The Preventive Risk Outreach And Cascade Testing

Официальное название

The Preventive Risk Outreach and Cascade Testing (PROACT)

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Minimally facilitated platform
  This group will receive access to low-cost genetic testing via an email link and an access code.
• Другое AI-powered platform
  This group will receive access to low-cost genetic testing via an AI-powered platform that will also provide genetic education, motivational interviewing, and family communication

Первичные конечные точки

• Proportion of all eligible first- and second-degree relatives who undergo genetic testing through Color Health in each study arm [Срок оценки: 6 months]

Вторичные конечные точки (5)

• Proportion of eligible first-degree relatives who undergo genetic testing through Color Health in each study arm [Срок оценки: 6 months]
• Proportion of index patients for whom at least one eligible relative undergoes genetic testing through Color Health in each study arm [Срок оценки: 6 months]
• Proportion of eligible relatives invited by the patient in each study arm [Срок оценки: 180 days]
• Proportion of eligible relatives who join the PROACT program in each study arm [Срок оценки: 28 days]
• Proportion of relatives who completed the genetic risk education modules as measured by platform paradata [PROACT platform-AI Arm Only] [Срок оценки: 180 days]

Критерии участия

Inclusion Criteria - Probands

• 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.

Exclusion Criteria - Probands

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07478237 · 82980

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