. 2017 Sep;1(1):pkx002.

doi: 10.1093/jncics/pkx002. Epub 2017 Sep 22.

Randomized Noninferiority Trial of Telephone vs In-Person Genetic Counseling for Hereditary Breast and Ovarian Cancer: A 12-Month Follow-Up

Mary K Interrante¹, Hannah Segal¹, Beth N Peshkin¹, Heiddis B Valdimarsdottir¹, Rachel Nusbaum¹, Morgan Similuk¹, Tiffani DeMarco¹, Gillian Hooker¹, Kristi Graves¹, Claudine Isaacs¹, Marie Wood¹, Wendy McKinnon¹, Judy Garber¹, Shelley McCormick¹, Jessica Heinzmann¹, Anita Y Kinney¹, Marc D Schwartz¹

Affiliations

Affiliation

¹ Georgetown Lombardi Comprehensive Cancer Center (MKI, HS, BNP, RN, MS, TD, GH, KG, CI, MDS) and Jess and Mildred Fisher Center for Hereditary Cancer and Clinical Genomics Research (MKI, HS, BNP, KG, CI, MDS), Georgetown University, Washington, DC; Department of Oncological Sciences, Icahn School of Medicine at Mount Sinai, New York, NY (HBV, JH); Department of Psychology, Reykjavik University, Reykjavik, Iceland (HBV); School of Medicine, University of Maryland, Baltimore, MD (RN); National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (MS); Cancer Genetic Counseling Program, Inova Translational Medicine Institute, Inova Health System, Falls Church, VA (TD); NextGxDx, Inc, Franklin, TN (GH); Familial Cancer Program of the Vermont Cancer Center, University of Vermont College of Medicine, Burlington, VT (MW, WM); Center for Cancer Genetics and Prevention, Dana-Farber Cancer Institute-Harvard Medical School, Boston, MA (JG, SM); Center for Cancer Risk Assessment, Massachusetts General Hospital Cancer Center, Boston, MA (SM); Carol G. Simon Cancer Center, Atlantic Health Services, Summit, NJ (JH); University of Utah School of Medicine and Huntsman Cancer Institute, Salt Lake City, UT (AYK); Cancer Control and Population Sciences, University of New Mexico Cancer Center, Albuquerque, NM (AYK).

PMID: 31304457
PMCID: PMC6611491
DOI: 10.1093/jncics/pkx002

Randomized Noninferiority Trial of Telephone vs In-Person Genetic Counseling for Hereditary Breast and Ovarian Cancer: A 12-Month Follow-Up

Mary K Interrante et al. JNCI Cancer Spectr. 2017 Sep.

. 2017 Sep;1(1):pkx002.

doi: 10.1093/jncics/pkx002. Epub 2017 Sep 22.

Authors

Affiliation

¹ Georgetown Lombardi Comprehensive Cancer Center (MKI, HS, BNP, RN, MS, TD, GH, KG, CI, MDS) and Jess and Mildred Fisher Center for Hereditary Cancer and Clinical Genomics Research (MKI, HS, BNP, KG, CI, MDS), Georgetown University, Washington, DC; Department of Oncological Sciences, Icahn School of Medicine at Mount Sinai, New York, NY (HBV, JH); Department of Psychology, Reykjavik University, Reykjavik, Iceland (HBV); School of Medicine, University of Maryland, Baltimore, MD (RN); National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (MS); Cancer Genetic Counseling Program, Inova Translational Medicine Institute, Inova Health System, Falls Church, VA (TD); NextGxDx, Inc, Franklin, TN (GH); Familial Cancer Program of the Vermont Cancer Center, University of Vermont College of Medicine, Burlington, VT (MW, WM); Center for Cancer Genetics and Prevention, Dana-Farber Cancer Institute-Harvard Medical School, Boston, MA (JG, SM); Center for Cancer Risk Assessment, Massachusetts General Hospital Cancer Center, Boston, MA (SM); Carol G. Simon Cancer Center, Atlantic Health Services, Summit, NJ (JH); University of Utah School of Medicine and Huntsman Cancer Institute, Salt Lake City, UT (AYK); Cancer Control and Population Sciences, University of New Mexico Cancer Center, Albuquerque, NM (AYK).

PMID: 31304457
PMCID: PMC6611491
DOI: 10.1093/jncics/pkx002

Abstract

Background: Telephone delivery of genetic counseling is an alternative to in-person genetic counseling because it may extend the reach of genetic counseling. Previous reports have established the noninferiority of telephone counseling on short-term psychosocial and decision-making outcomes. Here we examine the long-term impact of telephone counseling (TC) vs in-person counseling (usual care [UC]).

Methods: We recruited high-risk women for a noninferiority trial comparing TC with UC. Of 1057 potentially eligible women, 669 were randomly assigned to TC (n = 335) or UC (n = 334), and 512 completed the 12-month follow-up. Primary outcomes were patient-reported satisfaction with genetic testing decision, distress, and quality of life. Secondary outcomes were uptake of cancer risk management strategies.

Results: TC was noninferior to UC on all primary outcomes. Satisfaction with decision (d = 0.13, lower bound of 97.5% confidence interval [CI] = -0.34) did not cross its one-point noninferiority limit, cancer-specific distress (d = -2.10, upper bound of 97.5% CI = -0.07) did not cross its four-point noninferiority limit, and genetic testing distress (d = -0.27, upper bound of 97.5% CI = 1.46), physical function (d = 0.44, lower bound of 97.5% CI = -0.91) and mental function (d = -0.04, lower bound of 97.5% CI = -1.44) did not cross their 2.5-point noninferiority limit. Bivariate analyses showed no differences in risk-reducing mastectomy or oophorectomy across groups; however, when combined, TC had significantly more risk-reducing surgeries than UC (17.8% vs 10.5%; χ² = 4.43, P = .04).

Conclusions: Findings support telephone delivery of genetic counseling to extend the accessibility of this service without long-term adverse outcomes.

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Figures

**Figure 1.**
Study flow chart. TC = telephone genetic counseling; UC = usual care (in-person genetic counseling).

**Figure 2.**
Adjusted noninferiority analysis of telephone genetic counseling vs usual care (in-person genetic counseling) at 12 months postcounseling. Analyses were adjusted for baseline score on the outcome measure and genetic test result. TC = telephone genetic counseling; UC = usual care (in-person genetic counseling).

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Randomized Noninferiority Trial of Telephone vs In-Person Genetic Counseling for Hereditary Breast and Ovarian Cancer: A 12-Month Follow-Up

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Randomized Noninferiority Trial of Telephone vs In-Person Genetic Counseling for Hereditary Breast and Ovarian Cancer: A 12-Month Follow-Up

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