The Genetic Information and Family Testing (GIFT) study: trial design and protocol

BackgroundThere is pressing need to develop and evaluate clinically sound approaches to supporting the engagement between patients who have inherited cancer susceptibility and their relatives who may share it. Identifying and engaging patients with an inherited cancer susceptibility in the community is a potentially powerful strategy to reduce the gap in genetic risk evaluation for their families. The goal of the Genetic Information and Family Testing (GIFT) Study is to engage patients about inherited cancer susceptibility and provide support and services to their relatives to initiate genetic risk evaluation (including choice of home genetic testing).Methods/designWe are conducting a population-based, 2 x 2 factorial cluster-randomized clinical trial to implement and evaluate a direct-to-family, virtual, personalized, family-centered communication and decision-making tool: the Family Genetic Health Program. We use a unique SEER-based data infrastructure that we pioneered to identify patients diagnosed with cancer in the states of Georgia and California who carry a pathogenic variant (PV) in clinically tested cancer susceptibility gene. Eligible patients are offered enrollment into the trial and can invite their eligible first- and second-degree relatives to enroll. The index subject is randomized, and relatives are then cluster randomized by family. Participants in all arms receive some level of intervention, including at least the web-based platform with information about genetic testing and, for the relatives, an option to receive genetic testing through the study platform. We study the effects of two intervention design features: (1) the level of personalized family genetic risk navigation support: a technology-assisted, personally tailored patient and family member education and communication tool vs. the tool plus direct assistance from a lay human navigator); and (2) the cost of the genetic test offered to the relatives ($50 vs. free).DiscussionGIFT is a blueprint for how a virtual cascade genetic risk program can be delivered in the community, through a population-based approach to patients and relatives in families with hereditary cancer syndromes. The vision, experiences, and findings from GIFT will inform next-generation implementation science and the results will pertain to stakeholders interested in a population-based approach to cascade genetic risk evaluation.Trial registrationNCT05552664 registered at Clincaltrials.gov September 20, 2022.