Peer Support For Young Adult Women With High Breast Cancer Risk

Georgetown University

Status: Enrolling

Conditions: Breast Cancer Risk

Treatments: Behavioral: PeACE; Behavioral: Community peer coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT04248257

STUDY00001007

Details and patient eligibility

About

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.

Enrollment: 560 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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560 participants in 2 patient groups

PeACE peer coaching arm

Experimental group

Description:

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.

Treatment:

Behavioral: PeACE

Community peer coaching arm

Active Comparator group

Description:

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.

Treatment:

Behavioral: Community peer coaching