NCT04248257

Brief 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
560

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
active not 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 Progress90%
Jul 2020Dec 2026

First Submitted

Initial submission to the registry

January 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5.8 years

First QC Date

January 27, 2020

Last Update Submit

April 9, 2026

Conditions

Breast Cancer Risk

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

PeACE peer coaching arm

EXPERIMENTAL

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

Community peer coaching arm

ACTIVE COMPARATOR

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

Interventions

PeACEBEHAVIORAL

3 session peer coaching intervention

PeACE peer coaching arm
Community peer coachingBEHAVIORAL

Peer coaching provided by community organizations that support the HBOC community

Community peer coaching arm

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsIndex carriers can be men and women; those taking part in peer coaching will be female.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Georgetown University

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

Location

Dana Farber Cancer Center

Boston, Massachusetts, 02215, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07061, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10022, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9020, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Study Officials

  • Suzanne O'Neill

    Georgetown University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 27, 2020

First Posted

January 30, 2020

Study Start

July 15, 2020

Primary Completion

April 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

US(6)