Peer Support For Young Adult Women With High Breast Cancer Risk

Breast Cancer Risk Clinical Trial

Official title:

Peer Support For Young Adult Women With High Breast Cancer Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04248257
• Other study ID #: STUDY00001007
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: December 2025

Study information

• Verified date: April 2023
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Risk
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Dana Farber Cancer Center	Boston	Massachusetts
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Washington	Seattle	Washington
United States	Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Genetic counseling	Genetic counseling uptake at 12 months gathered via self-report (for untested women); this is a binary yes/no question	12 months