A trial of a non-medical treatment for menopausal symptoms in women with breast cancer
- Conditions
- Breast cancer and menopauseCancerMalignant neoplasm of the breast
- Registration Number
- ISRCTN13771934
- Lead Sponsor
- King's College London (UK)
- Brief Summary
2011 Results article in http://www.ncbi.nlm.nih.gov/pubmed/21281461 results 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22340966 results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 96
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Problem rating of hot flushes and night sweats, measured at 12 weeks post-randomisation
- Secondary Outcome Measures
Name Time Method <br> 1. Frequency of hot flushes and night sweats (physiologically measured and self reported)<br> 2. Mood, sleep and quality of life<br> 3. Treatment cost-effectiveness<br><br> Measured at 12 weeks post-randomisation (all measures) and 6 months post-randomisation (except physiological measure of frequency of hot flushes and night sweats).<br>