Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT04248257
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.
Study:
NCT04248257
Study Brief:
Protocol Section:
NCT04248257