TY - JOUR
T1 - Pretest Video Education Versus Genetic Counseling for Patients with Prostate Cancer
T2 - ProGen, A Multisite Randomized Controlled Trial
AU - Rana, Huma Q.
AU - Stopfer, Jill E.
AU - Weitz, Michelle
AU - Kipnis, Lindsay
AU - Koeller, Diane R.
AU - Culver, Samantha
AU - Mercado, Joanna
AU - Gelman, Rebecca Sue
AU - Underhill-Blazey, Meghan
AU - McGregor, Bradley A.
AU - Sweeney, Christopher J.
AU - Petrucelli, Nancie
AU - Kokenakes, Courtney
AU - Pirzadeh-Miller, Sara
AU - Reys, Brian
AU - Frazier, Arthur
AU - Knechtl, Andrew
AU - Fateh, Salman
AU - Vatnick, Donna Rachel
AU - Silver, Rebecca
AU - Kilbridge, Kerry E.
AU - Pomerantz, Mark M.
AU - Wei, Xiao X.
AU - Choudhury, Atish D.
AU - Sonpavde, Guru P.
AU - Kozyreva, Olga
AU - Lathan, Christopher
AU - Horton, Carrie
AU - Dolinsky, Jill S.
AU - Heath, Elisabeth I.
AU - Ross, Theodora Suzanne
AU - Courtney, Kevin Dale
AU - Garber, Judy E.
AU - Taplin, Mary Ellen
N1 - Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2023/11/1
Y1 - 2023/11/1
N2 - 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.METHODSMen 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.RESULTSOver 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).CONCLUSIONBoth 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.
AB - 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.METHODSMen 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.RESULTSOver 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).CONCLUSIONBoth 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.
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U2 - 10.1200/OP.23.00007
DO - 10.1200/OP.23.00007
M3 - Article
C2 - 37733980
AN - SCOPUS:85176508578
SN - 2688-1527
VL - 19
SP - 1069
EP - 1079
JO - JCO Oncology Practice
JF - JCO Oncology Practice
IS - 11
ER -