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. 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). 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. ClinicalTrials.gov; NCT04287218, registered 25.02.2020. https://clinicaltrials.gov/ct2/results?cond=&term=NCT04287218&cntry=&state=&city=&dist=.

中文翻译：

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研究方案：一项随机对照试验，比较治疗师引导的互联网认知疗法 (TG-iConquerFear) 与常规增强治疗在减少丹麦结直肠癌幸存者对癌症复发的恐惧方面的功效


认知疗法已被证明可以减少对癌症复发（FCR）的恐惧，尤其是乳腺癌幸存者。认知行为干预的可及性可以通过互联网进一步提高，但自我引导的干预效果有限。本研究的目的是测试治疗师引导的互联网干预 (TG-iConquerFear) 与常规强化治疗 (aTAU) 对丹麦结直肠癌幸存者的疗效。一项基于人群的随机对照试验 (RCT)，在 n = 246 名患有临床显着 FCR（癌症复发恐惧清单简表 (FCRI-SF) ≥ 22 和半结构化面试）。评估将在治疗后2周、3个月和6个月进行，并评估组间差异。长期影响将在一年后进行评估。主要结果是治疗后 FCR (FCRI-SF)。次要结局是全球总体健康和全球生活质量（视觉模拟量表 0-100）、身体不适综合症（BDS 检查表）、健康焦虑（Whiteley-6）、焦虑（SCL4-anx）、抑郁（SCL6-dep）和因病缺勤和医疗支出（登记数据）。解释性结果包括：疾病的不确定性（Mishels 疾病不确定性量表，简称 MUIS）、元认知（MCQ-30 关于忧虑量表的负面信念）和感知的癌症复发风险（视觉模拟量表 1-100）。该随机对照试验将为具有临床 FCR 的 CRC 幸存者提供有关 TG-iConquerFear 与 aTAU 的临床和成本效益的宝贵信息，以及可能充当结果调节因素或中介因素的解释变量。临床试验.gov； NCT04287218，注册于 2020 年 2 月 25 日。 https://临床试验。gov/ct2/结果？cond=&term=NCT04287218&cntry=&state=&city=&dist=。