Effectiveness of nurse-led group CBT for hot flushes and night sweats in women with breast cancer: Results of the MENOS4 randomised controlled trial.

Troublesome hot flushes and night sweats (HFNS) are experienced by many women after treatment for breast cancer, impacting significantly on sleep and quality of life. Cognitive behavioural therapy (CBT) is known to be effective for the alleviation of HFNS. However, it is not known if it can effectively be delivered by specialist nurses. We investigated whether group CBT, delivered by breast care nurses (BCNs), can reduce the impact of HFNS. We recruited women with primary breast cancer following primary treatment with seven or more HFNS/week (including 4/10 or above on the HFNS problem rating scale), from six UK hospitals to an open, randomised, phase 3 effectiveness trial. Participants were randomised to Group CBT or usual care (UC). The primary endpoint was HFNS problem rating at 26 weeks after randomisation. Secondary outcomes included sleep, depression, anxiety and quality of life. Between 2017 and 2018, 130 participants were recruited (CBT:63, control:67). We found a 46% (6.9-3.7) reduction in the mean HFNS problem rating score from randomisation to 26 weeks in the CBT arm and a 15% (6.5-5.5) reduction in the UC arm (adjusted mean difference -1.96, CI -3.68 to -0.23, P = .039). Secondary outcomes, including frequency of HFNS, sleep, anxiety and depression all improved significantly. Our results suggest that specialist nurses can be trained to deliver CBT effectively to alleviate troublesome menopausal hot flushes in women following breast cancer in the NHS setting.

Fenlon D ，Maishman T ，Day L ，Nuttall J ，May C ，Ellis M ，Raftery J ，Turner L ，Fields J ，Griffiths G ，Hunter MS ... -  《-》

Cognitive behavioural treatment for women who have menopausal symptoms after breast cancer treatment (MENOS 1): a randomised controlled trial.

Hot flushes and night sweats (HFNS) affect 65-85% of women after breast cancer treatment; they are distressing, causing sleep problems and decreased quality of life. Hormone replacement therapy is often either undesirable or contraindicated. Safe, effective non-hormonal treatments are needed. We investigated whether cognitive behavioural therapy (CBT) can help breast cancer survivors to effectively manage HFNS. In this randomised controlled trial, we recruited women from breast clinics in London, UK, who had problematic HFNS (minimum ten problematic episodes a week) after breast-cancer treatment. Participants were randomly allocated to receive either usual care or usual care plus group CBT (1:1). Randomisation was done in blocks of 12-20 participants, stratifying by age (younger than 50 years, 50 years or older), and was done with a computer-generated sequence. The trial statistician and researchers collecting outcome measures were masked to group allocation. Group CBT comprised one 90 min session a week for 6 weeks, and included psycho-education, paced breathing, and cognitive and behavioural strategies to manage HFNS. Assessments were done at baseline, 9 weeks, and 26 weeks after randomisation. The primary outcome was the adjusted mean difference in HFNS problem rating (1-10) between CBT and usual care groups at 9 weeks after randomisation. Analysis of the primary endpoint was done by modified intention to treat. The trial is registered, ISRCTN13771934, and was closed March 15, 2011. Between May 5, 2009, and Aug 27, 2010, 96 women were randomly allocated to group CBT (n=47) or usual care (n=49). Group CBT significantly reduced HFNS problem rating at 9 weeks after randomisation compared with usual care (mean difference -1·67, 95% CI -2·43 to -0·91; p<0·0001) and improvements were maintained at 26 weeks (mean difference -1·76, -2·54 to -0·99; p<0·0001). We recorded no CBT-related adverse events. Group CBT seems to be a safe and effective treatment for women who have problematic HFNS after breast cancer treatment with additional benefits to mood, sleep, and quality of life. The treatment could be incorporated into breast cancer survivorship programmes and delivered by trained breast cancer nurses. Cancer Research UK.

Mann E ，Smith MJ ，Hellier J ，Balabanovic JA ，Hamed H ，Grunfeld EA ，Hunter MS ... -  《-》

MENOS4 trial: a multicentre randomised controlled trial (RCT) of a breast care nurse delivered cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flushes in women with breast cancer: Study Protocol.

Fenlon D ，Nuttall J ，May C ，Raftery J ，Fields J ，Kirkpatrick E ，Abab J ，Ellis M ，Rose T ，Khambhaita P ，Galanopoulou A ，Maishman T ，Haviland J ，Griffiths G ，Turner L ，Hunter M ... -  《BMC Womens Health》

A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment (MENOS 1): trial protocol.

Mann E ，Smith M ，Hellier J ，Hunter MS ... -  《BMC CANCER》

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

Hot flushes and night sweats (HFNS) are experienced by up to 80% of prostate cancer patients undergoing androgen deprivation therapy (ADT). This study evaluates the effects of a guided self-help cognitive behavioural therapy (CBT) intervention on HFNS problem-rating (primary outcome), HFNS frequency, mood and health-related quality of life (secondary outcomes) in patients undergoing ADT. Patients reporting treatment-induced HFNS were randomly assigned to CBT (n = 33) or treatment 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 completed at baseline, 6 weeks and 32 weeks after randomisation. The primary outcome was HFNS problem rating (perceived burden of HFNS) at 6 weeks after randomisation. Potential moderators and mediators were examined. Data analysis was conducted on a modified intention-to-treat basis. 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 to -1.84; p = 0.02) at 6 weeks. Improvements were maintained at 32 weeks, but group differences did not reach significance. There were significant reductions in negative HFNS Beliefs and Behaviours following CBT, but not in mood or quality of life. Guided self-help CBT appears to be a safe and effective brief treatment for men who have problematic HFNS following prostate cancer treatments. Further research might test the efficacy of the intervention in a multicentre trial.

Stefanopoulou E ，Yousaf O ，Grunfeld EA ，Hunter MS ... -  《-》