Peer Support For Young Adult Women With High Breast Cancer Risk

Study Overview
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Brief Summary
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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.

Official Title
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Peer Support For Young Adult Women With High Breast Cancer Risk

Conditions
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Breast Cancer Risk

Intervention / Treatment
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* Behavioral: PeACE
* Behavioral: Community peer coaching


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PeACE peer coaching arm<br>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<br>* 3 session peer coaching intervention<br>|
| Active Comparator: Community peer coaching arm<br>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<br>* Peer coaching provided by community organizations that support the HBOC community<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |