ConquerFear-Group: A randomized controlled trial of an online-delivered group-based psychological intervention for fear of cancer recurrence in breast cancer survivors.

Abstract

Fear of cancer recurrence (FCR) is a distressing concern among cancer survivors. Interventions to address FCR need to be effective but also accessible and low cost. This randomized controlled trial evaluated the efficacy of an online group-based psychological intervention for FCR (ConquerFear-Group). Eligible breast cancer (BC) survivors had completed primary treatment 3months-5years previously, were ≥18years, and scored ≥22 on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). Participants were randomized to online ConquerFear-Group (focusing on metacognitive strategies, values-clarification, and education about follow-up behavior) or online group-based relaxation training (active control). Questionnaires were completed at baseline (T1), 1week post-intervention (T2), three (T3) and six (T4) months later. The primary outcome was FCR (FCRI total). A number of secondary and process outcomes were also collected. Treatment effects were evaluated with mixed linear models. Of 866 eligible BC survivors, 475 (55%) completed the FCR screening, and 85 (18%) were randomized to ConquerFear-Group or relaxation training (2×6 groups). Compared with control participants, ConquerFear-Group participants experienced larger reductions in FCR (Cohen's d=0.47, p=0.001) and FCR severity (d=0.57, p<0.001), as well as mindfulness and decentering from baseline through follow-up, and improvements in emotion regulation (T2), worry (T2, T3) and rumination (T2) at some time points. The results demonstrated statistically significant and stable effects of ConquerFear-Group on FCR that were maintained over a 6-month period. It is suggested to investigate the program in a real-life setting, where a pragmatic trial can further demonstrate feasibility and effectiveness.