Effectiveness of Telephone Genetic Counseling for Hereditary Breast and Ovarian Cancer: a Randomized Noninferiority Trial

Abstract

Background: Because of increasing demand and access issues, there is an urgent need to evaluate alternative genetic service delivery models. Methods: In a randomized clinical trial we tested the equivalency and noninferiority of telephone counseling to remote in-person counseling for hereditary breast and ovarian cancer. Women (n=901), 25-74 years of age, with a personal or family history of breast and/or ovarian cancer completed BRCA1/2 counseling and follow-up assessments 1 week after pre-test and post-test counseling and at 6 months. Findings: Uptake of BRCA1/2 testing was lower following telephone (21.8%) than in-person counseling (31.8%; cluster bootstrap estimate of 95% confidence interval (CI)=3.9%-16.3%; intent-to-treat: 9.2%, CI=-0.1%-24.6%). Telephone counseling was noninferior to in-person counseling in terms of decisional conflict (linear model estimate of between group difference [D] = 0.42; noninferiority one-sided 97.5% CI=1.86), decision regret (D = 2.03; one-sided 97.5% CI=4.66) and patient-centered communication measures. Discussion: Telephone counseling can effectively increase the clinical reach of and access to genetic counseling services.