The Preventive Risk Outreach And Cascade Testing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Probands
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Minimally facilitated platform
Other interventionThis group will receive access to low-cost genetic testing via an email link and an access code.
AI-powered platform
Other interventionThis 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
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: PROACT Platform - Minimally Facilitated TestingExperimental treatment 1 intervention
Group B: PROACT Platform - AIExperimental treatment 1 intervention
Trial outcomes
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
Time frame
6 monthsSecondary outcomes
1
Proportion of eligible first-degree relatives who undergo genetic testing through Color Health in each study arm
Proportion of eligible first-degree relatives who undergo genetic testing through Color Health in each study arm
Time frame
6 months2
Proportion of index patients for whom at least one eligible relative undergoes genetic testing through Color Health in each study arm
Proportion of index patients for whom at least one eligible relative undergoes genetic testing through Color Health in each study arm
Time frame
6 months3
Proportion of eligible relatives invited by the patient in each study arm
Proportion of eligible relatives invited by the patient in each study arm
Time frame
180 days4
Proportion of eligible relatives who join the PROACT program in each study arm
Proportion of eligible relatives who join the PROACT program in each study arm
Time frame
28 daysOther outcomes
1
Assess Relatives' appraisal of their decision making about genetic testing
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.
Time frame
180 days +/- 90 days2
Relatives' confidence in their understanding of hereditary cancer risk
To compare enrolled relatives' confidence in their understanding of hereditary cancer risk, using interviews.
Time frame
180 days +/- 90 days3
Compare the proportion of eligible relatives who requested genetic testing in each study arm
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.
Time frame
6 months4
Assess Index patients' appraisal of communication with their relatives
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.
Time frame
180 days +/- 90 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
University of Michigan
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: