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

A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13771934
Enrollment
96
Registered
2009-03-17
Start date
2009-03-01
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer and menopause Cancer Malignant neoplasm of the breast

Interventions

Cognitive behavioural therapy encompassing stress management, cognitive restructuring and sleep hygiene for treatment of hot flushes and night sweats. Group CBT: The t

Sponsors

King's College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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).

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026