Eleanor Mann

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

Summary Background 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. Methods 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. Findings 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. Interpretation 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. Funding Cancer Research UK.

A cognitive model of menopausal hot flushes and night sweats

Hot flushes and night sweats (HF/NS) are commonly experienced by mid-aged women during the menopause transition. They affect approximately 70% of women but are regarded as problematic for 15-20% largely due to physical discomfort, distress, social embarrassment, and sleep disturbance. There is a need for effective and acceptable nonmedical treatments for menopausal symptoms due to the declining use of hormone therapy (HT) following publication of the Womens Health Initiative and other prospective studies which associated HT use with increased risk of stroke and breast cancer. HF/NS are an example of a physiological process embedded within, and moderated by, psychological processes, as evidenced by discrepancies between subjective experiences and physiologically measured symptoms. We describe a cognitive model of menopausal hot flushes that can explain symptom perception, cognitive appraisal, and behavioral reactions to symptoms. Theoretically, the model draws on symptom perception theory, self-regulation theory, and cognitive behavioral theories. The model can be used to identify the variables to target in psychological interventions for HF/NS and to aid understanding of possible mediating factors. As part of Phase II intervention development, we describe a cognitive behavioral treatment which links the bio-psycho-social processes specified in the model to components of the intervention.

Effectiveness of group and self-help cognitive behavior therapy in reducing problematic menopausal hot flushes and night sweats (MENOS 2): a randomized controlled trial

Objective The aim of this study was to examine the effectiveness of group cognitive behavioral therapy (CBT) and guided self-help CBT in reducing hot flush and night sweat (HF/NS) problem rating at 6 and 26 weeks after randomization. Methods This was a randomized control trial of 140 women having 10 or more problematic HF/NS a week for at least a month. The primary outcome was HF/NS problem rating (1-10) at 6 weeks after randomization. Secondary outcomes were physiologically measured HF/NS at 6 weeks; HF/NS problem rating at 6 weeks; and frequency, mood (Women’s Health Questionnaire), and health-related quality of life (General Health Survey Short Form–36) at 6 and 26 weeks. Intention-to-treat analysis was used, and between-group differences were estimated using linear mixed models. Results Baseline mean (SD) HF/NS weekly frequency was 63.15 (49.24), and problem rating was 5.87 (2.28). Group and self-help CBT both significantly reduced HF/NS problem rating at 6 weeks—group CBT versus no treatment control (NTC; adjusted mean difference, 2.12; 95% CI, 1.36-2.88; P < 0.001) and self-help CBT versus NTC (adjusted mean difference, 2.08; 95% CI, 1.29-2.86; P < 0.001)—and at 26 weeks—group CBT versus NTC (adjusted mean difference, 1.33; 95% CI, 0.54-2.13; P = 0.001) and self-help CBT versus NTC (adjusted mean difference, 1.19; 95% CI, 0.36-2.02; P = 0.005). Group and self-help CBT significantly reduced night sweat frequency at 6 and 26 weeks. There were improvements in mood and quality of life at 6 weeks and improved emotional and physical functioning for group CBT at 26 weeks. Conclusions These results suggest that CBT delivered in group or self-help format is an effective treatment option for women during the menopause transition and postmenopause with problematic HF/NS.

Concordance between self-reported and sternal skin conductance measures of hot flushes in symptomatic perimenopausal and postmenopausal women: a systematic review

Objective:Sternal skin conductance is considered the gold standard in hot flush and night sweat measurement, but results sometimes differ from womens own self-reports. To date, there has been no systematic review of concordance between sternal skin conductance and self-report measures. An exploratory meta-analysis was conducted to quantify concordance between these measures and to explore the reasons for discordance between them. Methods:A search of Medline, EMBASE, Web of Science, and PsychInfo from inception to December 2009 was conducted. Studies that measured self-reported hot flushes and/or night sweats and sternal skin conductance concurrently in symptomatic perimenopausal and postmenopausal women were retained for data extraction. Studies were included if data on concordance between the two measures were available. Results:Concordance rates overall were 29%, but variability between studies was too broad to identify a single typical concordance rate. However, concordance rates for ambulatory monitoring were more homogeneous and also had a 29% concordance rate. Nonambulatory studies tended to result in more concordant hot flushes (54%) than ambulatory studies did, and night sweats tended to be under-reported more often than over-reported (46% and 22%, respectively). Conclusions:Concordance rates were typically lower than early reports of sternal skin conductance measures but were highly variable between studies. Possible measurement error and study conditions might partly explain the discordance and variation in study findings, but further exploration of the effects of symptom perception is warranted. Use of both measures concurrently is likely to achieve more reliable and valid measurement of hot flushes and night sweats than either measure alone.

Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): randomised trial.

Objective To compare the effect of an invitation promoting informed choice for screening with a standard invitation on attendance and motivation to engage in preventive action. Design Randomised controlled trial. Setting Four English general practices. Participants 1272 people aged 40-69 years, at risk for diabetes, identified from practice registers using a validated risk score and invited to attend for screening. Intervention Intervention was a previously validated invitation to inform the decision to attend screening, presenting diabetes as a serious potential problem, and providing details of possible costs and benefits of screening and treatment in text and pie charts. This was compared with a brief, standard invitation simply describing diabetes as a serious potential problem. Main outcome measures The primary end point was attendance for screening. The secondary outcome measures were intention to make changes to lifestyle and satisfaction with decisions made among attenders. Results The primary end point was analysed for all 1272 participants. 55.8% (353/633) of those in the informed choice group attended for screening, compared with 57.6% (368/639) in the standard invitation group (mean difference −1.8%, 95% confidence interval −7.3% to 3.6%; P=0.51). Attendance was lower among the more deprived group (most deprived third 47.5% v least deprived third 64.3%; P<0.001). Interaction between deprivation and effect of invitation type on attendance was not significant. Among attenders, intention to change behaviour was strong and unaffected by invitation type. Conclusions Providing information to support choice did not adversely affect attendance for screening for diabetes. Those from more socially deprived groups were, however, less likely to attend, regardless of the type of invitation received. Further attention to invitation content alone is unlikely to achieve equity in uptake of preventive services. Trial registration Current Controlled Trials ISRCTN 73125647.

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

BackgroundThis trial aims to evaluate the effectiveness of a group cognitive behavioural intervention to alleviate menopausal symptoms (hot flushes and night sweats) in women who have had breast cancer treatment. Hot flushes and night sweats are highly prevalent but challenging to treat in this population. Cognitive behaviour therapy has been found to reduce these symptoms in well women and results of an exploratory trial suggest that it might be effective for breast cancer patients. Two hypotheses are tested:Compared to usual care, group cognitive behavioural therapy will:1. Significantly reduce the problem rating and frequency of hot flushes and nights sweats after six weeks of treatment and at six months post-randomisation.2. Improve mood and quality of life after six weeks of treatment and at six months post-randomisation.Methods/DesignNinety-six women who have completed their main treatment for breast cancer and who have been experiencing problematic hot flushes and night sweats for over two months are recruited into the trial from oncology and breast clinics in South East London. They are randomised to either six weekly group cognitive behavioural therapy (Group CBT) sessions or to usual care. Group CBT includes information and discussion about hot flushes and night sweats in the context of breast cancer, monitoring and modifying precipitants, relaxation and paced respiration, stress management, cognitive therapy for unhelpful thoughts and beliefs, managing sleep and night sweats and maintaining changes.Prior to randomisation women attend a clinical interview, undergo 24-hour sternal skin conductance monitoring, and complete questionnaire measures of hot flushes and night sweats, mood, quality of life, hot flush beliefs and behaviours, optimism and somatic amplification. Post-treatment measures (sternal skin conductance and questionnaires) are collected six to eight weeks later and follow-up measures (questionnaires and a use of medical services measure) at six months post-randomisation.DiscussionMENOS 1 is the first randomised controlled trial of cognitive behavioural therapy for hot flushes and night sweats that measures both self-reported and physiologically indexed symptoms. The results will inform future clinical practice by developing an evidence-based, non-medical treatment, which can be delivered by trained health professionals.Trial RegistrationCurrent Controlled Trials ISRCTN13771934

The silent grief: psychosocial aspects of premature ovarian failure

Objective Premature ovarian failure in women under 40 years is uncommon, but not rare (1–3%), with up to 2.5% of adolescents affected. This study aims to investigate womens experiences of diagnosis, perception of cause, treatment, main concerns, long-term consequences and impact on self-esteem, sexual functioning and health-related quality of life. Design This was a cross-sectional study, using a single-group design, including quantitative and qualitative measures. Two hundred and twenty questionnaires were sent to women recruited from the databases of two London specialist multidisciplinary clinics and from a national premature menopause self-help website. The questionnaire included the Rosenbergs Self Esteem Questionnaire, SF 36 Health Survey (quality of life), the Sexual Personal Experiences Questionnaire and the Young Menopause Assessment questionnaire, following a pilot to assess acceptability and feasibility. Results The response rate was 62% in women aged 19–61 years. The majority of women felt that they had been offered inadequate information; 53% did not know the reason for their condition, 30% obtained a diagnosis within 6 months, and the diagnosis for 22% took up to 3 years. Fertility and bone health were main concerns, followed by emotional well-being. Libido and vaginal dryness were perceived as the main long-term effects by 79% of the women. The internet was the main source of information. The majority requested more information targeted to their age group and 49% requested psychological support, citing a negative impact on their self-esteem. Conclusions This study examined womens perceptions of premature ovarian failure, its impact and the services they received. The results can be used to inform service reconfiguration and improvement.

Psychosocial adjustment in women with premature menopause: a cross-sectional survey.

ABSTRACT Objectives Previous studies have found that women with premature menopause often report fertility problems, menopause symptoms and negative experiences of medical services. This study aims to measure the prevalence of these problems and explore whether they have negative impacts on psychosocial adjustment (symptom experience and quality of life). Methods A cross-sectional survey was mailed to women who had been diagnosed with premature menopause, recruited from hospital clinics in West London and from a patient support website (the Daisy Network). The survey measured participant characteristics, fertility problems, hot flushes and night sweats, experience of diagnosis, patient satisfaction with medical services, the Womens Health Questionnaire and the General Health Survey SF-36. Responses were described and multiple linear regressions were used to explore predictors of psychosocial functioning and quality of life. Results A total of 136 women were included in the analysis. Psychosocial functioning was relatively poor compared to typical aged menopausal women. Fertility concerns were prevalent (reported by 71% of the sample), 35% reported experiencing hot flushes and/or nights sweats, and, on average, women were neither satisfied nor unsatisfied with medical services (mean =3.00, standard deviation =0.98). Age, experiencing hot flushes and/or night sweats and patient satisfaction predicted psychosocial functioning, but only explained a small amount of the variance (3–11%). Conclusions Women with premature menopause would benefit from interventions that improve psychosocial functioning and quality of life, including improving patient experience and effective treatment of menopause symptoms. Assumptions about treatment needs could not reliably be made based on patient characteristics, suggesting that individually tailored treatments may be more effective.

A randomised controlled trial of cognitive-behavioural therapy for women with problematic menopausal hot flushes: MENOS 2 trial protocol

Objectives Hot flushes and night sweats (HF/NS) are experienced by 60–70% of menopausal women and are problematic for approximately 20–25%. Potential health risks associated with hormone-replacement therapy (HT) have led to a significant decline in HT use. There is therefore a need for safe, effective and evidence-based alternative treatments for menopausal symptoms. Previous exploratory work suggests that cognitive–behavioural therapy (CBT) is acceptable and effective for women with HF/NS during natural menopause and following breast-cancer treatment. This randomised controlled trial compares the effectiveness of Group CBT and Guided Self-Help CBT with no treatment control in reducing HF/NS Problem Rating and Frequency at post-treatment (main outcome) and at 6 months postrandomisation. Methods and analysis 120 women, with 10 or more HF/NS a week for a month, are recruited from GP surgeries and the local community of South London. They are randomised to either 4 weeks of Group CBT, 4 weeks guided Self-Help CBT or no treatment control. Participants attend a clinical interview, and complete baseline questionnaire measures of HF/NS Problem Rating and Frequency (primary outcomes), mood, quality of life, self-esteem, hot-flush beliefs and behaviours, optimism and somatic amplification, and undergo 24 h sternal skin conductance monitoring (SCC—physiological measure of HF/NS) (secondary outcomes). Post-treatment measures (SSC, questionnaires and use of medical services) are collected 6–8 weeks later and follow-up measures (questionnaires and a use of medical services measure) at 6 months postrandomisation. Ethics and dissemination Ethical registration was granted by Kings College London Research Ethics Committee (ref: PNM/08/09-42). All participants provide written informed consent. If treatment is successful, a Group CBT training manual and training sessions for health professionals, and a Self-Help CBT book will be published. Other CBT delivery options will also be examined (including Computerised Self-Help CBT and Group CBT workshops). Clinical Trial Registration Number ISRCTN57302613.

NICE guidance on menopause: cognitive behavioural therapy is an effective non-hormonal intervention for managing vasomotor symptoms

The full document of the first National Institute for Health and Care Excellence (NICE) guideline on diagnosis and management of menopause1 recommends (page 18) that GPs should: “Give information to menopausal women and their family members or carers (as appropriate) about the following types of treatment for menopausal symptoms: