MENOS 4
Research type
Research Study
Full title
A multicentre randomised controlled trial of a breast care nurse delivered cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flushes in women with breast cancer
IRAS ID
200315
Contact name
Deborah Fenlon
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
1 years, 4 months, 30 days
Research summary
Hot flushes and night sweats (HFNS) are experienced by up to 70% women after treatment for breast cancer and can have negative effects on daily life and sleep quality. In some cases, this can affect employment, relationships and quality of life. Cognitive behavioural therapy (CBT) delivered in group-format can help reduce the effects of HFNS in both women with and without breast cancer. It can also offer benefits such as improvements in mood and quality of life.
This study will look at whether group CBT delivered by NHS breast care nurses can effectively reduce the impact of hot flushes in women who have completed treatment for breast cancer.
Women aged 16 years and over, who have completed treatment for primary breast cancer and experience persistent, problematic hot flushes will be eligible to participate. 120-160 women will be recruited from UK sites, half (60-80 women) of whom will be invited to attend group CBT for six weeks. The other half (60-80 women) will continue to receive standard NHS treatment during this time.
All participants will be asked to complete a range of questionnaires assessing the impact of hot flushes at baseline, nine and 26 weeks post-randomisation. We will then compare results from both groups to establish whether group CBT is more effective than standard NHS treatment at reducing the impact of hot flushes. The study will last 26 weeks in total.
This research is funded by Breast Cancer Now, a UK-based breast cancer charity.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0364
Date of REC Opinion
17 Aug 2016
REC opinion
Further Information Favourable Opinion