Self-help cognitive behavioural therapy for hot flushes and night sweats during androgen deprivation therapy for prostate cancer: the MANCAN2 randomized controlled trial

BACKGROUND: Androgen deprivation therapy (ADT) causes hot flushes and night sweats (HFNS) and is associated with sleep disturbance, anxiety, low mood and cognitive impairment. We tested self-help cognitive behavioural therapy (CBT), when guided by prostate cancer nurse specialist teams, for mitigation of the long-term impact of HFNS, and associated symptoms. METHODS: Prostate cancer patients receiving ADT, with a HFNS Problem Rating Scale ≥2, were randomised (1:1) to treatment as usual (TAU) or CBT + TAU, stratified by centre and treatment intent. CBT was a 4-week self-help intervention with pre- and post-intervention group workshops guided by trained prostate cancer nurse specialists. PRIMARY ENDPOINT: 6-month HFNS Problem Rating Scale. Secondary endpoints included HFNS frequency, ADT compliance and rating scales for HFNS beliefs and behaviours, quality of life, anxiety, depression and sleep. RESULTS: 162 patients were randomised. 6 month mean HFNS Problem Rating Scale score was not significantly different between the TAU and CBT + TAU groups (mean 4.08 vs 4.04, 95% confidence interval (CI) for difference: -0.89, 0.80; p = 0.97), although was improved at 6 weeks (mean 4.47 vs 3.79, 95% CI: -1.26, -0.09; p = 0.03), when depression, anxiety scores and ADT compliance also favoured CBT + TAU. CONCLUSIONS: The addition of CBT in prostate cancer patients receiving ADT improved short-term HFNS severity, in addition to improved anxiety and depression scores, but these were not maintained at 6 months. CLINICAL TRIAL REGISTRATION: ISRCTN58720120.