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JCO oncology practice · 2023

Pretest Video Education Versus Genetic Counseling for Patients With Prostate Cancer: ProGen, A Multisite Randomized Controlled Trial.

СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Rana Huma Q, Stopfer Jill E, Weitz Michelle, Kipnis Lindsay, Koeller Diane R, Culver Samantha, Mercado Joanna, Gelman Rebecca Sue, Underhill-Blazey Meghan, McGregor Bradley A, Sweeney Christopher J, Petrucelli Nancie, Kokenakes Courtney, Pirzadeh-Miller Sara, Reys Brian, Frazier Arthur, Knechtl Andrew, Fateh Salman, Vatnick Donna Rachel, Silver Rebecca, Kilbridge Kerry E, Pomerantz Mark M, Wei Xiao X, Choudhury Atish D, Sonpavde Guru P, Kozyreva Olga, Lathan Christopher, Horton Carrie, Dolinsky Jill S, Heath Elisabeth I, Ross Theodora Suzanne, Courtney Kevin Dale, Garber Judy E, Taplin Mary-Ellen

Аннотация

PURPOSE: Germline genetic testing (GT) is recommended for men with prostate cancer (PC), but testing through traditional models is limited. The ProGen study examined a novel model aimed at providing access to GT while promoting education and informed consent.

METHODS: Men with potentially lethal PC (metastatic, localized with a Gleason score of ≥8, persistent prostate-specific antigen after local therapy), diagnosis age ≤55 years, previous malignancy, and family history suggestive of a pathogenic variant (PV) and/or at oncologist's discretion were randomly assigned 3:1 to video education (VE) or in-person genetic counseling (GC). Participants had 67 genes analyzed (Ambry), with results disclosed via telephone by a genetic counselor. Outcomes included GT consent, GT completion, PV prevalence, and survey measures of satisfaction, psychological impact, genetics knowledge, and family communication. Two-sided Fisher's exact tests were used for between-arm comparisons.

RESULTS: Over a 2-year period, 662 participants at three sites were randomly assigned and pretest VE (n = 498) or GC (n = 164) was completed by 604 participants (VE, 93.1%; GC, 88.8%), of whom 596 participants (VE, 98.9%; GC, 97.9%) consented to GT and 591 participants completed GT (VE, 99.3%; GC, 98.6%). These differences were not statistically significant although subtle differences in satisfaction and psychological impact were. Notably, 84 PVs were identified in 78 participants (13.2%), with BRCA1/2 PV comprising 32% of participants with a positive result (BRCA2 n = 21, BRCA1 n = 4).

CONCLUSION: Both VE and traditional GC yielded high GT uptake without significant differences in outcome measures of completion, GT uptake, genetics knowledge, and family communication. The increased demand for GT with limited genetics resources supports consideration of pretest VE for patients with PC.

Предметные рубрики MeSH

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты