跳至主要内容
临床试验/NCT04248257
NCT04248257已完成不适用

Peer Support For Young Adult Women With High Breast Cancer Risk

Georgetown University11 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2020年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
320
试验地点
11
主要终点
Genetic counseling

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.
  • Female 1st-, 2nd- or 3rd-degree biological relatives of index carriers aged 21-30.

排除标准

  • Must be able to speak English or Spanish and provide informed consent

研究组 & 干预措施

PeACE peer coaching arm

Experimental

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.

干预措施: PeACE (Behavioral)

Community peer coaching arm

Active Comparator

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.

干预措施: Community peer coaching (Behavioral)

结局指标

主要结局

Genetic counseling

时间窗: 12 months

Genetic counseling uptake at 12 months gathered via self-report (for untested women); this is a binary yes/no question

Decisional conflict

时间窗: 12 months

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

Cancer-related distress

时间窗: 12 months

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (11)

Loading locations...

相似试验