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The University of Southampton
Southampton Clinical Trials Unit

MENOS 4

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.

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:

  • Can group CBT delivered by breast care nurses reduce the impact of hot flushes and night sweats in women with breast cancer at 26 weeks post-randomisation?

Secondary Objectives:

  • Reduction of the impact of hot flushes and night sweats at 9 weeks post randomisation
  • The level of fidelity of the CBT when delivered by breast care nurses
  • The effect of the intervention on other symptoms, such as anxiety and depression
  • Resource usage
  • Quality of Life (QoL) measured by EQ-5D-5L
  • Estimate of the cost-effectiveness of the intervention
  • The effect on women’s hot flush beliefs and behaviours
  • Breast care nurses’ experiences of introducing this new service
  • Key stakeholders experiences of the process of introducing this new service and perceived impact of the intervention on the wider service
  • Participants’ acceptability of the intervention

Trial Design

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

Trial Status

In follow-up

Population

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

  • Women with primary breast cancer or DCIS
  • Women who have completed primary treatment: surgery and/or radiotherapy and / or chemotherapy (may still be receiving adjuvant endocrine therapy or Herceptin)
  • Aged 16 years+
  • Experiencing seven or more HFNS/week with an overall rating of 4/10 or above on the HF problem rating scale
  • Ability to attend group sessions
  • Signed informed consent

Trial Team:

Senior Trial Manager:

Jacqui Nuttall (023 8120 3866)

Contact information

Email: menos4@soton.ac.uk

Fax: 0844 7740 621

 

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