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

PURPOSE: Although 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 METHODS: Participants (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 = 334) or telephone counseling (TC; n = 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. RESULTS: TC was noninferior to UC on all primary outcomes. At 2 weeks after pretest counseling, knowledge (d = 0. 03; lower bound of 97. 5% CI, -0. 61), perceived stress (d = -0. 12; upper bound of 97. 5% CI, 0. 21), and satisfaction (d = -0. 16; lower bound of 97. 5% CI, -0. 70) had group differences and confidence intervals that did not cross their 1-point noninferiority limits. Decision conflict (d = 1. 1; upper bound of 97. 5% CI, 3. 3) and cancer distress (d = -1. 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. CONCLUSION: Genetic counseling can be effectively and efficiently delivered via telephone to increase access and decrease costs.