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Clinical Trial
. 2018 May 8;18(1):63.
doi: 10.1186/s12905-018-0550-z.

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

Deborah Fenlon  1 , Jacqueline Nuttall  2 , Carl May  3 , James Raftery  4 , Jo Fields  5 , Emma Kirkpatrick  2 , Julia Abab  2 , Mary Ellis  2 , Taylor Rose  2 , Priya Khambhaita  6 , Angeliki Galanopoulou  2 , Tom Maishman  2 , Jo Haviland  7 , Gareth Griffiths  2 , Lesley Turner  8 , Myra Hunter  9
Affiliations
Clinical Trial

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

Deborah Fenlon et al. BMC Womens Health. .

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.

Keywords: Breast cancer; CBT; Hot flushes; Menopause; Night sweats; Normalisation process theory; Nurses; Training.

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Conflict of interest statement

Ethics approval and consent to participate

The University of Southampton sponsors this study. The study protocol has received ethical and governance approvals from the National Research Ethics Service South Central - Hampshire A Research Ethics Committee and HRA (ref. [16]/SC/0364), and from the University of Southampton ref. number: 19245. All participants provide written informed consent to participate and are free to withdraw at any time.

Competing interests

The authors declare that they have no competing interests.

Professor Deborah Fenlon has received an honorarium from Roche for teaching.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schedule of observations and procedures
Fig. 2
Fig. 2
Study Schema
See this image and copyright information in PMC

References

    1. Ayers B, et al. Effectiveness of group and self-help cognitive behaviour therapy in reducing problematic menopausal hot flushes and night sweats (MENOS 2): a randomized controlled trial. Menopause. 2012;19(7):749–759. doi: 10.1097/gme.0b013e31823fe835. - DOI - PubMed
    1. Balabanovic J, Ayers B, Hunter MS. Cognitive behaviour therapy for menopausal hot flushes and night sweats: a qualitative analysis of women's experiences of group and self-help CBT. Behav Cogn Psychother. 2013;41(4):441–457. doi: 10.1017/S1352465812000677. - DOI - PubMed
    1. Beecham & Knapp, 1992 Client socio-demographic and service receipt inventory - European version: development of an instrument for international research. Br J Psychiatry. 2000;177(39):s28–s33. - PubMed
    1. Brady MJ, et al. Reliability and validity of the functional assessment of Cancer therapy-breast quality-of-life instrument. J Clin Oncol. 1997;15(3):974–986. doi: 10.1200/JCO.1997.15.3.974. - DOI - PubMed
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101. doi: 10.1191/1478088706qp063oa. - DOI

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