King's College London - MENOS - Menopause research and clinical trials

Research group

MENOS - Menopause research and clinical trials

MENOS Research Group

Professor Myra Hunter

Dr Claire Hardy

RECENTLY COMPLETED AND CURRENT STUDIES

MENOS 1- RCT of Group CBT for women with problematic hot flushes related to breast cancer treatment

MENOS 2-RCT of Group and guided Self Help CBT for women with problematic hot flushes during the menopause transition

MENOS 3- evaluation of telephone supported Self-Help CBT for women with problematic hot flushes

MENOS 4- RCT testing the feasibility of breast cancer nurse delivered Group CBT for women with problematic hot flushes related to breast cancer treatment

MENOPAUSE@WORK – evaluation of a brief CBT intervention for women with problematic hot flushes at work, and developing brief interventions to increase knowledge and awareness of the menopause in the workplace.

MANCAN – RCT of a brief cognitive behavioural intervention for hot flushes related to prostate cancer treatment.

MENOS - Menopause research and clinical trials

The menopause occurs on average between the ages of 50 and 51 and literally refers to a woman’s last menstrual period. The menopause transition takes place within a gradual process of physiological change, occurring concurrently with age and developmental changes, and within varied psychosocial and cultural contexts.

Anthropological and cross-cultural studies have challenged the concept of the menopause as a universal phenomenon with wide variations in the symptom perception and reporting in women from different ethnic origins living in different countries. Cultural explanations of these differences include lifestyle (diet, exercise, social factors, as well as reproductive patterns) which can affect biological processes, population differences, as well as beliefs and attitudes to the menopause and the social status of mid-aged and older women.

Psychological research on menopause includes investigation of the meanings of menopause, appraisals and attributions of symptoms to menopause, as well as cognitive, affective and behavioural reactions to the menopause. Hot flushes and night sweats are the main bodily changes that are attributable to the menopause. Current research is focusing on physiological and subjective assessment of hot flushes as well as the development of cognitive interventions for hot flushes or vasomotor symptoms, since many women are now seeking non-hormonal approaches to treatment.

Cognitive behavioural intervention trials for the management of menopausal symptoms

The aims of these studies are to evaluate the effectiveness of cognitive behavioural interventions (CBT) in alleviating menopausal symptoms (hot flushes and night sweats). Cognitive behavioural interventions, including relaxation, have been found to reduce menopausal symptoms in well women (Hunter & Liao, 1996, Hunter, 2003), and the results of an 18 month exploratory trial of group CBT funded by Cancer Research UK suggest that such treatments can also be effective with women who experience these symptoms following breast cancer treatments (Hunter et al, 2009).

We completed two randomised controlled trials of cognitive behavioural interventions for menopausal symptoms: MENOS 1 & MENOS 2 (Ayers et al 2012 and Mann et al 2012) which demonstrate the effectiveness of CBT for reducing the impact of hot flushes and night sweats

MENOS 1

Efficacy of a cognitive behavioural intervention to treat menopausal symptoms following breast cancer treatment (MENOS 1): a randomised controlled trial. Lancet Oncology 13(3), 309–318 (2012). Funded by Cancer Research UK

Women with breast cancer may experience menopausal symptoms as a side effect of treatment, which can be more severe with fewer treatment options. MENOS 1 compared Group CBT with Usual care for women with problematic hot flushes and night sweats (HFNS) following breast cancer treatments. Women who were experiencing problematic HFNS (minimum 10 problematic HF/NS a week) were randomised to receive either usual care (n=49) or Group CBT plus usual care (n=47). Assessments were conducted at baseline, 9 and 26 weeks post-randomisation. Group CBT significantly reduced HF/NS problem rating at 9 weeks post-randomisation compared to usual care (p<0.001) and improvements were maintained at 26 weeks (p<0.001). At 26 weeks, 78% of women in the CBT arm had a clinically significant reduction in HF/NS problem rating (change score greater than 2 points from baseline) compared to 33% (95% CI: 20 to 48%) in the usual care arm. CBT had less impact on HF/NS frequency; although those having Group CBT reported fewer night sweats at 26 weeks. Similarly, neither group showed significant changes in physiologically (sternal skin conductance) measured HF/NS. However, there were significant improvements in mood, sleep, and quality of life for Group CBT compared to usual care.

