TY - JOUR
T1 - 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
T2 - The Genetic Education, Risk Assessment, and Testing (GENERATE) Study
AU - Rodriguez, Nicolette J.
AU - Furniss, C. Sloane
AU - Yurgelun, Matthew B.
AU - Ukaegbu, Chinedu
AU - Constantinou, Pamela E.
AU - Fortes, Ileana
AU - Caruso, Alyson
AU - Schwartz, Alison N.
AU - Stopfer, Jill E.
AU - Underhill-Blazey, Meghan
AU - Kenner, Barbara
AU - Nelson, Scott H.
AU - Okumura, Sydney
AU - Zhou, Alicia Y.
AU - Coffin, Tara B.
AU - Uno, Hajime
AU - Horiguchi, Miki
AU - Ocean, Allyson J.
AU - McAllister, Florencia
AU - Lowy, Andrew M.
AU - Klein, Alison P.
AU - Madlensky, Lisa
AU - Petersen, Gloria M.
AU - Garber, Judy E.
AU - Lippman, Scott M.
AU - Goggins, Michael G.
AU - Maitra, Anirban
AU - Syngal, Sapna
N1 - Publisher Copyright:
© 2024 AGA Institute
PY - 2024/5
Y1 - 2024/5
N2 - Background & Aims: Genetic testing uptake for cancer susceptibility in family members of patients with cancer is suboptimal. Among relatives of patients with pancreatic ductal adenocarcinoma (PDAC), The GENetic Education, Risk Assessment, and TEsting (GENERATE) study evaluated 2 online genetic education/testing delivery models and their impact on patient-reported psychological outcomes. Methods: Eligible participants had ≥1 first-degree relative with PDAC, or ≥1 first-/second-degree relative with PDAC with a known pathogenic germline variant in 1 of 13 PDAC predisposition genes. Participants were randomized by family, between May 8, 2019, and June 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 postintervention. Results: A total of 424 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 = .014). Arm 1 participants were significantly less likely to complete genetic testing compared with Arm 2 participants (adjusted ratio [Arm1/Arm2] 0.90, 95% confidence interval 0.78–0.98). Among participants who completed patient-reported psychological outcomes questionnaires (Arm 1 [n = 194]; Arm 2 [n = 206]), the intervention did not affect mean anxiety, depression, or cancer worry scores. Conclusions: Remote genetic education and testing can be a successful and complementary option for delivering genetics care. (Clinicaltrials.gov,
AB - Background & Aims: Genetic testing uptake for cancer susceptibility in family members of patients with cancer is suboptimal. Among relatives of patients with pancreatic ductal adenocarcinoma (PDAC), The GENetic Education, Risk Assessment, and TEsting (GENERATE) study evaluated 2 online genetic education/testing delivery models and their impact on patient-reported psychological outcomes. Methods: Eligible participants had ≥1 first-degree relative with PDAC, or ≥1 first-/second-degree relative with PDAC with a known pathogenic germline variant in 1 of 13 PDAC predisposition genes. Participants were randomized by family, between May 8, 2019, and June 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 postintervention. Results: A total of 424 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 = .014). Arm 1 participants were significantly less likely to complete genetic testing compared with Arm 2 participants (adjusted ratio [Arm1/Arm2] 0.90, 95% confidence interval 0.78–0.98). Among participants who completed patient-reported psychological outcomes questionnaires (Arm 1 [n = 194]; Arm 2 [n = 206]), the intervention did not affect mean anxiety, depression, or cancer worry scores. Conclusions: Remote genetic education and testing can be a successful and complementary option for delivering genetics care. (Clinicaltrials.gov,
KW - Cascade Genetic Testing
KW - Healthcare Delivery
UR - http://www.scopus.com/inward/record.url?scp=85188638713&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85188638713&partnerID=8YFLogxK
U2 - 10.1053/j.gastro.2024.01.042
DO - 10.1053/j.gastro.2024.01.042
M3 - Article
C2 - 38320723
AN - SCOPUS:85188638713
SN - 0016-5085
VL - 166
SP - 872-885.e2
JO - Gastroenterology
JF - Gastroenterology
IS - 5
ER -