Peer Support For Young Adult Women With High Breast Cancer Risk

Last updated: November 12, 2025
Sponsor: Georgetown University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Community peer coaching

PeACE

Clinical Study ID

NCT04248257
STUDY00001007
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This trial will recruit young adult female relatives (YARs) of male or female carriers of BRCA1/2. YARs who consent to participate will be randomized to either a 3-session peer coach-led telephone counseling intervention or usual care navigation to peer support interventions provided by community organizations that support the hereditary cancer community. Study aims are to 1) Assess intervention effects on distress and decision making outcomes, including uptake of counseling for untested YARs, 2) Identify YARs most likely to engage with and benefit from the intervention, 3) Understand intervention mechanisms. Participants will complete interviews at baseline, 1, 6, and 12 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • There are two targets for recruitment with different eligibility criteria.

Index carriers:

  • Men or women aged 18 or older with BRCA mutations with or without 2nd-tier multiplexpanel genetic testing. Index carriers will have received testing.

YARs:

  • Female 1st-, 2nd- or 3rd-degree biological relatives of index carriers aged 21-30.

Exclusion

Exclusion Criteria:

  • Must be able to speak English or Spanish and provide informed consent

Study Design

Total Participants: 560
Treatment Group(s): 2
Primary Treatment: Community peer coaching
Phase:
Study Start date:
July 15, 2020
Estimated Completion Date:
December 31, 2026

Study Description

Germline (e.g., BRCA) mutation carriers have highly elevated odds of developing hereditary breast-ovarian cancer (HBOC), as could their relatives. Referral to genetic counseling is the standard of care for young, at-risk adult relatives (i.e., ages 18-39; herein "YARs"). However, many female YARs struggle to make decisions about familial HBOC risk management, including whether and when to pursue genetic counseling, how to cope with stress and uncertainty about HBOC, and how to navigate lifecycle events entwined with HBOC threats (e.g., childbearing). Prior work points to YARs' strong desires to seek HBOC risk information and emotional support beyond traditional genetic counseling-especially support from knowledgeable peers who can relate to their experiences and offer neutral grounding and objective guidance about coping strategies. Peer support is a promising psychosocial cancer care approach that could fill this void. However, few evidence-based standards inform its practice as an adjunct to cancer genetic counseling. As genetic testing for HBOC risk expands population-wide, new ways must be tested to reach, educate, and support YARs to further reduce the cancer burden in communities of at-risk women. The 2-arm PeACE trial includes streamlined telephone counseling delivered by well-trained community peer coaches, with session content incorporating coping training for HBOC stress reduction, and decision making and problem solving training about genetic counseling and HBOC risk. Trial participants are female YARs (aged 21-30) randomized to an intervention or equated control condition, and followed for up to 12 months.

Connect with a study center

  • Georgetown University

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Georgetown University

    Washington D.C. 4140963, District of Columbia 4138106 20007
    United States

    Site Not Available

  • Dana Farber Cancer Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07061
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack 5098706, New Jersey 5101760 07061
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10022
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10022
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390-9020
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390-9020
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98109
    United States

    Site Not Available

  • University of Washington

    Seattle 5809844, Washington 5815135 98109
    United States

    Site Not Available

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