The Preventive Risk Outreach And Cascade Testing

NCT07478237 | Not Yet Recruiting

• 1 other identifier: 82980
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Genetic Predisposition; Family Members

Keywords

Cascade genetic testing

Outcome Measures

Primary Outcomes (1)

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

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

  6 months

Secondary Outcomes (5)

• 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

Other Outcomes (4)

• Assess Relatives' appraisal of their decision making about genetic testing

  180 days +/- 90 days

• Relatives' confidence in their understanding of hereditary cancer risk

  180 days +/- 90 days

• Compare the proportion of eligible relatives who requested genetic testing in each study arm

  6 months

Study Arms (2)

PROACT Platform - Minimally Facilitated Testing

EXPERIMENTAL

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.

Other: Minimally facilitated platform

PROACT Platform - AI

EXPERIMENTAL

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.

Other: AI-powered platform

Interventions

Minimally facilitated platform OTHER

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

PROACT Platform - Minimally Facilitated Testing

AI-powered platform OTHER

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

PROACT Platform - AI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Unable to read and write English or Spanish.
• Age ≥ 18 years old.
• Resides in the United States.
• 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.

Sponsors & Collaborators

• Stanford University: lead
• University of Michigan: collaborator

MeSH Terms

Conditions

Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Allison Kurian, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Jennifer Lee Caswell-Jin, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Steven Katz, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Lawrence An, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Rios-Ventura

CONTACT

6507258762; proactprogram@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine (Oncology)

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share