Effectiveness of Two Web-Based Interventions for Chronic Cancer-Related Fatigue Compared to an Active Control Condition: Results of the "Fitter na kanker" Randomized Controlled Trial

Effectiveness of Two Web-Based Interventions for Chronic Cancer-Related Fatigue Compared to an Active Control Condition: Results of the "Fitter na kanker" Randomized Controlled Trial
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DOI:
10.2196/jmir.7180
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发表时间:
2017-10-01
影响因子:
7.4
通讯作者:
Van der Lee, Marije L.
Van der Lee, Marije L.
中科院分区:
医学2区
文献类型:
--
作者:
Bruggeman-Everts, Fieke Z.;Wolvers, Marije D. J.;Van der Lee, Marije L.

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背景:在所有已成功治疗癌症的患者中,大约三分之一患有慢性癌症相关疲劳(CCRF)。这些患者需要有效且易于获得的干预措施。 目的:本文报告了一项三组随机对照试验的结果,该试验调查了两种不同的基于网络的引导干预措施与主动对照条件相比减少 CCRF 的临床有效性。 方法:通过线上和线下渠道招募严重疲劳的癌症幸存者,并在开放访问网站上自行注册。经过资格检查后,167 名参与者通过嵌入式自动随机化功能被随机分配到:(1) 物理治疗师指导的移动活动反馈 (AAF) 治疗,包括使用加速度计 (n=62); (2) 心理学家指导的基于网络的正念认知疗法(eMBCT;n=55); (3) 接收心理教育电子邮件的无指导主动控制条件 (n=50)。所有干预持续九周。从基线 (T0b) 到六个月 (T2),使用个人力量检查表 - 疲劳严重程度子量表(主要结果)对疲劳严重程度进行六次自我评估。使用医院焦虑和抑郁量表以及积极和消极影响表(次要结果)对心理健康进行三次自我评估。对治疗退出进行了调查。结果:多组潜在生长曲线分析(根据评估之间的个体时间进行校正)表明,与心理教育组相比,AAF 和 eMBCT 组的疲劳严重程度显着降低。这些分析是由一位对分配情况视而不见的研究人员检查的。在 AAF 中 66% (41/62) 的患者、eMBCT 中 49% (27/55) 的患者以及心理教育中 12% (6/50) 的患者中观察到疲劳严重程度的临床相关变化。 AAF 中的辍学率为 18% (11/62),主要是由于技术问题和加速度计可用性差;而 eMBCT 中的辍学率为 38% (21/55),主要是由于人们认为该计划强度较高。结论:与接收心理教育电子邮件相比,AAF 和 eMBCT 干预措施对于管理疲劳严重程度都有效。
Background: Approximately one third of all patients who have been successfully treated for cancer suffer from chronic cancer-related fatigue (CCRF). Effective and easily accessible interventions are needed for these patients.Objective: The current paper reports on the results of a 3-armed randomized controlled trial investigating the clinical effectiveness of two different guided Web-based interventions for reducing CCRF compared to an active control condition.Methods: Severely fatigued cancer survivors were recruited via online and offline channels, and self-registered on an open-access website. After eligibility checks, 167 participants were randomized via an embedded automated randomization function into: (1) physiotherapist-guided Ambulant Activity Feedback (AAF) therapy encompassing the use of an accelerometer (n=62); (2) psychologist-guided Web-based mindfulness-based cognitive therapy (eMBCT; n=55); or (3) an unguided active control condition receiving psycho-educational emails (n=50). All interventions lasted nine weeks. Fatigue severity was self-assessed using the Checklist Individual Strength - Fatigue Severity subscale (primary outcome) six times from baseline (T0b) to six months (T2). Mental health was self-assessed three times using the Hospital Anxiety and Depression Scale and Positive and Negative Affect Schedule (secondary outcome). Treatment dropout was investigated.Results: Multiple group latent growth curve analysis, corrected for individual time between assessments, showed that fatigue severity decreased significantly more in the AAF and eMBCT groups compared to the psycho-educational group. The analyses were checked by a researcher who was blind to allocation. Clinically relevant changes in fatigue severity were observed in 66% (41/62) of patients in AAF, 49% (27/55) of patients in eMBCT, and 12% (6/50) of patients in psycho-education. Dropout was 18% (11/62) in AAF, mainly due to technical problems and poor usability of the accelerometer, and 38% (21/55) in eMBCT, mainly due to the perceived high intensity of the program.Conclusions: Both the AAF and eMBCT interventions are effective for managing fatigue severity compared to receiving psycho-educational emails.