The Genetic Information and Family Testing (GIFT) Study
- Conditions
- Cancer
- Interventions
- Genetic: GIFT
- Registration Number
- NCT05552664
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- 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
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 2464
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Arm 3 GIFT 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. Arm 2 GIFT 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. Arm 4 GIFT 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. Arm 1 GIFT 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.
- Primary Outcome Measures
Name Time Method To determine the independent effects of the two virtual platform design features on relatives' receipt of genetic testing. 6 months after the final relative enrolls 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.
- Secondary Outcome Measures
Name Time Method To determine the independent effects of the two virtual platform design features on relatives' receipt of a formal cancer genetic counseling session in practice. After the 6 month follow up survey Single question on a binary yes/no scale. Yes will indicate receipt of formal GRE.
Assessed in the Relative Six-Month Follow-Up SurveyTo 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. 91 days after the final patient enrolls 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.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. After the 6 month follow up survey 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.
Trial Locations
- Locations (4)
University of Southern California
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Stanford, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Michigan Rogel Cancer Center
🇺🇸Ann Arbor, Michigan, United States