Clinical trial · Interventional
The FYI on MRI: A Multilevel Decision Support Intervention for Screening Breast MRI
NCT06892275CI-TRIAL-00095978recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm Female | — | UNRESOLVED | — |
| Early Detection of Cancer | — | UNRESOLVED | — |
| Hereditary Breast and Ovarian Cancer Syndrome | — | UNRESOLVED | — |
| Magnetic Resonance Imaging | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision Support | Behavioral | — | UNRESOLVED |
| Enhanced Usual Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Enhanced Usual Care
- description
- 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.
- interventionNames
- Behavioral: Enhanced Usual Care
- type
- EXPERIMENTAL
- label
- Decision Support
- description
- 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).
- interventionNames
- Behavioral: Enhanced Usual Care
- Behavioral: Decision Support
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDConley CC, Mills MG, Dash C, Luta G, Song JH, Isaacs C, Graves KD, O'Neill SC. The FYI on MRI: Protocol for a randomized, parallel-group superiority trial of a multilevel decision support intervention to increase informed decision-making about screening breast MRI among high-risk black and Latina women. Contemp Clin Trials. 2026 Aug 20;169:108442. doi: 10.1016/j.cct.2026.108442. Online ahead of print. PMID 42624429