Clinical trial NCT05552664: The Genetic Information and Family Testing (GIFT) Study
Official title: The Genetic Information and Family Testing (GIFT) Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cancer
Keywords: Genetic Testing
Family testing
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-09-23
Enrollment: 2464
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The trial is a 2x2 factorial prospective RCT
Primary purpose: PREVENTION

Brief summary: 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: 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

Study phase and approximate sample size summarizes have been updated below 22NOV2024:

* Initial patient sample selected- 4300 patients
* Respondents to PICS survey- 2358 patients
* Pool of patients eligible for GIFT study invitation- 2030 patients
* Patient GIFT study participants- 412 patients
* Relatives invited to the GIFT study- 1236 relatives
* Relative GIFT study participants- 371 relatives

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

Primary outcomes:
measure: To determine the independent effects of the two virtual platform design features on relatives' receipt of genetic testing.
timeFrame: 6 months after the final relative enrolls
Secondary outcomes:
measure: 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.
timeFrame: 91 days after the final patient enrolls
measure: 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.
timeFrame: After the 6 month follow up survey
measure: To determine the independent effects of the two virtual platform design features on relatives' receipt of a formal cancer genetic counseling session in practice.
timeFrame: After the 6 month follow up survey
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Steven Katz, MD
role: PRINCIPAL_INVESTIGATOR
References: