FYI on MRI: decision support to help high-risk Black and Latina women decide about screening breast MRI
The FYI on MRI: A Multilevel Decision Support Intervention for Screening Breast MRI
This project will test whether adding a decision aid to risk assessment and nurse referral helps high-risk Black and Latina women make informed choices about screening breast MRI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | Female |
| Sponsor | Georgetown University Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06892275 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 80 Black and Latina women at high lifetime risk (≥20%) for breast cancer and randomize them to enhanced usual care (risk assessment plus nurse practitioner referral) or decision support (enhanced usual care plus a decision aid). Assessments occur at baseline and one month after the intervention, with the primary outcome defined as an informed decision about breast MRI—sufficient knowledge aligned with personal preferences. The intervention is delivered through a community-based clinic affiliated with Georgetown Lombardi's Ralph Lauren Center, and materials are available in English and Spanish. The trial follows established behavioral intervention design and reporting standards to protect participants and measure outcomes rigorously.
Who should consider this trial
Good fit: Black or Latina women aged 18–74 without a personal history of breast cancer, English- or Spanish-speaking, with a normal mammogram within 12 months and ≥20% lifetime breast cancer risk per the NCI BCRAT are ideal candidates.
Not a fit: Women who are pregnant, outside the 18–74 age range, have a prior breast cancer diagnosis, or have less than a 20% lifetime risk are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could increase the number of high-risk Black and Latina women who choose screening MRI based on clear information and their own preferences.
How similar studies have performed: Decision aids have improved informed decision-making in other screening contexts, but multilevel decision support specifically for screening breast MRI in high-risk Black and Latina women is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Washington D.C., District of Columbia
- Georgetown University — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Claire C. Conley, PhD — Georgetown University
- Study coordinator: Claire C. Conley, PhD
- Email: claire.conley@georgetown.edu
- Phone: 2026875086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.