Actively Recruiting
The FYI on MRI: A Multilevel Decision Support Intervention for Screening Breast MRI
Led by Georgetown University · Updated on 2025-09-30
80
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the impact of a decision support program on informed choices about breast MRI screening among Black and Latina women at high risk for breast cancer. The study compares two groups of 80 participants: one receiving enhanced usual care, including risk assessment and nurse practitioner referral, and the other receiving this care plus an additional decision aid. The goal is to see if the decision support leads to more informed decisions regarding breast MRI use. Participants are randomly assigned to either enhanced usual care, which involves receiving a letter about their breast cancer risk and instructions to contact a nurse practitioner, or decision support, which adds a mailed or emailed decision aid. This aid explains two screening options: annual mammography alone or combined with annual breast MRI, detailing risks, benefits, costs, and access. Both English and Spanish speakers are included, with support available for Spanish speakers. Participants complete assessments at the start and one month after the intervention, either in person or by phone, to measure informed decision-making, satisfaction, and decisional conflict. Data from medical records and self-reports are collected and monitored throughout. The study includes reminders and flexible scheduling to encourage participation and uses a distress protocol to support participants emotionally if needed. The trial lasts about one month post-intervention for outcome measurement.
CONDITIONS
Brief Title
The FYI on MRI: A Multilevel Decision Support Intervention for Screening Breast MRI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Aged 18-74 years
- Self-identifying as Black and/or Latina
- No personal history of breast cancer
- English- or Spanish-speaking
- Received a mammogram with normal results in the last 12 months
- 20% or higher lifetime breast cancer risk per the NCI Breast Cancer Risk Assessment Tool (BCRAT)
You will not qualify if you...
- Age under 18 or 75 and older
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 1 month
Participants receive either enhanced usual care, which includes breast cancer risk assessment and a referral letter to a nurse practitioner, or decision support, which includes enhanced usual care plus a mailed decision aid to help make informed choices about breast MRI screening.
Baseline visit and 1 follow-up visit (in-person or via phone)
Trial Site Locations
Total: 1 location
1
Georgetown University
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
Research Team
C
Claire C. Conley, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here