NCT06892275 · Georgetown University
The FYI on MRI: A Multilevel Decision Support Intervention for Screening Breast MRI
What this study is about
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 randomly assigned to (1) enhanced usual care (risk assessment + referral to nurse practitioner) or (2) decision support (enhanced usual care + decision aid).
View original scientific description
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.
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.
Primary outcome measures
Informed decisions about breast MRI
Time frame: 1 month
According to the Multidimensional Measure of Informed Choice, an informed decision is made with adequate knowledge and consistent with the respondent's preferences. Thus, two groups are classified as having made an informed decision: (1) those with adequate MRI knowledge, whose preferences align with screening with mammogram + MRI, and who intend to undergo MRI; and (2) those with adequate MRI knowledge, whose preferences align with screening with mammogram only, and who do not intend to undergo MRI. The knowledge, preferences, and intentions scores collected at T1 will be used to identify informed decisions.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Washington D.C., District of Columbia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 30, 2025 · Source of record for eligibility and locations