIGATOR)

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