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601 The COMFORT trial: a randomised control trial comparing group-based compassion-focused therapy techniques and breathing pattern retraining with treatment as usual on the psychological functioning of patients diagnosed with cancer recurrence
  1. Sinéad Lynch1,
  2. Clodagh Finnerty2,
  3. Rachel Pender2,
  4. Damien Lowry1,
  5. Yvonne O’Meara2 and
  6. Donal Brennan2
  1. 1Mater Misericordiae University Hospital, Dublin, Ireland
  2. 2University College Dublin, Dublin, Ireland


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.

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