Randomized Noninferiority Trial of Telephone Versus In-Person Genetic Counseling for Hereditary Breast and Ovarian Cancer

Abstract

A B S T R A C T PurposeAlthough guidelines recommend in-person counseling before BRCA1/BRCA2 gene testing, genetic counseling is increasingly offered by telephone. As genomic testing becomes more common, evaluating alternative delivery approaches becomes increasingly salient. We tested whether telephone delivery of BRCA1/2 genetic counseling was noninferior to in-person delivery. Patients and MethodsParticipants (women age 21 to 85 years who did not have newly diagnosed or metastatic cancer and lived within a study site catchment area) were randomly assigned to usual care (UC; n ϭ 334) or telephone counseling (TC; n ϭ 335). UC participants received in-person pre-and post-test counseling; TC participants completed all counseling by telephone. Primary outcomes were knowledge, satisfaction, decision conflict, distress, and quality of life; secondary outcomes were equivalence of BRCA1/2 test uptake and costs of delivering TC versus UC. ResultsTC was noninferior to UC on all primary outcomes. At 2 weeks after pretest counseling, knowledge (d ϭ 0.03; lower bound of 97.5% CI, Ϫ0.61), perceived stress (d ϭ Ϫ0.12; upper bound of 97.5% CI, 0.21), and satisfaction (d ϭ Ϫ0.16; lower bound of 97.5% CI, Ϫ0.70) had group differences and confidence intervals that did not cross their 1-point noninferiority limits. Decision conflict (d ϭ 1.1; upper bound of 97.5% CI, 3.3) and cancer distress (d ϭ Ϫ1.6; upper bound of 97.5% CI, 0.27) did not cross their 4-point noninferiority limit. Results were comparable at 3 months. TC was not equivalent to UC on BRCA1/2 test uptake (UC, 90.1%; TC, 84.2%). TC yielded cost savings of $114 per patient. ConclusionGenetic counseling can be effectively and efficiently delivered via telephone to increase access and decrease costs. J Clin

Primary care providers’ cancer genetic testing-related knowledge, attitudes, and communication behaviors: A systematic review and research agenda

“…PCPs could benefit from genetics-related electronic health record tools, and those in community settings could particularly benefit from a team-based approach that includes assistance of a genetic professional trained in risk assessment and communication. Future research to evaluate technology-based approaches that extend the reach of a limited genetics workforce, such as telegenetics, 76,77 telephone counseling, 78,79 and web-based case conferencing, 80 may address this need.…”

Patient feedback and early outcome data with a novel tiered-binned model for multiplex breast cancer susceptibility testing

“…25 Larger, prospective, longitudinal studies are needed to confirm these results and to better understand how outcomes vary for individuals and by test result. While telephone has been increasingly utilized for delivery of BRCA1/2 genetic counseling and testing and seems to have equivalent outcomes for those who proceed with testing, 38,39 many patients expressed concern with the use of alternative delivery models in this setting. Thus, outcomes of telephone and videoconferencing counseling and disclosures in the setting of multiplex testing will need to be studied further.…”

BRCA1/2 Population Screening: Embracing the Benefits

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