Peer Support For Young Adult Women With High Breast Cancer Risk

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Risk
• Intervention / Treatment: Behavioral: PeACE; Behavioral: Community peer coaching

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Georgetown University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07061
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10022
      • Memorial Sloan Kettering Cancer Center
  • Texas
    • Dallas, Texas, United States, 75390-9020
      • University of Texas Southwestern Medical Center
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 multiplex panel genetic testing. Index carriers will have received testing.

YARs:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PeACE peer coaching arm; Behavioral, PeACE, PeACE consists of 3 streamlined 30-minute psychosocial telephone counseling sessions delivered by a well-trained peer coach. Coaches are lay YARs from HBOC families demonstrating good knowledge, communication skills, and protocol mastery.	Behavioral: PeACE; 3 session peer coaching intervention
Active Comparator: Community peer coaching arm; Behavioral, usual care, Participants in the usual care arm will receive navigation to peer support with a range of community groups who provide these services.	Behavioral: Community peer coaching; Peer coaching provided by community organizations that support the HBOC community

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer-related distress	Cancer-related distress about hereditary breast and ovarian cancer risk at 12 months, gathered via self-report using the Impact of Events Scale, a 15 item measure scored on a 0-3 scale (0-45) with higher scores meaning higher distress	12 months
Decisional conflict	Decisional conflict about hereditary breast and ovarian cancer risk management decisions at 12 months gathered via self-report using the Decisional Conflict Scale. The 16 items on a 0-4 scale are summed, divided by 16 and multiplied by 25 for a total score (range=0-100); higher scores indicate higher conflict	12 months
Genetic counseling	Genetic counseling uptake at 12 months gathered via self-report (for untested women); this is a binary yes/no question	12 months

Collaborators and Investigators

• Sponsor: Georgetown University
• Investigators: Principal Investigator: Suzanne O'Neill, Georgetown University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): April 17, 2026
• Study Completion (Actual): April 17, 2026

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: STUDY00001007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No