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

JNCI Cancer Spectrum

Garber, Judy¹  Similuk, Morgan²  Wood, Marie³  Graves, Kristi⁴  Isaacs, Claudine⁵  Heinzmann, Jessica⁶  Segal, Hannah⁶  Peshkin, Beth N.⁷  Kinney, Anita Y.⁷  Hooker, Gillian⁸  Nusbaum, Rachel⁹  DeMarco, Tiffani^1,10  Schwartz, Marc D.^1,11  Valdimarsdottir, Heiddis B.^1,11  McKinnon, Wendy^1,12  Interrante, Mary K.^1,13  McCormick, Shelley^1,13 

[1] Cancer Control and Population Sciences, University of New Mexico Cancer Center, Albuquerque, NM (AYK).;Cancer Genetic Counseling Program, Inova Translational Medicine Institute, Inova Health System, Falls Church, VA (TD);Carol G. Simon Cancer Center, Atlantic Health Services, Summit, NJ (JH);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);Department of Oncological Sciences, Icahn School of Medicine at Mount Sinai, New York, NY (HBV, JH);Department of Psychology, Reykjavik University, Reykjavik, Iceland (HBV);Familial Cancer Program of the Vermont Cancer Center, University of Vermont College of Medicine, Burlington, VT (MW, WM);National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (MS);NextGxDx, Inc, Franklin, TN (GH);School of Medicine, University of Maryland, Baltimore, MD (RN);University of Utah School of Medicine and Huntsman Cancer Institute, Salt Lake City, UT (AYK);Affiliations of authors: 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

关键词: counseling;    follow-up;    telephone;    non-inferiority trials;    cancer;    quality of life;    surgical procedures, operative;   

DOI  :  10.1093/jncics/pkx002

学科分类：肿瘤学

来源: Oxford University Press

【 摘 要 】

BackgroundTelephone 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]).MethodsWe 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.ResultsTC 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).ConclusionsFindings support telephone delivery of genetic counseling to extend the accessibility of this service without long-term adverse outcomes.

【 授权许可】

CC BY-NC-ND