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A trial of a non-medical treatment for menopausal symptoms in women with breast cancer
ISRCTN ISRCTN13771934
DOI 10.1186/ISRCTN13771934
ClinicalTrials.gov identifier
EudraCT number
Public title A trial of a non-medical treatment for menopausal symptoms in women with breast cancer
Scientific title A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment
Acronym MENOS1
Serial number at source C8303/A6130
Study hypothesis Primary objective:
To determine the efficacy of group cognitive behavioural therapy (CBT) compared to usual care in reducing the problem rating of menopausal symptoms (hot flushes and night sweats), 12 weeks post-randomisation, in women who have had treatment for breast cancer.

Secondary objectives:
1. To investigate the efficacy of group CBT compared to usual care in reducing the problem rating of menopausal symptoms of hot flushes and night sweats, up to 6 months (26 weeks) post-randomisation, in women who have had treatment for breast cancer
2. To investigate the efficacy of group CBT compared to usual care in reducing the frequency (subjective and objective) of hot flushes and night sweats, 12 weeks post-randomisation, in women who have had treatment for breast cancer
3. To investigate the efficacy of group CBT compared to usual care in reducing the frequency (subjective) of hot flushes and night sweats, 6 months (26 weeks) post-randomisation, in women who have had treatment for breast cancer
Lay summary http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-at-a-way-of-reducing-menopausal-symptoms-after-treatment-for-breast-cancer
Ethics approval St Thomas' Hospital Research Ethics Committee (South London REC Office 3) gave approval on the 23rd July 2008 (ref: 08/H0802/106)
Study design Multicentre randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Breast cancer and menopause
Participants - inclusion criteria 1. Aged 18 years and older and have had early stage breast cancer
2. Have completed radiotherapy and chemotherapy
3. No evidence of distant metastatic disease
4. May have had ductal carcinoma in situ (DCIS)
5. English speaking
6. Have had problematic hot flushes (HF)/night sweats (NS) for at least 2 months
7. Having completed active treatment and being in remission
8. Prior medical treatment for HF/NS will be recorded. If women have derived partial benefit and are stable on a treatment, they can be included if they have been on this treatment for 2 months or longer.
Participants - exclusion criteria 1. Depression or general cancer concerns are the main problem that the woman is seeking help for, not HF/NS
2. Unable to commit time to attend the sessions
Anticipated start date 01/03/2009
Anticipated end date 31/12/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 96
Interventions Cognitive behavioural therapy encompassing stress management, cognitive restructuring and sleep hygiene for treatment of hot flushes and night sweats.

Group CBT:
The treatment comprises 6 weekly sessions lasting 1.5 hours. Groups will comprise 8 - 10 women and a CBT therapist will run all the sessions. A proportion of sessions will be taped and evaluated by an independent assessor to ensure that Group CBT strictly follows the manual. The approach is psycho-educational with individual treatment goals and an active focus upon cognitive and behavioural changes. The treatment targets cognitive and behavioural components:
1. Information and discussion about HF/NS and menopause
2. Monitoring and modifying precipitants, e.g. spicy food, alcohol
3. Relaxation and paced respiration, to lower levels of stress and apply at onset of HF/NS
4. Behavioural strategies to reduce stress and deal with HF/NS
5. Cognitive therapy for unhelpful thoughts and beliefs about HF/NS and menopause
6. Managing sleep and NS, drawing upon CBT for insomnia
7. Managing menopausal symptoms and maintaining changes the context of breast cancer

Usual care:
The control arm will receive standard care - they will have access to their oncologist and clinical nurse specialist, as well as cancer information and support services, and be offered a form of CBT off-trial at the end of the trial.

Duration per patient: 3 months assessment and treatment, and 6 months follow-up post-randomisation = approximately 9 months.
Primary outcome measure(s) Problem rating of hot flushes and night sweats, measured at 12 weeks post-randomisation
Secondary outcome measure(s) 1. Frequency of hot flushes and night sweats (physiologically measured and self reported)
2. Mood, sleep and quality of life
3. Treatment cost-effectiveness

Measured at 12 weeks post-randomisation (all measures) and 6 months post-randomisation (except physiological measure of frequency of hot flushes and night sweats).
Sources of funding Cancer Research UK (CRUK) (UK) (ref: C8303/A6130)
Trial website
Publications 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21281461
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22340966
Contact name Prof  Myra  Hunter
  Address Unit of Psychology
5th Floor Thomas Guy House
Guy's Campus
King's College London
London Bridge
  City/town London
  Zip/Postcode SE1 9RT
  Country United Kingdom
  Email myra.hunter@kcl.ac.uk
Sponsor King's College London (UK)
  Address Strand
  City/town London
  Zip/Postcode WC2R 2LS
  Country United Kingdom
  Sponsor website: http://www.kcl.ac.uk/
Date applied 23/02/2009
Last edited 25/04/2012
Date ISRCTN assigned 17/03/2009
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