NCT05552664

The Genetic Information and Family Testing (GIFT) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,002 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 and IRB approved 29SEP2025: * 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

Conditions

• Cancer

Interventions

Type	Name	Description
GENETIC	GIFT	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.

Timeline

• Start date: 2022-10-24
• Primary completion: 2025-07-10
• Completion: 2025-08-10
• First posted: 2022-09-23
• Last updated: 2026-01-26

Locations

4 sites across 1 country: United States