Abstract
BackgroundCognitive 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/designA 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).DiscussionThis 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 registrationClinicalTrials.gov; NCT04287218, registered 25.02.2020.https://clinicaltrials.gov/ct2/results?cond=&term=NCT04287218&cntry=&state=&city=&dist=.
Highlights
Cognitive therapy has been shown to reduce fear of cancer recurrence (FCR), mainly in breast cancer survivors
Lyhne et al BMC Cancer (2020) 20:223 (Continued from previous page). This randomized controlled trial (RCT) will provide valuable information on the clinical and cost-effectiveness of TG-iConquerFear vs. augmented treatment as usual (aTAU) for Colorectal Cancer (CRC) survivors with clinical FCR, as well as explanatory variables that may act as outcome moderators or mediators
Aim The primary aim of this RCT is to test if a therapistguided version of iConquerFear (TG-iConquerFear) can reduce FCR and improve QoL for CRC survivors more than augmented treatment as usual
Summary
Cognitive therapy has been shown to reduce fear of cancer recurrence (FCR), mainly in breast cancer survivors. Colorectal cancer (CRC) screening, early detection, and improved treatment have led to rising survival rates over the past decades. This improvement has resulted in an increasing number of long-term CRC survivors with no residual disease. One of the most common concerns among cancer survivors is fear of cancer recurrence (FCR) [2], defined as “Fear, worry or concern relating to the possibility that cancer will come back or progress [3]”. Higher FCR is associated with multiple psychological factors including (health) anxiety [6], depression [7], greater uncertainty in illness, perceived risk of recurrence and negative beliefs about worry [8]. An expert consensus on the defining features of clinical FCR suggested, that the following four features are key characteristics of clinical FCR: a) high levels of preoccupation; b) high levels of worry; c) that are persistent; and d) hypervigilance to bodily symptoms [9]
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