Aims: This presentation describes a novel intervention designed to reduce fear of cancer recurrence (FCR), based on the Self-Regulatory Executive Function Model and Relational Frame Theory. The presentation includes pilot data and description of a current randomised controlled trial (RCT).
Methods: Eight patients with high FCR participated in the pilot study, receiving five manual-based sessions comprising introduction to the model, identification of vulnerability factors, attention training, detached mindfulness, and advice on healthy living and managing worry. This pilot study formed the basis for the RCT being conducted at 12 clinical sites. Eligible patients who have completed treatment for Stage 0-III breast, I-IIB/IIIA colorectal cancer, or 1A-IIB melanoma between 2 months and five years prior to study entry are randomised to the intervention (Conquer Fear) or a relaxation control arm (Taking it Easy). Conquer Fear and Taking it Easy are manual-based and each comprise five sessions, delivered by a therapist (psychologist or psychiatrist) with at least two years’ clinical experience who participates in day-long training and receives monthly supervision. The primary outcome is Fear of Cancer Recurrence (Fear of Cancer Recurrence Inventory, FCRI). Secondary outcomes include Cancer Specific Distress (Impact of Events Scale, IES) and Quality of Life (AQoL 8D). The study includes a cost-consequences analysis.
Results: At two-month follow-up, participants in the pilot study had reductions of 8.2 points on the 36-point FCRI (Severity subscale) (p = 0.002; effect size = 1.9) and 17.7 points on the 75-point IES (p = 0.03; effect size = 1.2). The RCT has recruited and trained twenty-five therapists. Of a calculated sample size of 234, 96 patients have been recruited of whom 55 have been randomised to Conquer Fear and 41 to Taking it Easy.
Conclusion: Initial results indicate that this model is acceptable to patients with potential to reduce clinically-significant FCR.