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| Name | Class |
|---|---|
| University of Michigan | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally facilitated platform | Other | This group will receive access to low-cost genetic testing via an email link and an access code. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Proportion of index patients for whom at least one eligible relative undergoes genetic testing through Color Health in each study arm |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria - Probands
Exclusion Criteria - Probands
1. Unable to read and write English or Spanish.
Inclusion Criteria - Relatives
Exclusion Criteria - Relatives
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonia Rios-Ventura | Contact | 6507258762 | proactprogram@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Allison Kurian, MD | Stanford University | Principal Investigator |
| Jennifer Lee Caswell-Jin, MD | Stanford University | Principal Investigator |
| Steven Katz, MD |
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| ID | Term |
|---|---|
| D020022 | Genetic Predisposition to Disease |
| ID | Term |
|---|---|
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
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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 | 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 | 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] | Proportion of relatives who completed the genetic risk education modules as measured by platform paradata [PROACT platform-AI Arm Only] | 180 days |
| 180 days +/- 90 days |
| Relatives' confidence in their understanding of hereditary cancer risk | To compare enrolled relatives' confidence in their understanding of hereditary cancer risk, using interviews. | 180 days +/- 90 days |
| 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. | 6 months |
| 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. | 180 days +/- 90 days |
| University of Michigan |
| Principal Investigator |
| Lawrence An, MD | University of Michigan | Principal Investigator |