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The University of Southampton
Southampton Clinical Trials Unit

MENOS 4

Trial Name

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. 

Description

Hot flushes (also known as hot flashes) and night sweats have been identified as a major physical symptom experienced by women with breast cancer by the breast cancer research gap analysis [1]. This analysis highlighted the need for appropriate interventions that enable women to manage hot flushes and night sweats. It also highlighted that there is inadequate translation of research findings into clinical practice and, specifically, that there is a need to consider how current therapies, such as cognitive behavioural therapy (CBT) can be better integrated to make it more accessible to patients.

CBT offers a promising intervention. The use of therapy to teach ways of managing symptoms has been shown to be a popular treatment option among women with breast cancer experiencing symptoms of menopause [2]. Its efficacy has been proven in this group through several previous trials, demonstrating reduction in number of hot flushes [3] and perceived burden associated with hot flushes [4]. Additionally, CBT delivered to women with breast cancer in a group setting was shown to significantly reduce the Hot Flush and Night Sweats problem rating score in the MENOS 1 trial [5].

MENOS 4 will assess the effectiveness and cost-effectiveness, compared to usual care, of group CBT when it is delivered by breast care nurses, which would widen access to the intervention. Based on previous research, we expect that group CBT will lead to a meaningful reduction in the impact of hot flushes and night sweats, as well as improving mood and physical and social functioning. The intervention will equip women to develop a more accepting viewpoint of their symptoms and gain increased sense of control and confidence in dealing with hot flushes and night sweats. Further benefits may be gained by applying CBT strategies to other life stresses, resulting in improved quality of life at home and at work.

Objectives

Primary objective:

Secondary Objectives:

Design

A multi-centre phase III individually randomised controlled trial of a group CBT intervention versus treatment as usual. 

Status

Complete

Population

Sample size of 120-160 patients meeting the following criteria:

 

Publication

MENOS4 trial: a multicentre randomised controlled trial (RCT) of a breast care nurse delivered cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flushes in women with breast cancer: Study Protocol 

Contact Details

All Trial enquiries should be addressed to ctu@soton.ac.uk

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