Discussion
cancer
CANCER RECURRENCE, CANCER, RECRUITMENT, SECONDARY, BLIND
This paper describes the protocol of the COMFORT trial, a RCT comparing the effectiveness of an online, group-based, compassion-focussed therapy (CFT) psychological intervention combined with breathing pattern retraining (BPR), to those receiving standard medical care only, at reducing psychological distress in adults experiencing cancer recurrence during COVID-19. We have endeavoured to enhance the quality of research in the area of hospital-based, psycho-oncology, particularly as it continues to develop in the Irish context. The inclusion criteria for the study are relatively broad, in an effort to capture a representative sample and with the aim of maximising the generalisability of the findings.There are a number of limitations inherent in this trial, most prominently the inability to blind study participants and clinicians to treatment allocation. We have attempted to address issues of additional biases as far as has been practically possible through the provision of randomisation and concealment of allocation, strategies to minimise and manage incomplete outcome data, the delivery of a specialist combined intervention by an experienced senior psychologist specialising in psycho-oncology and BPR, the recruitment of an adequate sample size and having appropriate duration of follow-up and a priori specification of all primary and secondary outcomes as detailed in this study protocol. We have also traded the reported downside of a virtual group (reduced social interaction with and support from fellow peers) off against this platform removing a potential geographical boundary for some individuals unable to commute to Dublin on a regular basis.To our knowledge, this will be the first RCT to assess the effectiveness of a combined psychological and breathing pattern retraining intervention for cancer recurrence. The study results will add to current knowledge in the field of psycho-oncology and general cancer management and will have the potential to inform the delivery of best-practice treatments for cancer patients.