Skip to main content
main-content

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

BMC Women's Health 1/2018

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

Zeitschrift:
BMC Women's Health > Ausgabe 1/2018
Autoren:
Deborah Fenlon, Jacqueline Nuttall, Carl May, James Raftery, Jo Fields, Emma Kirkpatrick, Julia Abab, Mary Ellis, Taylor Rose, Priya Khambhaita, Angeliki Galanopoulou, Tom Maishman, Jo Haviland, Gareth Griffiths, Lesley Turner, Myra Hunter
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s12905-018-0550-z) contains supplementary material, which is available to authorized users.

Abstract

Background

Women who have been treated for breast cancer may identify vasomotor symptoms, such as hot flushes and night sweats (HFNS), as a serious problem. HFNS are unpleasant to experience and can have a significant impact on daily life, potentially leading to reduced adherence to life saving adjuvant hormonal therapy. It is known that Cognitive Behavioural Therapy (CBT) is effective for the alleviation of hot flushes in both well women and women who have had breast cancer. Most women with breast cancer will see a breast care nurse and there is evidence that nurses can be trained to deliver psychological treatments to a satisfactory level, whilst also maintaining treatment fidelity. The research team will assess whether breast care nurses can effectively deliver a CBT intervention to alleviate hot flushes in women with breast cancer.

Methods

This study is a multi-centre phase III individually randomised controlled trial of group CBT versus usual care to reduce the impact of hot flushes in women with breast cancer. 120–160 women with primary breast cancer experiencing seven or more problematic HFNS a week will be randomised to receive either treatment as usual (TAU) or participation in the group CBT intervention plus TAU (CBT Group).
A process evaluation using May’s Normalisation Process Theory will be conducted, as well as practical and organisational issues relating to the implementation of the intervention. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost effectiveness of the intervention will also be assessed.

Discussion

There is a need for studies that enable effective interventions to be implemented in practice. There is good evidence that CBT is helpful for women with breast cancer who experience HFNS, yet it is not widely available. It is not yet known whether the intervention can be effectively delivered by breast care nurses or implemented in practice. This study will provide information on both whether the intervention can effectively help women with hot flushes and whether and how it can be translated into routine clinical practice.

Trial registration

ISRCTN 12824632. Registered 25–01-2017.
Zusatzmaterial
Literatur
Über diesen Artikel

Weitere Artikel der Ausgabe 1/2018

BMC Women's Health 1/2018 Zur Ausgabe

Neu im Fachgebiet Gynäkologie und Geburtshilfe

Mail Icon II Newsletter

Bestellen Sie unseren kostenlosen Newsletter Update Gynäkologie und bleiben Sie gut informiert – ganz bequem per eMail.

Bildnachweise