학술논문
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.
Document Type
Academic Journal
Author
Rodriguez NJ; Dana-Farber Cancer Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Brigham and Women's Hospital, Boston, Massachusetts.; Furniss CS; Dana-Farber Cancer Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.; Yurgelun MB; Dana-Farber Cancer Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Brigham and Women's Hospital, Boston, Massachusetts.; Ukaegbu C; Dana-Farber Cancer Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.; Constantinou PE; Sheikh Ahmed Center for Pancreatic Cancer Research, University of Texas, MD Anderson Cancer Center, Houston, Texas.; Fortes I; Dana-Farber Cancer Institute, Boston, Massachusetts.; Caruso A; Dana-Farber Cancer Institute, Boston, Massachusetts.; Schwartz AN; Dana-Farber Cancer Institute, Boston, Massachusetts.; Stopfer JE; Dana-Farber Cancer Institute, Boston, Massachusetts.; Underhill-Blazey M; University of Rochester, School of Nursing, Rochester, New York.; Kenner B; Kenner Family Research Fund, New York, New York.; Nelson SH; Pancreatic Cancer Action Network Volunteer, Patient Advocate, and Pancreatic Cancer Survivor.; Okumura S; Color Genomics, Burlingame, California.; Zhou AY; Color Genomics, Burlingame, California.; Coffin TB; WIRB-Copernicus Group Institutional Review Board, Puyallup, Washington.; Uno H; Dana-Farber Cancer Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.; Horiguchi M; Dana-Farber Cancer Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.; Ocean AJ; Weill Cornell Medical Center, New York, New York.; McAllister F; Sheikh Ahmed Center for Pancreatic Cancer Research, University of Texas, MD Anderson Cancer Center, Houston, Texas.; Lowy AM; Moores Cancer Center, UC San Diego, San Diego, California.; Klein AP; Johns Hopkins University, Sol Goldman Pancreatic Cancer Research Center, Baltimore, Maryland.; Madlensky L; Moores Cancer Center, UC San Diego, San Diego, California.; Petersen GM; Mayo Clinic Cancer Center, Rochester, Minnesota.; Garber JE; Dana-Farber Cancer Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Brigham and Women's Hospital, Boston, Massachusetts.; Lippman SM; Moores Cancer Center, UC San Diego, San Diego, California.; Goggins MG; Johns Hopkins University, Sol Goldman Pancreatic Cancer Research Center, Baltimore, Maryland.; Maitra A; Sheikh Ahmed Center for Pancreatic Cancer Research, University of Texas, MD Anderson Cancer Center, Houston, Texas.; Syngal S; Dana-Farber Cancer Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: Sapna_Syngal@dfci.harvard.edu.
Source
Publisher: W.B. Saunders Country of Publication: United States NLM ID: 0374630 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1528-0012 (Electronic) Linking ISSN: 00165085 NLM ISO Abbreviation: Gastroenterology Subsets: MEDLINE
Subject
Language
English
Abstract
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, number NCT03762590).
(Copyright © 2024 AGA Institute. Published by Elsevier Inc. All rights reserved.)
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, number NCT03762590).
(Copyright © 2024 AGA Institute. Published by Elsevier Inc. All rights reserved.)