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J Clin Oncol. 2014 Mar 1;32(7):618-26. doi: 10.1200/JCO.2013.51.3226. Epub 2014 Jan 21.

Randomized noninferiority trial of telephone versus in-person genetic counseling for hereditary breast and ovarian cancer.

Author information

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.

Abstract

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00287898.

PMID:
24449235
PMCID:
PMC3927731
DOI:
10.1200/JCO.2013.51.3226
[Indexed for MEDLINE]
Free PMC Article

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