Treatment and follow-up visits
breathing cognitive, sweats, prostate
PROSTATE
Participants are individually randomised (1:1), within groups, to receive TAU plus a guided self-help cognitive behavioural intervention (CBT) or TAU alone. Patients will be randomised by a trial statistician at Southampton Clinical Trials Unit using a pre-generated permuted block method which is stratified by cohort and treatment (curative or palliative). Treatment allocation is unblinded. Sites are informed of the randomisation results via email within 1 day of randomisation, who then contact the patients to discuss study procedures.Men randomised to the TAU plus guided self-help CBT arm receive a 4-week self-help treatment schedule. The intervention content comprises an instructional self-help booklet (electronic and paper copies available) including information and exercises addressing stress management, paced breathing cognitive and behavioural strategies to improve wellbeing, managing their hot flushes, night sweats and sleep, and a downloadable MP3 audio (and a CD) demonstrating breathing and relaxation exercises. Additionally, participants are invited to participate in two group workshops that are delivered by trained members of the existing prostate CNS team. Sites can deliver workshops in a face-to-face group setting, virtually, or a hybrid approach. The choice of workshop delivery method is at the local CNS team discretion. Workshop 1 takes place during week 1 of the intervention (day 0) and offers practical help on how to use the self-help CBT guide (booklet) appropriately and provide participants with an opportunity to meet other men experiencing similar symptoms. Workshop 2 takes place during week 4 of the intervention with focus on practical tips and strategies to help participants maintain their practice in the future.Day 0 is defined as the date of workshop 1 for all randomised participants in that cohort. Follow-up questionnaires are posted, from SCTU, to all participants for completion at 6 weeks and 6 months. Where questionnaires have not been returned within 10 days, participants are contacted by telephone and primary outcome data may be collected by telephone. A 1:1 randomised study within a trial (SWAT) is included to explore whether a theory-based cover letter improves the 6-month paper questionnaire return rate. Men randomised to the intervention arm complete a patient evaluation questionnaire following workshop 2.