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

• ©American Society of Clinical Oncology

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

1. Marc D. Schwartz⇑, 
2. Heiddis B. Valdimarsdottir, 
3. Beth N. Peshkin,
4. Jeanne Mandelblatt, 
5. Rachel Nusbaum, 
6. An-Tsun Huang, 
7. Yaojen Chang,
8. Kristi Graves, 
9. Claudine Isaacs, 
10. Marie Wood, 
11. Wendy McKinnon, 
12. Judy Garber,
13. Shelley McCormick, 
14. Anita Y. Kinney, 
15. George Luta, 
16. Sarah Kelleher,
17. Kara-Grace Leventhal, 
18. Patti Vegella, 
19. Angie Tong and 
20. Lesley King

+Author Affiliations

1. Marc D. Schwartz, Beth N. Peshkin, Jeanne Mandelblatt, Rachel Nusum, An-Tsun Huang, Yaojen Chang, Kristi Graves, Claudine Isaacs, George Luta, Sarah Kelleher, Kara-Grace Leventhal, Patti Vegella, Angie Tong, and Lesley King, Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Heiddis B. Valdimarsdottir, Mount Sinai School of Medicine, New York, NY; Marie Wood and Wendy McKinnon, Familial Cancer Program of the Vermont Cancer Center, University of Vermont College of Medicine, Burlington, VT; Judy Garber and Shelley McCormick, Dana-Farber Cancer Institute-Harvard Medical School, Boston, MA; and Anita Y. Kinney, University of Utah School of Medicine and Huntsman Cancer Institute, Salt Lake City, UT.

1. Corresponding author: Marc D. Schwartz, PhD, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, 3300 Whitehaven St NW, Suite 4100, Washington, DC 20007; e-mail: schwartm@georgetown.edu.

Abstract

Purpose Although guidelines recommend in-person counseling beforeBRCA1/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.

Footnotes

• See accompanying editorial doi: 10.1200/JCO.2013.53.8975