MANCAN2: A multicentre randomised controlled trial of self-help cognitive behavioural therapy (CBT) to manage hot flush and night sweats (HFNS) symptoms in patients with prostate cancer receiving androgen deprivation therapy (ADT).
Authors: Simon J. Crabb, Alannah Morgan, Evgenia Stefanopoulou, Louisa Fleure, James Raftery, Gareth Owen Griffiths, Cherish Boxall, Sam Wilding, Theodora Nearchou, Sean Ewings, Jacqueline Nuttall, Zina Eminton, Emma Tilt, Roger Bacon, Jonathan Martin, Deborah Fenlon, Myra Hunter, Alison Richardson
Journal: Journal of Clinical Oncology (2024)

LBA5004 Background: Up to 80% of patients receiving ADT suffer HFNS which impacts quality of life (QOL) and potentially ADT compliance. Mitigation options are limited. Prior research has found self-help CBT, with minimal guidance, reduced HFNS due to ADT at 6 weeks. We tested the longer term impact of self-help CBT, guided and delivered by prostate Cancer Nurse Specialist (CNS) teams. Methods: MANCAN2 is a multicentre randomised controlled trial and process evaluation within UK prostate cancer units. Eligibility: localised/advanced prostate cancer; on ADT with ≥ 6 months further planned; HFNS Problem Rating Scale ≥ 2. Patients were randomised (1:1) in groups of 6 to 8 to treatment as usual (TAU) or CBT + TAU, by permuted block, stratified by site, cohort and treatment intent. CBT was a 4-week self-help intervention (booklet and relaxation audio) with pre- and post-intervention group workshops by the prostate CNS team. Primary objective: does adding CBT to TAU reduce 6 month HFNS Problem Rating Scale versus baseline (mixed linear regression). Secondary endpoints: 6 week HFNS Problem Rating Scale, HFNS frequency, HFNS beliefs and behaviours, QOL (EORTC QLQ-C30, symptoms (rating scales for anxiety, depression, mood and sleep) by mixed logistic regression), ADT compliance (chi-squared test). A 6 month mean HFNS Problem Rating Scale difference of ≥ 1.5 points was deemed clinically relevant, and required data from 111 patients (90% power, 5% type 1 error, 6 to 8 patients per group, intra-class correlation 0.01, anticipating 26% patient loss). Results: 162 patients were randomly assigned (81/arm) and 117 returned 6 month HFNS Problem Rating Scale data. Baseline characteristics were balanced. Mean CBT delivery adherence was 85%. 6 month mean HFNS Problem Rating Scale score was not significantly different for the TAU alone versus CBT + TAU (mean 4.08 vs 4.04, 95% CI for difference: -0.89, 0.80; p=0.97), although a difference was observed at 6 weeks (mean 4.47 vs 3.79, 95% CI: -1.26, -0.09; p=0.03). At 6 weeks, CBT patients had higher weekly HFNS frequency (median 54.2 vs 59.4, 95% CI: 0.22, 10.19; p=0.04), lower depression score (median 7.19 vs 6.19, 95% CI: -1.88, -0.12; p=0.03) and lower anxiety score (median 4.25 vs 3.39, 95% CI: -1.64, -0.08; p=0.03). CBT patients had more positive beliefs about openness and humour scores at 6 months (median 4.92 vs 4.59, 95% CI: -0.63, -0.03; p=0.03). There was no significant difference for other measures of HFNS beliefs and behaviours, quality of life, anxiety, mood, sleep quality and treatment compliance. Conclusions: Adding CBT to TAU in prostate cancer patients receiving ADT improved short-term HFNS severity but was not maintained at 6 months. Future research should investigate whether initial CBT benefit could be made sustainable in this setting. Clinical trial information: 58720120.