Purpose: Despite the availability of effective interventions, fear of cancer recurrence (FCR) remains a prevalent concern among cancer survivors, underscoring the need for more accessible approaches. This trial aimed to assess the efficacy of a 10-week therapist-guided (TG) eHealth intervention, TG-iConquerFear.
Methods: This randomized controlled trial enrolled adult colorectal cancer survivors (CRCS) who had completed curative-intented treatment between March 2014 and December 2018, and reported Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) scores ≥22. Eligible participants were randomized to TG-iConquerFear or web-based self-help exercises. Guidance were delivered asynchronously and in written. The predefined primary outcome was the between-group difference in FCRI total score change at three months post-intervention (T2), analyzed according to intention-to-treat.
Results: Of 9,946 eligible CRCS, 5,515 (55%) completed FCR screening, and 299 (5%) reported clinically significant FCR. 103 (47%) were randomized to TG-iConquerFear (n=49) or augmented control (n=54). Main reasons for non-inclusion included new cancer diagnoses (n=34) or FCR not affecting everyday life (n=32). Participants completed 4.5 out of 6 modules on average. Total FCRI score decreased more from baseline to T2 in the TG-iConquerFear group (mean -21.7, 95% CI [-30.1, -13.3]) compared to the self-help group (mean -2.6 95% CI [-7.8, 2.6]). This represents a between-group difference at T2 of 19.1 (95% CI [10.0, 28.3], p < 0.001) and a standardized effect size (Cohen’s d) of 0.62 (95% CI [0.13 - 1.1]). A significantly higher proportion of TG-iConquerFear participants were in the non-clinical range at T2 compared to self-help participants (81.5% vs. 42.9%, p = 0.002). Number needed to treat was n=3.
Conclusions: The TG-iConquerFear intervention demonstrated a statistically and clinically significant reduction in FCR in a population of long-term CRCS.