The Genetic Information and Family Testing (GIFT) Study

Trial Title: The Genetic Information and Family Testing (GIFT) Study

NCT ID: NCT05552664

Condition: Cancer

Conditions: Keywords:
Genetic Testing
Family testing

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: Randomized

Intervention model: Factorial Assignment

Intervention model description: The trial is a 2x2 factorial prospective RCT

Primary purpose: Prevention

Masking: Single (Participant)

Masking description: Randomization will be concealed from study participants; enrolled patients and relatives will not be aware that their family has been randomized into one of four trial arms and provided a different intervention experience than the other study participants. Concealment is necessary for this study so that the trial can observe differences across the trial arms without a) negatively impacting study enrollment and biasing the study, and b) causing unnecessary negative emotional reactions in study participants.

Intervention:

Intervention type: Genetic
Intervention name: GIFT
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.
Arm group label: Arm 1
Arm group label: Arm 2
Arm group label: Arm 3
Arm group label: Arm 4

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

Criteria for 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, 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: 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, Canada, or Mexico 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, Canada, or Mexico 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, Canada, or Mexico

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Southern California

Address:
City: Los Angeles
Zip: 90007
Country: United States

Facility:
Name: Stanford University

Address:
City: Stanford
Zip: 94305
Country: United States

Facility:
Name: Emory University

Address:
City: Atlanta
Zip: 30322
Country: United States

Facility:
Name: University of Michigan Rogel Cancer Center

Address:
City: Ann Arbor
Zip: 48108
Country: United States

Start date: October 24, 2022

Completion date: October 31, 2026

Lead sponsor:
Agency: University of Michigan Rogel Cancer Center
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: University of Michigan Rogel Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05552664