NCT06892275

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Jun 2025Dec 2027

First Submitted

Initial submission to the registry

March 11, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

March 11, 2025

Last Update Submit

September 26, 2025

Conditions

Breast Neoplasm FemaleEarly Detection of CancerHereditary Breast and Ovarian Cancer SyndromeMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • Informed decisions about breast MRI

    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.

    1 month

Secondary Outcomes (2)

  • Decision Satisfaction

    1 month

  • Decisional Conflict

    1 month

Other Outcomes (7)

  • MRI Knowledge

    1 month

  • Screening Preferences

    1 month

  • Screening Intentions

    1 month

  • +4 more other outcomes

Study Arms (2)

Enhanced Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Usual Care

Decision Support

EXPERIMENTAL

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).

Behavioral: Enhanced Usual CareBehavioral: Decision Support

Interventions

Enhanced Usual CareBEHAVIORAL

Risk assessment and notification, referral to nurse practitioner (NP) at the Ralph Lauren Center (RLC)

Decision SupportEnhanced Usual Care
Decision SupportBEHAVIORAL

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.

Decision Support

Eligibility Criteria

Age18 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • aged \<18 or ≥75
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplastic Syndromes, HereditaryOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Claire C. Conley, PhD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire C. Conley, PhD

CONTACT

2026875086claire.conley@georgetown.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 24, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Locations

US(1)