MENOS 2

Ayers B, Smith M, Hellier J, Mann E and Hunter MS. Effectiveness of group and self-help cognitive behaviour therapy to reduce problematic menopausal hot flushes and night sweats (MENOS 2): a randomized controlled trial. Menopause 19,7:749-759 (2012). Funded by NIHR BRC

Between 50 and 70% of women experience hot flushes and night sweats (HF/NS) during the menopause transition and approximately 20% have troublesome symptoms for which they seek help. Many women prefer to use non-medical treatments for these symptoms. There is evidence from previous work that individual and group CBT may help women to manage and reduce their symptoms, and may have additional benefits to mood and health-related quality of life. In MENOS2 140 women having problematic HF/NS (minimum 10 problematic HF/NS a week) were randomised to Group CBT, Self-Help CBT or no treatment control (NTC). Group CBT and Self-Help CBT both significantly reduced HF/NS problem rating at 6 weeks: Group CBT versus no NTC (p<0.001), Self-Help CBT vs. NTC (p<0.001). Approximately 65 and 73% of Group and Self-Help women, respectively, reported a clinically significant improvement of two-points or more on the HF/NS problem rating scale at 6 weeks and changes were maintained at 26 weeks. Group and Self-Help CBT significantly reduced night sweat frequency at 26 weeks. Finally, there were improvements in mood and quality of life at 6 weeks and improved emotional and physical functioning for Group CBT at 26 weeks.

MENOS 3

Results from MENOS 1 and MENOS 2 trials show that cognitive behavioral treatments (CBT) delivered in Group and Self-Help formats can be effective and safe treatment options for women experiencing problematic vasomotor symptoms (i.e. hot flushes and night sweats).

MENOS 3 aims to make CBT interventions more widely accessible to women who are unable to attend groups or other meetings with us, e.g. women who live too far away/outside London or they are unable to attend meetings due to family, work or other commitments. In MENOS 3, women are offered a Self-Help CBT booklet which includes weekly exercises, homework tasks and daily diaries that they complete over a four-week period. We have used this Self-Help intervention in the MENOS2 trial with two guided sessions and we found that this intervention significantly improved women’s experiences of their symptoms (Ayers, Smith, Hellier, Mann & Hunter, 2012). In a recent study using a self-help booklet and brief telephone support was a beneficial way to deliver the CBT resulting in improvement in the experience of hot flushes (Stefanopoulou & Hunter, Maturitas, 2014). In Sept 2013 we published the 4 week self-help book for women:

Managing Hot Flushes and Night Sweats: a cognitive behavioural self-help guide to the menopause. Myra Hunter & Melanie Smith published by Routledge https://www.routledge.com/Managing-Hot-Flushes-and-Night-Sweats-A-cognitive-behavioural-self-help/Hunter-Smith/p/book/9780415625159

In January 2015 we published a manual for health professionals to use to run groups for women with menopausal symptoms in clinical settings.

Managing Hot Flushes with Group CBT: an evidence based manual for health professionals, Hunter & Smith, published by Routledge 2015. https://www.routledge.com/Managing-Hot-Flushes-with-Group-Cognitive-Behaviour-Therapy-An-evidence-based/Hunter-Smith/p/book/9781138026155

MENOS 4

Menos 4 is due to start early in 2016 and is a collaboration between researchers at Southampton University and King’s College London (Fenlon D, Hunter MS and colleagues). We aim to include breast cancer centres across the UK and offer training in Group

MENOPAUSE@WORK

Menopause at work: development of brief interventions to improve the quality of life of working menopausal women, funded by Wellbeing of Women 2015-2018

There are over 3.5 million women in employment aged between 50 and 65 in the UK (Office National Statistics, 2013) and, as menopause occurs on average between the ages of 50–51 and can lasts for up to ten years (Hunter et al, 2012), at any one time, a significant proportion of mid-aged and older women workers will be experiencing menopausal symptoms. Yet there is a general lack of awareness and communication about menopause in work settings. Hot flushes are often seen as embarrassing and women report being concerned about the reactions of others to their symptoms (Smith et al, 2011). Although an under-researched area, there is evidence that some women find that menopause has negative effects at work and that certain work situations and physical working environments increase the intensity of menopausal symptoms (Griffiths et al, 2013).

Working with Prof Amanda Griffiths from Nottingham University, we aim to:

(i) To test the feasibility of implementing a self-help intervention (on-line or booklet) based on cognitive behaviour therapy (Hunter & Smith 2014) for menopausal women to use to manage menopausal symptoms at work.

(ii) To develop a brief intervention (workshop, online or booklet) to increase awareness of menopause amongst employers to enable them to offer women information and practical advice.

