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混合认知行为疗法对乳腺癌、前列腺癌和结直肠癌幸存者高度复发恐惧的疗效:SWORD 研究,一项随机对照试验。

Efficacy of Blended Cognitive Behavior Therapy for High Fear of Recurrence in Breast, Prostate, and Colorectal Cancer Survivors: The SWORD Study, a Randomized Controlled Trial.

机构信息

Marieke van de Wal, Belinda Thewes, Anne Speckens, and Judith Prins, Radboud University Medical Center, Nijmegen; and Marieke Gielissen, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.

出版信息

J Clin Oncol. 2017 Jul 1;35(19):2173-2183. doi: 10.1200/JCO.2016.70.5301. Epub 2017 May 4.

Abstract

Purpose Fear of cancer recurrence (FCR) is a common problem experienced by cancer survivors. Approximately one third of survivors report high FCR. This study aimed to evaluate whether blended cognitive behavior therapy (bCBT) can reduce the severity of FCR in cancer survivors curatively treated for breast, prostate, or colorectal cancer. Patients and Methods This randomized controlled trial included 88 cancer survivors with high FCR (Cancer Worry Scale score ≥ 14) from 6 months to 5 years after cancer treatment. Participants were randomly allocated (ratio 1:1, stratified by cancer type) to receive bCBT, including five face-to face and three online sessions (n = 45) or care as usual (CAU; n = 43). Participants completed questionnaires at baseline (T0) and 3 months later (T1). The intervention group completed bCBT between T0 and T1. The primary outcome was FCR severity assessed with the Cancer Worry Scale. Secondary outcomes included other distress-related measures. Statistical (one-way between-group analyses of covariance) and clinical effects (clinically significant improvement) were analyzed by intention to treat. Results Participants who received bCBT reported significantly less FCR than those who received CAU (mean difference, -3.48; 95% CI, -4.69 to -2.28; P < .001) with a moderate-to-large effect size ( d = 0.76). Clinically significant improvement in FCR was significantly higher in the bCBT group than in the CAU group (13 [29%] of 45 compared with 0 [0%] of 43; P < .001); self-rated improvement was also higher in the bCBT group (30 [71%] of 42 compared with 12 [32%] of 38 in the CAU group; P < .001). Conclusion bCBT has a statistically and clinically significant effect on the severity of FCR in cancer survivors and is a promising new treatment approach.

摘要

目的

癌症复发恐惧(FCR)是癌症幸存者常见的问题。约有三分之一的幸存者报告存在较高的 FCR。本研究旨在评估混合认知行为疗法(bCBT)是否可以降低接受过乳腺癌、前列腺癌或结直肠癌治愈性治疗的癌症幸存者的 FCR 严重程度。

方法

这项随机对照试验纳入了 88 名癌症幸存者,他们在癌症治疗后 6 个月至 5 年内存在较高的 FCR(癌症担忧量表评分≥14)。参与者被随机分配(比例 1:1,按癌症类型分层)接受 bCBT,包括 5 次面对面和 3 次在线治疗(n=45)或常规护理(CAU;n=43)。参与者在基线(T0)和 3 个月后(T1)完成问卷。干预组在 T0 和 T1 之间接受 bCBT。主要结局是使用癌症担忧量表评估 FCR 严重程度。次要结局包括其他与困扰相关的指标。通过意向治疗分析了统计(组间协方差的单向分析)和临床效果(临床显著改善)。

结果

接受 bCBT 的参与者报告的 FCR 显著低于接受 CAU 的参与者(平均差异,-3.48;95%CI,-4.69 至-2.28;P<.001),具有中等至较大的效应量(d=0.76)。bCBT 组 FCR 的临床显著改善明显高于 CAU 组(bCBT 组 13[29%],CAU 组 0[0%];P<.001);bCBT 组自我评估的改善也更高(bCBT 组 30[71%],CAU 组 12[32%];P<.001)。

结论

bCBT 对癌症幸存者 FCR 的严重程度具有统计学和临床意义上的显著影响,是一种很有前途的新治疗方法。

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