BRCA1/2基因咨询电话服务与面对面咨询的随机非劣效性试验：1年随访
Randomized Noninferiority Trial of Telephone Delivery of BRCA1/2 Genetic Counseling Compared With In-Person Counseling: 1-Year Follow-Up.
作者信息
Kinney Anita Y, Steffen Laurie E, Brumbach Barbara H, Kohlmann Wendy, Du Ruofei, Lee Ji-Hyun, Gammon Amanda, Butler Karin, Buys Saundra S, Stroup Antoinette M, Campo Rebecca A, Flores Kristina G, Mandelblatt Jeanne S, Schwartz Marc D
机构信息
Anita Y. Kinney, Laurie E. Steffen, Barbara H. Brumbach, Ruofei Du, Ji-Hyun Lee, Karin Butler, and Kristina G. Flores, University of New Mexico, Albuquerque, NM; Wendy Kohlmann, Amanda Gammon, and Saundra S. Buys, University of Utah, Salt Lake City, UT; Antoinette M. Stroup, Rutgers, The State University of New Jersey, New Brunswick, NJ; Rebecca A. Campo, University of North Carolina at Chapel Hill, Chapel Hill, NC; and Jeanne S. Mandelblatt and Marc D. Schwartz, Georgetown University, Washington, DC.
出版信息
J Clin Oncol. 2016 Aug 20;34(24):2914-24. doi: 10.1200/JCO.2015.65.9557. Epub 2016 Jun 20.
PURPOSE
The ongoing integration of cancer genomic testing into routine clinical care has led to increased demand for cancer genetic services. To meet this demand, there is an urgent need to enhance the accessibility and reach of such services, while ensuring comparable care delivery outcomes. This randomized trial compared 1-year outcomes for telephone genetic counseling with in-person counseling among women at risk of hereditary breast and/or ovarian cancer living in geographically diverse areas.
PATIENTS AND METHODS
Using population-based sampling, women at increased risk of hereditary breast and/or ovarian cancer were randomly assigned to in-person (n = 495) or telephone genetic counseling (n = 493). One-sided 97.5% CIs were used to estimate the noninferiority effects of telephone counseling on 1-year psychosocial, decision-making, and quality-of-life outcomes. Differences in test-uptake proportions for determining equivalency of a 10% prespecified margin were evaluated by 95% CIs.
RESULTS
At the 1-year follow-up, telephone counseling was noninferior to in-person counseling for all psychosocial and informed decision-making outcomes: anxiety (difference [d], 0.08; upper bound 97.5% CI, 0.45), cancer-specific distress (d, 0.66; upper bound 97.5% CI, 2.28), perceived personal control (d, -0.01; lower bound 97.5% CI, -0.06), and decisional conflict (d, -0.12; upper bound 97.5% CI, 2.03). Test uptake was lower for telephone counseling (27.9%) than in-person counseling (37.3%), with the difference of 9.4% (95% CI, 2.2% to 16.8%). Uptake was appreciably higher for rural compared with urban dwellers in both counseling arms.
CONCLUSION
Although telephone counseling led to lower testing uptake, our findings suggest that telephone counseling can be effectively used to increase reach and access without long-term adverse psychosocial consequences. Further work is needed to determine long-term adherence to risk management guidelines and effective strategies to boost utilization of primary and secondary preventive strategies.
目的
癌症基因组检测正不断融入常规临床护理，这使得对癌症遗传服务的需求增加。为满足这一需求，迫切需要提高此类服务的可及性和覆盖范围，同时确保提供可比的护理效果。这项随机试验比较了针对居住在不同地理区域的遗传性乳腺癌和/或卵巢癌高危女性，电话遗传咨询与面对面咨询的1年结果。
患者与方法
采用基于人群的抽样方法，将遗传性乳腺癌和/或卵巢癌风险增加的女性随机分配至面对面咨询组（n = 495）或电话遗传咨询组（n = 493）。使用单侧97.5%置信区间来估计电话咨询对1年心理社会、决策和生活质量结果的非劣效性影响。通过95%置信区间评估用于确定10%预设差值等效性的检测接受比例差异。
结果
在1年随访时，对于所有心理社会和知情决策结果，电话咨询不劣于面对面咨询：焦虑（差值[d]，0.08；97.5%置信区间上限，0.45）、癌症特异性困扰（d，0.66；97.5%置信区间上限，2.28）、感知个人控制（d， -0.01；97.5%置信区间下限， -0.06）和决策冲突（d， -0.12；97.5%置信区间上限，2.03）。电话咨询的检测接受率（27.9%）低于面对面咨询（37.3%），差值为9.4%（95%置信区间，2.2%至16.8%）。在两个咨询组中，农村居民的接受率明显高于城市居民。
结论
尽管电话咨询导致检测接受率较低，但我们的研究结果表明，电话咨询可有效用于扩大覆盖范围和可及性，且不会产生长期不良心理社会后果。需要进一步开展工作来确定对风险管理指南的长期依从性以及提高一级和二级预防策略利用率的有效策略。
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