(iii) To evaluate both interventions using quantitative measures and qualitative interviews to assess feasibility, outcomes and acceptability.

For further information please contact Dr Claire Hardy claire.hardy@kcl.ac.uk

Additional Current Studies

IMS-CAT: International menopause study of climate, culture and temperature on experience of menopause – first phase in 5 South American Centres (with Gupta, Sturdee and Palacios); second phase in urban regions in the Indian subcontinent and the third phase in the United Arab Emirates. We are currently working with colleagues in Thailand to assess the impact of altitude, seasons and temperature on hot flush reporting.
A five-year collaborative study EVA with Professor Aaronson and colleagues in Amsterdam funded by the Dutch Cancer Society (06-11), comparing Group CBT with exercise and a no treatment control condition for vasomotor symptoms (hot flushes and night sweats) in younger breast cancer patients. We found that CBT was more effective than exercise in this pilot trial. We developed a computerised version of the CBT (cCBT) and we are starting an RCT ting comparing cCBT with usual care for women with menopausal symptoms following breast cancer treatments (Aaronson, Cuipers, Hunter 2016-2018).
MMS (Managing menopausal Symptoms): A study of beliefs and help-seeking behaviour amongst mid-aged women with vasomotor symptoms, including beliefs about medications between women using complementary therapies and medical treatments (with Menon, Jacobs, Fraser and Gentry-Maharaj, Institute of Women’s Heath UCL).
Neurokinin B Administration Induces Hot Flushes in Women: Neurokinin B (NKB) is a hypothalamic neuropeptide binding preferentially to the neurokinin 3 receptor, but the effects of NKB administration on hot flushes have not been investigated in humans. We inputted to a pilot, study led by Prof Dhillo at Imperial College, the results of which suggested that NKB administration might cause hot flushes in women (Scientific Reports 02/2015; 5:8466. DOI:10.1038/srep08466 • 5.08). A larger RCT is planned to start later in 2015 funded by the MRC.

If you would like to find out more or you are interested in taking part in our studies please contact:

Prof Myra Hunter Email: myra.hunter@kcl.ac.uk

Dr Claire Hardy Email: claire.hardy@kcl.ac.uk

Publications

Hunter M.S. & Rendall M. Bio-psycho-socio-cultural perspectives on menopause. Best Practice and Research Clinical Obstetrics & Gynaecology, 2007 21 (2) 261-274.

Menon U, Burnell M, SharmaA, Gentry-MaharajA. FraserL, ParmarM,.Hunter MS, JacobsIJ. Decline in women using hormone replacement therapy at recruitment to a large screening trial in the UK. Menopause: J of the North American Menopause Society, 2007 14 462-467.

Hunter M.S. The Women’s Health Questionnaire (WHQ): the development, standardisation and application of a measure of mid-aged women’s emotional and physical health. Qual. Life Res. 2000, 9 733-738.

Hunter MS, Liao KLM. Evaluation of a four session cognitive behavioural intervention for menopausal hot flushes. Brit J Clin Psychol, 1996 1, 113-125.

Hunter M.S. and Liao K.L.M. A psychological analysis of menopausal hot flushes. Brit. J. Clin. Psychol. 1995 34 589-599.

Hunter M.S. The Women's Health Questionnaire: a measure of mid-aged women’s perceptions of their emotional and physical health. Psychol. Health 1992 7 45-54

Hunter MS, Coventry S, Hamed H, Fentiman I & Grunfeld AE. (2008) Evaluation of a cognitive behavioural intervention for women suffering from menopausal symptoms following breast cancer treatment. Psycho-oncology 18, 560-563.

Rendall MJ, Simmons LM & Hunter MS (2008) The Hot Flush beliefs Scale: a tool for assessing thoughts and beliefs associated with experience of menopausal hot flushes and night sweats. Maturitas, 60, 158-169.

Hunter M.S., Gupta P., Papitsch-Clarke A., Bhugra D., Sturdee D. (2008) Culture, country of residence and subjective well-being: a comparison of South Asian mid-aged women living in the UK, UK Caucasian women and women living in Delhi, India. International Journal of Medicine and Culture 1, 1, 44-57.

Hunter MS, Coventry S, Mendes N, Grunfeld AE. (2009) Menopausal symptoms following breast cancer treatment: a qualitative investigation of cognitive and behavioural responses. Maturitas 63, 336-340.

Hunter MS, Gupta P, Papitsch-Clarke A, Sturdee D (2009) Mid-aged Health in Women from the Indian Subcontinent (MAHWIS): a quantitative and qualitative study of experience of menopause in UK Asian women, compared to UK Caucasian and women living in Delhi. Climacteric 12,1 26-37.

Ayers B, Fisher M, Hunter MS. A systematic review of the role of attitudes to the menopause upon experience of menopause. Maturitas 2010, 65; 28–36

Hunter MS, Haqqani JR. An investigation of the discordance between subjective perception and physiological measures of menopausal hot flushes. Climacteric 2011, 13, 6: 146–151.

Hunter MS, Mann E. A cognitive model of menopausal hot flushes. J Psychosomatic Research 2010 69, 5, 491-501.

Hunter MS. Menopausal symptoms in cancer patients. MIMS Women’s Health 2010.

Mann E, Hunter MS. Concordance between self-reported and sternal skin conductance measures of hot flushes in symptomatic menopausal women: a systematic review. Menopause: J American Menopause Society 2011 18, 6, 709-722.

Smith MJ, Mann E, Mirza A, Hunter MS. Men and women’s perceptions of hot flushes within social situations: are menopausal women’s negative beliefs valid? Maturitas 2011 69, 57-62.

Singer D, Mann E, Hunter MS, Pitkin J, Panay N. The Silent Grief: psychosocial aspects of premature ovarian failure. Climacteric, 2011, 14, 4, 428-437.

Ayers B, Forshaw M, Hunter MS. Menopause from culture to body experience. The Psychologist May 2011, 24, 5 348-352.

Mann E, Smith M, Hellier J, Hunter MS. A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment (MENOS 1): Trial protocol. BMC Cancer 2011,11: 44.

Archer DF, Sturdee DW, Baber R, de Villiers TJ, Pines A, Freedman RR, Gompel A, Hickey M, Hunter MS, Lobo RA, Lumsden MA, MacLennan AH, Maki P, Palacios S, Shah D, Villaseca P, and Warren M. Menopausal hot flushes and night sweats: where are we now? Climacteric 2011, 14, 5, 515-528.

Ayers B, Mann E, Hunter MS. A randomised controlled trial of a group and self help cognitive behavioural interventions for women who have menopausal symptoms MENOS2. BMJ Open 2011;1:e000047. doi:10.1136/bmjopen-2010-000047.

Hunter MS, Ayers B, Smith M. The Hot Flush Behavior Scale: a measure of behavioral reactions to menopausal hot flushes and night sweats. Menopause: The Journal of the North American Menopause Society. 2011,18, 11, 1178-83.

Hunter MS, Gentry-Maharaj A, Ryan A, Burnell M, Lanceley A, Fraser L, Jacobs, Menon U. Prevalence, frequency and problem rating of hot flushes persist in older postmenopausal women: impact of age, BMI, hysterectomy, lifestyle and mood in a cross sectional cohort study of 10,418 British women aged 54-65. British J Obstetrics & Gynaecology 2012 119: 40–50.

Mann E, Smith MJ, Hellier J, Hamed H, Balabanovic, J., Hamed, H., Grunfeld B, Hunter MS. Efficacy of a cognitive behavioural intervention to treat menopausal symptoms following breast cancer treatment (MENOS 1): a randomised controlled trial. Lancet Oncology 2012;13(3):309–318.

Mann E, Singer D, Pitkin J, Panay N, Hunter MS. Psychosocial adjustment in women with premature menopause: a cross-sectional survey. Climacteric Oct 2012, 15, 5: 481–489.

Hammam RAM, Abbas RA, Hunter MS. Menopause and Work – A Survey of Middle-Aged Female Teaching Staff in an Egyptian Governmental Faculty of Medicine. Maturitas 2012, 71;(3)294-300.

Balabanovic J, Ayers B, Hunter MS. An exploration of women’s experiences of Group Cognitive Behaviour Therapy to treat breast cancer treatment-related hot flushes and night sweats: An interpretative phenomenological analysis. Maturitas 2012 72(3), 236–242.

Ayers B, Hunter MS. Health-related quality of life of women with menopausal hot flushes and night sweats. Climacteric 2013 16;235-239.

Hunter M.S., Gupta P., Chedraui P., Blümel J.E., Tserotas K., Aguirre W., Palacios S., Sturdee D. The International Menopause Study of climate, altitude, temperature (IMS-CAT) and vasomotor symptoms. Climacteric 2013,16; 8-16.

