The Preventive Risk Outreach And Cascade Testing

N/ANot Yet RecruitingNCT07478237

Stanford University400 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

400

Conditions

Genetic Predisposition Family Members

Interventions

Minimally facilitated platformOTHER

This group will receive access to low-cost genetic testing via an email link and an access code.

AI-powered platformOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria - Probands 1. Age ≥ 18 years old. 2. Known to carry a pathogenic or likely pathogenic variant in a gene included in the 2024 current Color Health Cancer Panel Test. 3. 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 1. Age ≥ 18 years old. 2. Resides in the United States. Exclusion Criteria - Relatives 1. Completed genetic testing by a clinician within the last 5 years that included the pathogenic or likely pathogenic variant. 2. Not a first- or second-degree relative of the proband.

Outcomes

Primary Outcomes

Proportion of all eligible first- and second-degree relatives who undergo genetic testing through Color Health in each study arm

Time frame: 6 months

Secondary Outcomes

Proportion of eligible first-degree relatives who undergo genetic testing through Color Health in each study arm

Time frame: 6 months

Proportion of index patients for whom at least one eligible relative undergoes genetic testing through Color Health in each study arm

Time frame: 6 months

Proportion of eligible relatives invited by the patient in each study arm

Time frame: 180 days

Proportion of eligible relatives who join the PROACT program in each study arm

Time frame: 28 days

Proportion of relatives who completed the genetic risk education modules as measured by platform paradata [PROACT platform-AI Arm Only]

Proportion of relatives who completed the genetic risk education modules as measured by platform paradata \[PROACT platform-AI Arm Only\]

Time frame: 180 days

Central Contacts

Sonia Rios-Ventura

CONTACT

6507258762 proactprogram@stanford.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.