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

• Published in: Journal of clinical oncology Vol. 32; no. 7; pp. 618 - 626
• Main Authors: Schwartz, Marc D., Valdimarsdottir, Heiddis B., Peshkin, Beth N., Mandelblatt, Jeanne, Nusbaum, Rachel, Huang, An-Tsun, Chang, Yaojen, Graves, Kristi, Isaacs, Claudine, Wood, Marie, McKinnon, Wendy, Garber, Judy, McCormick, Shelley, Kinney, Anita Y., Luta, George, Kelleher, Sarah, Leventhal, Kara-Grace, Vegella, Patti, Tong, Angie, King, Lesley
• Format: Journal Article
• Language: English
• Published: Alexandria, VA American Society of Clinical Oncology 01.03.2014
• Subjects: Adult; Aged; Aged, 80 and over; Biological and medical sciences; Breast Neoplasms - genetics; Breast Neoplasms - prevention & control; Breast Neoplasms - psychology; Breast Neoplasms - therapy; Conflict (Psychology); Cost-Benefit Analysis; Decision Making; Female; General aspects. Genetic counseling; Genes, BRCA1; Genes, BRCA2; Genetic Counseling - economics; Genetic Counseling - methods; Genetic Testing; Health Knowledge, Attitudes, Practice; Humans; Medical genetics; Medical sciences; Middle Aged; Multiple tumors. Solid tumors. Tumors in childhood (general aspects); Mutation; ORIGINAL REPORTS; Ovarian Neoplasms - genetics; Ovarian Neoplasms - prevention & control; Ovarian Neoplasms - psychology; Ovarian Neoplasms - therapy; Patient Satisfaction; Quality of Life; Stress, Psychological - etiology; Telephone; Tumors; Breast disease; Telephone; Ovary cancer; Breast cancer; Malignant tumor; Female genital diseases; Genetic disease; Mammary gland diseases; Ovarian diseases; Randomization; Cancerology; Genetic counseling; Clinical trial; Comparative study; Cancer
• ISSN: 0732-183X; 1527-7755; 1527-7755
• DOI: 10.1200/JCO.2013.51.3226

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. 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. 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. Genetic counseling can be effectively and efficiently delivered via telephone to increase access and decrease costs.