A Randomized Trial of Two Remote Health Care Delivery Models on the Uptake of Genetic Testing and Impact on Patient-Reported Psychological Outcomes in Families With Pancreatic Cancer: The Genetic Education, Risk Assessment, and Testing (GENERATE) Study

Abstract

Background and AimsGenetic testing uptake for cancer susceptibility in family members of cancer patients is suboptimal. Among relatives of pancreatic ductal adenocarcinoma (PDAC) patients, The GENetic Education, Risk Assessment, and TEsting (GENERATE) study evaluated two online genetic education/testing delivery models and their impact on patient-reported psychological outcomes (PRPOs). MethodsEligible participants had ≥1 first-degree relative with PDAC, or ≥1 first-/second-degree relative with PDAC with a known pathogenic germline variant in one of thirteen PDAC predisposition genes. Participants were randomized by family, between 5/8/2019-6/1/2021. Arm 1 participants underwent a remote interactive telemedicine session and online genetic education. Arm 2 participants were offered online genetic education only. All participants were offered germline testing. The primary outcome was genetic testing uptake, compared by permutation tests and mixed-effects logistic regression models. We hypothesized that Arm 1 participants would have a higher genetic testing uptake than Arm 2. Validated surveys were administered to assess patient-reported anxiety, depression, and cancer worry at baseline and 3-months post-intervention. Results424 families were randomized, including 601 participants (n=296 Arm 1; n=305 Arm 2), 90% of whom completed genetic testing (Arm 1 (87%); Arm 2 (93%), p=0.014). Arm 1 participants were significantly less likely to complete genetic testing compared to Arm 2 (adjusted ratio (Arm1/Arm2) 0.90, 95% confidence interval 0.78-0.98). Among participants who completed PRPO questionnaires (Arm 1 (n=194); Arm 2 (n=206)), the intervention did not impact mean anxiety, depression or cancer worry scores. ConclusionsRemote genetic education and testing can be a successful and complementary option for delivering genetics care.