Active — Not RecruitingNot Applicable

Peer Support For Young Adult Women With High Breast Cancer Risk

United States560 participantsStarted 2020-07-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Cancer-related distress

Timeframe: 12 months

Decisional conflict

Timeframe: 12 months

Genetic counseling

Timeframe: 12 months

Trial details

NCT IDNCT04248257

SponsorGeorgetown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

View on ClinicalTrials.gov More Breast Cancer Risk trials