Effectiveness of Telephone Genetic Counseling for Hereditary Breast and Ovarian Cancer: a Randomized Noninferiority Trial
1University of New Mexico, Cancer Center, USA
2Department of Internal Medicine, University of New Mexico, USA
3University of Utah, Huntsman Cancer Institute, USA
4University of Utah School of Medicine, Department of Internal Medicine, USA
5University of Utah, Department of Oncological Sciences, USA
6Georgetown University Medical Center and Cancer Prevention and Control Program, Department of Oncology, USA
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.