Peer Support For Young Adult Women With High Breast Cancer Risk

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2025

Interventions

  • Behavioral: PeACE
    • 3 session peer coaching intervention
  • Behavioral: Community peer coaching
    • Peer coaching provided by community organizations that support the HBOC community

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Cancer-related distress
    • Time Frame: 12 months
    • 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
  • Decisional conflict
    • Time Frame: 12 months
    • 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
  • Genetic counseling
    • Time Frame: 12 months
    • Genetic counseling uptake at 12 months gathered via self-report (for untested women); this is a binary yes/no question

Participating in This Clinical Trial

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

Gender Eligibility: All

Index carriers can be men and women; those taking part in peer coaching will be female.

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Georgetown University
  • Provider of Information About this Clinical Study
    • Sponsor

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