Simon J. Crabb, Alannah Morgan, Evgenia Stefanopoulou, Louisa Fleure, Gareth Griffiths, Cherish Boxall, Sam Wilding, Theodora Nearchou, Sean Ewings, Jacqueline Nuttall, Zina Eminton, Emma Tilt, Emma whitby, Bernard Siu, Paul Ridley, Lynsey Robson, Jenny Nobes, Joanne Preece, Roger Bacon, Jonathan Martin, Sarah Chamberlain, Deborah Fenlon, Myra S. Hunter, Alison Richardson
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.