The Genetic Information and Family Testing (GIFT) Study

Launched by UNIVERSITY OF MICHIGAN ROGEL CANCER CENTER · Sep 20, 2022

Keywords

ClinConnect Summary

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, a...

Gender

ALL

Eligibility criteria

• Inclusion criteria for the PICS survey are:
• • 1. diagnosed with any cancer at any stage in 2018-2019 and reported to the Georgia or California SEER registries
• • 2. 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
• • 3. aged 18 or older
• • 4. 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:
• • 1. Receipt of genetic testing for cancer risk
• • 2. A positive test result (pathogenic variant; PV)
• Inclusion criteria for Relative Trial Invitation are assessed via patient report:
• • 1. 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;
• • 2. aged 18 or older;
• • 3. alive at the time of study invitation;
• • 4. relative lives in the United States or Canada (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:
• • 1. 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);
• • 2. confirmation of age 18 or older;
• • 3. 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.
• • 4. confirmation of residence in United States or Canada
• • Exclusion Criteria
• Exclusion criteria for the PICS survey are:
• • 1) Age\<18
• Additional exclusion criteria for Patient Trial Invitation:
• • 1. Patients who do not report receipt of genetic testing
• • 2. Patients who do not report a positive genetic test result (PV)
• Exclusion criteria for Relative Trial Invitation are:
• • 1. Age\<18
• • 2. Relative does not live in the United States or Canada
• Additional exclusion criteria for Relative Trial Enrollment include relative report of:
• • 1. Age\<18;
• • 2. Receipt of genetic testing ordered by a doctor or genetic counselor within the past five years;
• • 3. Relationship to proband (inviting) patient other than first- or second-degree relative
• • 4. Residence in a country other than United States or Canada