A trial of a non-medical treatment for menopausal symptoms in women with breast cancer

ISRCTN ISRCTN13771934
DOI https://doi.org/10.1186/ISRCTN13771934
Protocol serial number C8303/A6130
Sponsor King's College London (UK)
Funder Cancer Research UK (CRUK) (UK) (ref: 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

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-at-a-way-of-reducing-menopausal-symptoms-after-treatment-for-breast-cancer

Contact information

Prof Myra Hunter
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

Primary study designInterventional
Study designMulticentre randomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment
Study acronymMENOS1
Study objectivesPrimary 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) studiedBreast cancer and menopause
InterventionCognitive 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 typeOther
Primary outcome measure(s)

Problem rating of hot flushes and night sweats, measured at 12 weeks post-randomisation

Key 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).

Completion date31/12/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target sample size at registration96
Key inclusion criteria1. 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 criteria1. 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 enrolment01/03/2009
Date of final enrolment31/12/2011

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Unit of Psychology
London
SE1 9RT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing planNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Plain English results 24/03/2022 No Yes

Editorial Notes

24/03/2022: Plain English results added.

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