Aims: Clinically significant fear of cancer recurrence (FCR) is common in cancer survivors, and associated with impaired quality of life (QOL) and increased healthcare usage. Using a parallel randomised controlled trial, the Conquer Fear study aimed to evaluate the impact of a theoretically-based psychological intervention in cancer survivors with clinical FCR.
Methods: Participants were disease-free Stage 0-III breast, Dukes A-C colorectal or Stage IA-IIB melanoma cancer survivors, 2 months to 5 years post-treatment, who scored above clinical cut-off (≥13) on the FCR Inventory severity subscale. Patients were randomized to: the Conquer Fear intervention (attention training, detached mindfulness, metacognitive therapy, values clarification and psycho-education), or the control intervention (relaxation training). Both interventions comprised 5 sessions, delivered by 26 therapists at 20 sites Australia-wide. Assessments were conducted at baseline, post-treatment, 3 and 6 months later. Independent samples t-tests evaluated differences in change scores between intervention and control arms for FCR (primary outcome), and secondary psychological outcomes using an intention-to-treat analysis. Target recruitment was 260 participants.
Results: Of 305 eligible and contactable patients, 222 agreed and were randomized. The groups were well matched at baseline. Participants were on average 52 years old (SD=10.1), 28 months since treatment completion, and most had breast cancer (84%). At post-treatment, intervention group participants reported an 18.1-point decrease in total FCR compared to a 7.6-point decrease in control participants (p=.0003, 95%CI -16.1, -4.9; Cohen’s d=0.44, range 0-168) and a 4.7-point decrease in the FCR severity subscale compared to a 2.4-point decrease in controls (p<.001, 95% CI -3.7, -1.0; Cohen’s d=0.40, range 0-36). Results for secondary outcomes and adjusted analyses will be presented.
Conclusions: This evidence-based psychological intervention was effective in reducing FCR in cancer survivors compared to a control treatment. The next steps will be to assess formats to increase accessibility and cost-efficacy.