The Genetic Information and Family Testing (GIFT) Study

Study Overview
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Brief Summary
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The Genetic Information and Family Testing (GIFT) Study is designed to support the capacity, opportunity, and motivation of cancer patients to engage their relatives about inherited cancer susceptibility and provide support and services to those relatives to initiate GRE (including genetic testing) and prepare them to subsequently engage their clinicians in informed decision-making about cancer prevention and early detection.

Detailed Description
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GIFT features a web-based intervention that offers access to an online family communication program containing key facts about genetics, cancer risk, and the role of genetic testing and helps patients share health information with their first-and second-degree relatives, whom they can invite to join the study to receive education/support and access to low-cost genetic testing. Two design features of the intervention will be randomized and evaluated to determine the best approach for future scalability. Those eligible will be offered enrollment into the Michigan-hosted intervention trial, and those who enroll will be randomized into 1 of 4 study arms. Patients can invite their relatives to enroll and receive genetic testing via Color. Families randomized to the arms with human Navigator support will also have access to a Family Health Navigator at Stanford University. Enrolled patients and relatives will be surveyed six months post-enrollment to collect additional information regarding their interactions with the GIFT platform and their experiences with genetic risk evaluation. Study phase and approximate sample size is summarized below: Initial patient sample selected- 5250 patients Respondents to PICS survey- 3150 patients Pool of patients eligible for GIFT study invitation- 2930 patients Patient GIFT study participants- 880 patients Relatives invited to the GIFT study- 3520 relatives Relative GIFT study participants- 1584 relatives

Official Title
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The Genetic Information and Family Testing (GIFT) Study

Conditions
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Cancer

Intervention / Treatment
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* Genetic: GIFT


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for the PICS survey are: diagnosed with any cancer at any stage in 2018-2019 and reported to the Georgia or California SEER registries Been found to carry a pathogenic variant (PV) in one of 27 cancer susceptibility genes (see Table 4) according to the Georgia California Genetic Testing Linkage Initiative dataset aged 18 or older alive at the time of selection as determined through linkage with Georgia and California vital statistics data. Additional eligibility criteria for Patient Trial Invitation will be evaluated from patient response to the PICS survey and will include patient report of: Receipt of genetic testing for cancer risk A positive test result (pathogenic variant; PV) Inclusion criteria for Relative Trial Invitation are assessed via patient report: first-degree (biological parent, sibling, or biological child) or second-degree (biological half-sibling, aunt, uncle, nephew, niece, grandparent, or grandchild) relative of a patient enrolled in the study; aged 18 or older; alive at the time of study invitation; relative lives in the United States, Canada, or Mexico (countries in which Color genetic testing is available, most people speak either English or Spanish, and test kit shipping costs are not exorbitant) Additional eligibility criteria for Relative Trial Enrollment will be evaluated from relative response to the relative eligibility screening survey (see Appendix C) and will include: confirmation from the relative that they have not received clinical genetic testing ordered by a doctor or genetic counselor within the past five years (proxy for having already been tested for the PV carried by the patient who invited them into the study); confirmation of age 18 or older; confirmation of first-degree (biological parent, sibling, or biological child) or second-degree (biological half-sibling, aunt, uncle, nephew, niece, grandparent, or grandchild) relation to the patient. confirmation of residence in United States, Canada, or Mexico Exclusion Criteria Exclusion criteria for the PICS survey are: 1) Age<18 Additional exclusion criteria for Patient Trial Invitation: Patients who do not report receipt of genetic testing Patients who do not report a positive genetic test result (PV) Exclusion criteria for Relative Trial Invitation are: Age<18 Relative does not live in the United States, Canada, or Mexico Additional exclusion criteria for Relative Trial Enrollment include relative report of: Age<18; Receipt of genetic testing ordered by a doctor or genetic counselor within the past five years; Relationship to proband (inviting) patient other than first- or second-degree relative Residence in a country other than United States, Canada, or Mexico

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The trial is a 2x2 factorial prospective RCT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted. | Genetic: GIFT<br>* GIFT features a web-based intervention that offers access to an online family communication program containing key facts about genetics, cancer risk, and the role of genetic testing and helps patients share health information with their first-and second-degree relatives, whom they can invite to join the study to receive education/support and access to low-cost genetic testing.<br>|
| Other: Arm 2<br>Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted. | Genetic: GIFT<br>* GIFT features a web-based intervention that offers access to an online family communication program containing key facts about genetics, cancer risk, and the role of genetic testing and helps patients share health information with their first-and second-degree relatives, whom they can invite to join the study to receive education/support and access to low-cost genetic testing.<br>|
| Other: Arm 3<br>Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted. | Genetic: GIFT<br>* GIFT features a web-based intervention that offers access to an online family communication program containing key facts about genetics, cancer risk, and the role of genetic testing and helps patients share health information with their first-and second-degree relatives, whom they can invite to join the study to receive education/support and access to low-cost genetic testing.<br>|
| Other: Arm 4<br>Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted. | Genetic: GIFT<br>* GIFT features a web-based intervention that offers access to an online family communication program containing key facts about genetics, cancer risk, and the role of genetic testing and helps patients share health information with their first-and second-degree relatives, whom they can invite to join the study to receive education/support and access to low-cost genetic testing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the independent effects of the two virtual platform design features on relatives' receipt of genetic testing. | The proportion of each enrolled patient's 1st and 2nd degree relatives who receive Color genetic testing through the GIFT platform. For each enrolled patient, this will be calculated as the number of enrolled relatives who obtain a genetic test result from Color (complete the genetic testing process) via the GIFT Study divided by the number of relatives reported on the baseline PICS survey. The endpoint of interest is the presence (as opposed to the absence) of a test result (e.g., positive, uncertain, negative) on the Color Quarterly Report. Assessed six months after the final relative enrolls in the study. | 6 months after the final relative enrolls | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the independent effects of the two virtual platform design features on the proportion of relatives invited by each patient to enroll in the study. | The proportion of each enrolled patient's relatives who are invited to join the study. For each enrolled patient: Number of invited relatives / Number of relatives reported on baseline PICS survey Assessed 91 days after the final patient enrolls in the study. | 91 days after the final patient enrolls | 
| To determine the independent effects of the two virtual platform design features on the cancer patients' assessment of communication with their relatives about hereditary cancer and genetic risk evaluation. | A 20-item scale with responses on a 5-point Likert from not at all true to very true. Items assess patients' capacity, opportunity, and motivation to communicate with family members about their genetic test results. The outcome is continuous and we will measure the change in mean score from baseline to follow-up survey. A greater difference between timepoints will indicate greater improvement in the patient's assessment of their communication with relatives. Assessed at two time points: baseline PICS survey and Patient Six-Month Follow-up Survey. | After the 6 month follow up survey | 
| To determine the independent effects of the two virtual platform design features on relatives' receipt of a formal cancer genetic counseling session in practice. | Single question on a binary yes/no scale. Yes will indicate receipt of formal GRE. Assessed in the Relative Six-Month Follow-Up Survey | After the 6 month follow up survey | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genetic Testing, Family testing