Family Members, Genetic Predisposition
Conditions
Keywords
Cascade genetic testing
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.
Detailed description
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.
Interventions
OTHERMinimally facilitated platform
This group will receive access to low-cost genetic testing via an email link and an access code.
OTHERAI-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
Sponsors
Stanford University
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of all eligible first- and second-degree relatives who undergo genetic testing through Color Health in each study arm | 6 months | Proportion of all eligible first- and second-degree relatives who undergo genetic testing through Color Health in each study arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of eligible first-degree relatives who undergo genetic testing through Color Health in each study arm | 6 months | Proportion of eligible first-degree relatives who undergo 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 | 6 months | Proportion of index patients for whom at least one eligible relative undergoes genetic testing through Color Health in each study arm |
| Proportion of eligible relatives invited by the patient in each study arm | 180 days | Proportion of eligible relatives invited by the patient in each study arm |
| Proportion of eligible relatives who join the PROACT program in each study arm | 28 days | Proportion of eligible relatives who join the PROACT program in each study arm |
| Proportion of relatives who completed the genetic risk education modules as measured by platform paradata [PROACT platform-AI Arm Only] | 180 days | Proportion of relatives who completed the genetic risk education modules as measured by platform paradata \[PROACT platform-AI Arm Only\] |
Contacts
CONTACTSonia Rios-Ventura
PRINCIPAL_INVESTIGATORAllison Kurian, MD
Stanford University
PRINCIPAL_INVESTIGATORJennifer Lee Caswell-Jin, MD
Stanford University
PRINCIPAL_INVESTIGATORSteven Katz, MD
University of Michigan
PRINCIPAL_INVESTIGATORLawrence An, MD
University of Michigan
Outcome results
None listed