Clinical trial NCT04248257: Peer Support For Young Adult Women With High Breast Cancer Risk
Official title: Peer Support For Young Adult Women With High Breast Cancer Risk
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Risk
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Germline (e.g., BRCA) mutation carriers have highly elevated odds of developing hereditary breast-ovarian cancer (HBOC), as could their relatives. Referral to genetic counseling is the standard of care for young, at-risk adult relatives (i.e., ages 18-39; herein "YARs"). However, many female YARs struggle to make decisions about familial HBOC risk management, including whether and when to pursue genetic counseling, how to cope with stress and uncertainty about HBOC, and how to navigate lifecycle events entwined with HBOC threats (e.g., childbearing). Prior work points to YARs' strong desires to seek HBOC risk information and emotional support beyond traditional genetic counseling-especially support from knowledgeable peers who can relate to their experiences and offer neutral grounding and objective guidance about coping strategies. Peer support is a promising psychosocial cancer care approach that could fill this void. However, few evidence-based standards inform its practice as an adjunct to cancer genetic counseling. As genetic testing for HBOC risk expands population-wide, new ways must be tested to reach, educate, and support YARs to further reduce the cancer burden in communities of at-risk women. The 2-arm PeACE trial includes streamlined telephone counseling delivered by well-trained community peer coaches, with session content incorporating coping training for HBOC stress reduction, and decision making and problem solving training about genetic counseling and HBOC risk. Trial participants are female YARs (aged 21-30) randomized to an intervention or equated control condition, and followed for up to 12 months.

Eligibility criteria: 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

Primary outcomes:
measure: Cancer-related distress
timeFrame: 12 months
measure: Decisional conflict
timeFrame: 12 months
measure: Genetic counseling
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Boston
country: United States
facility: Dana Farber Cancer Center
state: Massachusetts
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Georgetown University
name: Suzanne O'Neill
role: PRINCIPAL_INVESTIGATOR
References: