Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Prof Myra Hunter
ORCID ID
Contact details
Unit of Psychology
5th Floor Thomas Guy House
Guy's Campus
King's College London
London Bridge
London
SE1 9RT
United Kingdom
myra.hunter@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
C8303/A6130
Study information
Scientific title
A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment
Acronym
MENOS1
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer and menopause
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Problem rating of hot flushes and night sweats, measured at 12 weeks post-randomisation
Secondary outcome measures
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).
Overall trial start date
01/03/2009
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
96
Participant 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
Recruitment start date
01/03/2009
Recruitment end date
31/12/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Unit of Psychology
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Strand
London
WC2R 2LS
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C8303/A6130)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21281461
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22340966
Publication citations
-
Results
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, doi: 10.1186/1471-2407-11-44.
-
Results
Mann E, Smith MJ, Hellier J, Balabanovic JA, Hamed H, Grunfeld EA, Hunter MS, Cognitive behavioural treatment for women who have menopausal symptoms after breast cancer treatment (MENOS 1): a randomised controlled trial., Lancet Oncol., 2012, 13, 3, 309-318, doi: 10.1016/S1470-2045(11)70364-3.