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NCT Number: NCT07478237

The Preventive Risk Outreach And Cascade Testing

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.

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Key information

Conditions

Genetic Predisposition Disease Attributes Disease Susceptibility Family Members Genetic Predisposition to Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Minimally facilitated platform

Other

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

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

Primary outcomes

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

    Time frame: 6 months

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

Secondary outcomes

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

    Time frame: 6 months

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

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

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

    Time frame: 180 days

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

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

    Time frame: 28 days

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

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

    Time frame: 180 days

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

Other outcomes

  1. Assess Relatives' appraisal of their decision making about genetic testing

    Time frame: 180 days +/- 90 days

    Assess Relatives' appraisal of their decision making about genetic testing, as measured by the Decision Quality Scale. The minimum value for the Decision Quality Scale is 7, and the maximum value is 35. A higher score on this scale indicates a better outcome, i.e. a higher score reflects a more positive appraisal of PROACT by relatives regarding their decision-making about genetic testing.

  2. Relatives' confidence in their understanding of hereditary cancer risk

    Time frame: 180 days +/- 90 days

    To compare enrolled relatives' confidence in their understanding of hereditary cancer risk, using interviews.

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

    Time frame: 6 months

    Using survey responses, compare the proportion of eligible relatives who requested genetic testing within 6 months of enrollment in each study arm, as measured by survey responses.

  4. Assess Index patients' appraisal of communication with their relatives

    Time frame: 180 days +/- 90 days

    Assess Index patients' appraisal of communication with their relatives, as measured by a modified Patient Assessment of Family Communication Scale. The minimum value of the scale is 10, and the maximum value is 50. A higher score, controlling for baseline, indicates a greater improvement in the patient's assessment of their communication with relatives.

Study contacts

Contact information is provided by the study sponsor or research team.

Sonia Rios-Ventura

CONTACT

[email protected]

6507258762

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • University of Michigan

Registry information

Official study title

The Preventive Risk Outreach and Cascade Testing (PROACT)

Acronym: PROACT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 17, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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