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Abstract
Introduction/Background Cancer patients suffer from heightened levels of psychological distress when diagnosed with recurrent disease. The role of online psychological interventions to address distress induced by diagnosis of a recurrence has not been evaluated in a randomised control trial. The purpose of this trial is to demonstrate the effectiveness of an online intervention combining compassion focused therapy (CFT) techniques with breathing pattern retraining (BPR) over a 6-week period to reduce psychological distress.
Methodology 160 patients with confirmed recurrent disease and Distress Thermometer (DT) score >/= 4 or higher were enrolled and randomly allocated to receive either a 6-week, online, CFT and BPR group intervention or treatment as usual. The primary outcome was a clinically significant, 1 unit change in DT score at 18 weeks. A linear mixed effects model was used to compare change from baseline between arms, accounting for repeated measures within individuals. A random intercepts model was used, with categorical time, arm, and time x arm interaction as fixed effects.
Results 160 patients enrolled and 124 completed the protocol. The mean age of participants was 59(SD-14). 50% of participants had breast or gynaecological cancer. 76% of patients enrolled on first recurrence. Patient demographics were well matched between groups. Linear mixed-effects model and intent-to-treat analyses demonstrated a mean difference in the improvement from baseline to 18 weeks of 1.09 units (95% CI: 0.24, 1.95) (p=0.013) on the DT scale in the intervention group, consistent with the pre-specified minimum clinically significant difference (Figure 1). The TAU group showed no significant change in DT scores.
Conclusion In the largest trial to date, CFT & BPR was significantly superior in reducing distress in patients with recurrent cancer compared with TAU. The COMFORT trial demonstrates that a psychological intervention met its primary objective of distress amelioration 18 weeks post-intervention and established the feasibility of online delivery.
Disclosures The authors declare no potential conflicts of interest.
