A trial of a non-medical treatment for menopausal symptoms in women with breast cancer
ISRCTN | ISRCTN13771934 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN13771934 |
Secondary identifying numbers | C8303/A6130 |
- Submission date
- 23/02/2009
- Registration date
- 17/03/2009
- Last edited
- 24/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Myra Hunter
Scientific
Scientific
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 |
Study information
Study design | Multicentre randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment |
Study acronym | MENOS1 |
Study objectives | 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(s) | St Thomas' Hospital Research Ethics Committee (South London REC Office 3) gave approval on the 23rd July 2008 (ref: 08/H0802/106) |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 01/03/2009 |
Completion date | 31/12/2011 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | 96 |
Key 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. |
Key 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 |
Date of first enrolment | 01/03/2009 |
Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Unit of Psychology
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Strand
London
WC2R 2LS
England
United Kingdom
Website | http://www.kcl.ac.uk/ |
---|---|
https://ror.org/0220mzb33 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: C8303/A6130)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 31/01/2011 | Yes | No | |
Results article | results | 01/03/2012 | Yes | No | |
Plain English results | 24/03/2022 | No | Yes |
Editorial Notes
24/03/2022: Plain English results added.