A randomised controlled trial of a brief cognitive behavioural intervention for men who have hot flushes following prostate cancer treatment (MANCAN)

Objective: Hot flushes and night sweats (HFNS) are experienced by up to 80%of prostate cancer patientsundergoing androgen deprivation therapy (ADT). This study evaluates the effects of a guided self-helpcognitive behavioural therapy (CBT) intervention on HFNS problem-rating (primary outcome), HFNSfrequency, mood and health-related quality of life (secondary outcomes) in patients undergoing ADT. Methods: Patients reporting treatment-induced HFNS were randomly assigned to CBT (n = 33) ortreatment as usual (TAU) (n = 35), stratified for cancer type. The CBT intervention included a booklet,CD plus telephone contact during a 4-week period. Validated self-report questionnaires were completedat baseline, 6 weeks and 32 weeks after randomisation. The primary outcome was HFNS problemrating (perceived burden of HFNS) at 6 weeks after randomisation. Potential moderators andmediators were examined. Data analysis was conducted on a modified intention-to-treat basis. Results: Compared with TAU, CBT significantly reduced HFNS problem rating (adjusted mean difference:1.33, 95% CI 2.07 to 0.58; p = 0.001) and HFNS frequency (12.12, 95% CI 22.39 to1.84; p = 0.02) at 6 weeks. Improvements were maintained at 32 weeks, but group differences did notreach significance. There were significant reductions in negative HFNS Beliefs and Behaviours followingCBT, but not in mood or quality of life. Conclusions: Guided self-help CBT appears to be a safe and effective brief treatment for men whohave problematic HFNS following prostate cancer treatments. Further research might test the efficacyof the intervention in a multicentre trial.