The Genetic Information and Family Testing (GIFT) trial.

Abstract

LBA10606 Background: Engaging patients with inherited cancer susceptibility is a potentially powerful strategy to reduce the gap in genetic risk evaluation for their families. The goal of the GIFT Trial is to engage patients to provide support to their relatives to initiate cancer genetic risk education and at-home germline genetic testing. Methods: GIFT is a 2x2 factorial cluster-randomized trial to implement and evaluate a direct-to-family, online education and communication tool including the offer of home genetic testing. We identified 4300 adult patients with any cancer type diagnosed in Georgia and California in 2018-19 who linked to a pathogenic variant (PV) in a clinically tested cancer susceptibility gene through a unique SEER-based data infrastructure, and surveyed those who were alive at time of selection four years after diagnosis (N=2285 completed surveys, response rate 55%). We invited all eligible respondents (recalled PV on germline genetic testing) to enroll in GIFT. Enrolled patients could invite their eligible first- and second-degree relatives to enroll. The index patient subject was randomized after consent, and relatives were then cluster-randomized by family. All participants received some level of intervention, including at least the online tool with information about genetic testing and an offer to relatives of home genetic testing through the tool. We examined the effects of two intervention features: 1) the level of family genetic risk navigation support: a technology-assisted, 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 relatives (free vs $50, provided by Color Health). The primary endpoint is the Family Genetic Testing Fraction (the proportion of each patient's first and second-degree relatives who received testing through the tool). Results: 2,006 of 2285 patient respondents were eligible and invited to GIFT (87.8%) and 412 enrolled (20.5%). Enrolled patients had a total of 5016 first- and second-degree relatives, of whom 945 were invited (18.8%), 298 enrolled (5.9%), and 270 received genetic test results (5.4%). The Table shows differences in the outcome by trial arm adjusted by the number of family members and gender of the invited relative. Conclusions: Patient and relatives’ engagement in GIFT was substantial but lower than anticipated. Free vs. low-cost had a modest effect on test rate, while there was no significant effect of the human navigator. GIFT demonstrates how an online genetic risk education and genetic testing tool can be delivered to families with hereditary cancer syndromes through a population-based approach. Trial Registration: NCT05552664 at Clincaltrials.gov September 20, 2022. Funding: NCI U01CA254822, P30CA046592, and ACS RSG-20-025-01. Clinical trial information: NCT05552664 . Test Cost (0 vs $50) Human Navigator (Yes vs No) Family Test Fraction 4.5% (95% CI 1.9%, 7.4%) 1.4% (95% CI -0.9%, 3.3%)