The Preventive Risk Outreach and Cascade Testing (PROACT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Proportion of all eligible first- and second-degree relatives who undergo genetic testing through Color Health in each study arm
研究概览
简要总结
The goal of this clinical trial is to learn whether a new online program developed by the research team is able to help families learn about family cancer risk and how to reduce this risk, as well as help interested family members get low-cost, at-home genetic testing for cancer risk.
详细描述
The overarching goal of this study is to facilitate cascade genetic testing to reduce the burden of cancer in families with hereditary cancer syndromes (HCS). We will evaluate different versions of a point-of-care cascade genetic testing referral service for probands with recently detected pathogenic or likely pathogenic genetic variants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- 是
入选标准
- •Age ≥ 18 years old.
- •Known to carry a pathogenic or likely pathogenic variant in a gene included in the 2024 current Color Health Cancer Panel Test.
- •Have at least one (1) first- or second-degree relative who is living in the United States and has not yet had germline genetic testing.
排除标准
- •1. Unable to read and write English or Spanish.
- •Inclusion Criteria - Relatives
- •Age ≥ 18 years old.
- •Resides in the United States.
- •Exclusion Criteria - Relatives
- •Completed genetic testing by a clinician within the last 5 years that included the pathogenic or likely pathogenic variant.
- •Not a first- or second-degree relative of the proband.
研究组 & 干预措施
PROACT Platform - Minimally Facilitated Testing
The Minimally Facilitated testing arm is a simplified version of the PROACT-AI platform, that provides participants with access to low-cost testing only, in addition to standard of care.
干预措施: Minimally facilitated platform (Other)
PROACT Platform - AI
The AI-powered arm will provide participants access to low-cost testing via an AI-powered platform as well as provide additional features including genetic education, motivational interviewing, family communication, and complete follow-up surveys.
干预措施: AI-powered platform (Other)
结局指标
主要结局
Proportion of all eligible first- and second-degree relatives who undergo genetic testing through Color Health in each study arm
时间窗: 6 months
Proportion of all eligible first- and second-degree relatives who undergo genetic testing through Color Health in each study arm
次要结局
- Proportion of eligible first-degree relatives who undergo genetic testing through Color Health in each study arm(6 months)
- Proportion of index patients for whom at least one eligible relative undergoes genetic testing through Color Health in each study arm(6 months)
- Proportion of eligible relatives invited by the patient in each study arm(180 days)
- Proportion of eligible relatives who join the PROACT program in each study arm(28 days)
- Proportion of relatives who completed the genetic risk education modules as measured by platform paradata [PROACT platform-AI Arm Only](180 days)
研究者
Jennifer Lee Caswell-Jin
Assistant Professor of Medicine (Oncology)
Stanford University