研究方案：一项随机对照试验，比较治疗师指导的互联网认知疗法（TG-iConquerFear）与增强的常规治疗在降低丹麦结直肠癌幸存者对癌症复发恐惧方面的疗效。
Study protocol: a randomized controlled trial comparing the efficacy of therapist guided internet-delivered cognitive therapy (TG-iConquerFear) with augmented treatment as usual in reducing fear of cancer recurrence in Danish colorectal cancer survivors.
机构信息
Department of Clinical Oncology, University Hospital of Southern Denmark, Vejle, Beriderbakken 4, 7100, Vejle, Denmark.
Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool, NSW, 2170, Australia.
出版信息
BMC Cancer. 2020 Mar 16;20(1):223. doi: 10.1186/s12885-020-06731-6.
BACKGROUND
Cognitive therapy has been shown to reduce fear of cancer recurrence (FCR), mainly in breast cancer survivors. The accessibility of cognitive behavioural interventions could be further improved by Internet delivery, but self-guided interventions have shown limited efficacy. The aim of this study is to test the efficacy of a therapist guided internet-delivered intervention (TG-iConquerFear) vs. augmented treatment as usual (aTAU) in Danish colorectal cancer survivors.
METHODS/DESIGN: A population-based randomized controlled trial (RCT) comparing TG-iConquerFear with aTAU (1:1) in n = 246 colorectal cancer survivors who suffer from clinically significant FCR (Fear of Cancer Recurrence Inventory Short Form (FCRI-SF) ≥ 22 and semi-structured interview). Evaluation will be conducted at 2 weeks, 3 and 6 months post-treatment and between-group differences will be evaluated. Long-term effects will be evaluated after one year. Primary outcome will be post-treatment FCR (FCRI-SF). Secondary outcomes are global overall health and global quality of life (Visual Analogue Scales 0-100), bodily distress syndrome (BDS checklist), health anxiety (Whiteley-6), anxiety (SCL4-anx), depression (SCL6-dep) and sickness absence and health expenditure (register data). Explanatory outcomes include: Uncertainty in illness (Mishels uncertainty of illness scale, short form, MUIS), metacognitions (MCQ-30 negative beliefs about worry subscale), and perceived risk of cancer recurrence (Visual analogue Scale 1-100).
DISCUSSION
This RCT will provide valuable information on the clinical and cost-effectiveness of TG-iConquerFear vs. aTAU for CRC survivors with clinical FCR, as well as explanatory variables that may act as outcome moderators or mediators.
TRIAL REGISTRATION
ClinicalTrials.gov; NCT04287218, registered 25.02.2020. https://clinicaltrials.gov/ct2/results?cond=&term=NCT04287218&cntry=&state=&city=&dist=.
背景
认知疗法已被证明可以降低癌症复发恐惧（FCR），主要针对乳腺癌幸存者。通过互联网提供认知行为干预措施可以进一步提高其可及性，但自我指导的干预措施显示出有限的疗效。本研究旨在测试治疗师指导的互联网干预（TG-iConquerFear）与增强的常规治疗（aTAU）在丹麦结直肠癌幸存者中的疗效。
方法/设计：这是一项基于人群的随机对照试验（RCT），比较 TG-iConquerFear 与 aTAU（1:1）在 n=246 名患有临床显著 FCR（癌症复发恐惧量表短表（FCRI-SF）≥22 分和半结构化访谈）的结直肠癌幸存者中的效果。将在治疗后 2 周、3 个月和 6 个月进行评估，并评估组间差异。一年后评估长期效果。主要结局是治疗后 FCR（FCRI-SF）。次要结局是整体健康和整体生活质量（0-100 分视觉模拟量表）、躯体困扰综合征（BDS 检查表）、健康焦虑（Whiteley-6）、焦虑（SCL4-anx）、抑郁（SCL6-dep）和病假和健康支出（登记数据）。解释性结局包括：疾病不确定性（Mishels 疾病不确定性量表，短表，MUIS）、元认知（MCQ-30 担忧负信念量表）和癌症复发的感知风险（1-100 分视觉模拟量表）。
讨论
本 RCT 将提供有关 TG-iConquerFear 与 aTAU 对结直肠癌幸存者临床 FCR 的临床和成本效益的有价值的信息，以及可能作为结局调节剂或中介的解释性变量。
试验注册
ClinicalTrials.gov；NCT04287218，于 2020 年 2 月 25 日注册。https://clinicaltrials.gov/ct2/results?cond=&term=NCT04287218&cntry=&state=&city=&dist=。
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