Recruiting

Decision Support

Sponsor:

Georgetown University

Code:

NCT06892275

Conditions

Breast Neoplasm Female

Early Detection of Cancer

Hereditary Breast and Ovarian Cancer Syndrome

Magnetic Resonance Imaging

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Enhanced Usual Care

Decision Support

Study Details

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.

Conditions

Breast Neoplasm Female

Early Detection of Cancer

Hereditary Breast and Ovarian Cancer Syndrome

Magnetic Resonance Imaging

Study ID

NCT06892275

Start date

Jun 1, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: Enhanced Usual Care

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.

experimental: Decision Support

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).

Interventions

Enhanced Usual Care

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

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 measure

  • Informed decisions about breast MRI [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Claire C. Conley, PhD

2026875086claire.conley@georgetown.edu

Locations

Georgetown University

Recruiting

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

Contacts

Claire C. Conley, PhD

202-687-5086claire.conley@georgetown.edu

Principal Investigator:

Claire C. Conley, PhD

More Information

Sponsor

Georgetown University

Last update posted

Sep 30, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2025-09-30.