Hunter M.S. Cognitive behavioural interventions for the treatment of menopausal symptoms. Expert Review Obstetrics Gynaecology, 2012, 7,4, 321-326.

Yousaf O., Stefanopoulou E., Grunfeld E.A., Hunter M.S. A randomised controlled trial of a cognitive behavioural intervention for men who have hot flushes following prostate cancer treatment (MANCAN): Trial protocol. BMC Cancer 2012, 12:230. DOI: 10.1186/1471-2407-12-230.

Duijts SFA, van Beurden M, Oldenburg HSA, Hunter MS, Kieffer JM, Stuiver MM, Gerritsma MA, Menke-Pluymers MBE, Plaisier PW, Rijna H, Lopes Cardozo AMF, Timmers GJ, van der Meij S, van der Veen H, Bijker H, de Widt-Levert LM, Geenen MM, Heuff G, van Dulken EJ, Boven E, Aaronson NK. Efficacy of cognitive behavioral therapy and physical exercise in alleviating treatment-induced menopausal symptoms in patients with breast cancer: results of a randomized controlled multicenter trial. J Clin Oncology 2012: 30 [33]: 4124-4133.

Balabanovic J, Ayers B and Hunter M.S.Cognitive Behaviour Therapy for Menopausal Hot Flushes and Night Sweats: A Qualitative Analysis of Women’s Experiences of Group and Self-Help CBT. Behavioural and Cognitive Psychotherapy, 2013 41(4):441-57.

Hunter M.S. and Chilcot J. Testing a cognitive model of menopausal hot flushes and night sweats. J Psychosomatic Research 2013 74(4):307-12.

Abbas, R.A., Hammam, R.A.M., El-Gohary S.S., Sabik L.M.E., Hunter M.S. Screening for common mental disorders and substance abuse among temporary hired cleaners in Egyptian governmental hospitals, Zagazig City, Sharqia Governorate. International J Occupational and Environmental Medicine (IJOEM) 4 1: 2013 Vol 4, No 1 13-26.

Eccles, S. A., Aboagye, E. O., Ali, S., Anderson, A. S., Armes, J., Berditchevski, F, et al (2013). Critical research gaps and translational priorities for the successful prevention and treatment of breast cancer. Breast Cancer Research, 15(5), R92.

Eziefula C, Grunfeld EA, Hunter MS. "You know I’ve joined your club… I’m the hot flush boy”: a qualitative exploration of hot flushes in men undergoing androgen deprivation therapy for prostate cancer Psychooncology 2013 22 912) 2823-2830.

Stefanopoulou E. Hunter M.S. Does pattern recognition software using the Bahr monitor improve sensitivity, specificity and concordance of ambulatory skin conductance monitoring of hot flushes? Menopause 2013, 20 (11) 1133-1138.

Chilcot J, Norton S, Hunter MS. Cognitive behaviour therapy for menopausal symptoms following breast cancer treatment: who benefits and how does it work? Maturitas doi: 10.1097/GME.0000000000000095 (on line).

Hunter MS and Smith M. Managing hot flushes and night sweats: a cognitive behavioural approach to menopause. Routledge (2013). www.routledgementalhealth.com/books/details/9780415625159/

Daley AJ, Stokes-Lampard H, Thomas A, Rees M, Coleman S, Roalfe A, Hunter MS, MacArthur C. Aerobic exercise as a treatment for vasomotor menopausal symptoms: Randomised controlled trial protocol. Maturitas 76, 4, 350-356.

Norton S, Chilcot J, Hunter MS. Cognitive behaviour therapy for menopausal symptoms (hot flushes and night sweats): moderators and mediators of treatment effects. Menopause 2014 on line. doi: 10.1097/GME.0000000000000095

Evgenia Stefanopoulou, Duru Shah, Rashmi Shah, Pratima Gupta, David Sturdee, Myra S. Hunter An International Menopause Society study of Climate, Altitude, Temperature (IMS-CAT) and vasomotor symptoms in urban Indian regions. Climacteric 2013, 16, 1-8.

Stefanopoulou E and Hunter MS. (2013) Telephone-guided Self Help Cognitive behaviour therapy for menopausal symptoms. Maturitas 2014, 77 (1) 73-77.

Stefanopoulou E, Yousaf O, Grunfeld EA, and Hunter MS. A randomised controlled trial of a brief cognitive behavioural intervention for men who have hot flushes following prostate cancer treatment (MANCAN). Psycho-oncology 2015 DOI: 10.1002/pon.3794 (open access).

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MENOS - Menopause research and clinical trials

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