遗传性乳腺癌和卵巢癌电话咨询与面对面遗传咨询的随机非劣效性试验：12个月随访
Randomized Noninferiority Trial of Telephone vs In-Person Genetic Counseling for Hereditary Breast and Ovarian Cancer: A 12-Month Follow-Up.
作者信息
Interrante Mary K, Segal Hannah, Peshkin Beth N, Valdimarsdottir Heiddis B, Nusbaum Rachel, Similuk Morgan, DeMarco Tiffani, Hooker Gillian, Graves Kristi, Isaacs Claudine, Wood Marie, McKinnon Wendy, Garber Judy, McCormick Shelley, Heinzmann Jessica, Kinney Anita Y, Schwartz Marc D
机构信息
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).
出版信息
JNCI Cancer Spectr. 2017 Sep;1(1):pkx002. doi: 10.1093/jncics/pkx002. Epub 2017 Sep 22.
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 (0.13, lower bound of 97.5% confidence interval [CI] = -0.34) did not cross its one-point noninferiority limit, cancer-specific distress (-2.10, upper bound of 97.5% CI = -0.07) did not cross its four-point noninferiority limit, and genetic testing distress (-0.27, upper bound of 97.5% CI = 1.46), physical function (0.44, lower bound of 97.5% CI = -0.91) and mental function (-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%; = 4.43, .04).
CONCLUSIONS
Findings support telephone delivery of genetic counseling to extend the accessibility of this service without long-term adverse outcomes.
背景
电话遗传咨询是面对面遗传咨询的一种替代方式，因为它可能会扩大遗传咨询的覆盖范围。先前的报告已证实电话咨询在短期心理社会和决策结果方面并不逊色。在此，我们研究电话咨询（TC）与面对面咨询（常规护理[UC]）的长期影响。
方法
我们招募高危女性进行一项非劣效性试验，比较TC与UC。在1057名潜在符合条件的女性中，669名被随机分配至TC组（n = 335）或UC组（n = 334），512名完成了12个月的随访。主要结局为患者报告的对基因检测决策的满意度、痛苦程度和生活质量。次要结局为癌症风险管理策略的采用情况。
结果
在所有主要结局方面，TC并不劣于UC。对决策的满意度（0.13，97.5%置信区间[CI]下限 = -0.34）未超过其1分的非劣效性界限，癌症特异性痛苦程度（-2.10，97.5% CI上限 = -0.07）未超过其4分的非劣效性界限，基因检测痛苦程度（-0.27，97.5% CI上限 = 1.46）、身体功能（0.44，97.5% CI下限 = -0.91）和心理功能（-0.04，97.5% CI下限 = -1.44）未超过其2.5分的非劣效性界限。双变量分析显示，各组间在降低风险的乳房切除术或卵巢切除术方面无差异；然而，综合来看，TC组进行降低风险手术的比例显著高于UC组（17.8%对10.5%；χ² = 4.43，P = 0.04）。
结论
研究结果支持通过电话提供遗传咨询，以扩大这项服务的可及性，且不会产生长期不良后果。
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