A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment MENOS 1: Trial protocolReport as inadecuate




A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment MENOS 1: Trial protocol - Download this document for free, or read online. Document in PDF available to download.

BMC Cancer

, 11:44

First Online: 31 January 2011Received: 18 November 2010Accepted: 31 January 2011DOI: 10.1186-1471-2407-11-44

Cite this article as: Mann, E., Smith, M., Hellier, J. et al. BMC Cancer 2011 11: 44. doi:10.1186-1471-2407-11-44

Abstract

BackgroundThis trial aims to evaluate the effectiveness of a group cognitive behavioural intervention to alleviate menopausal symptoms hot flushes and night sweats in women who have had breast cancer treatment. Hot flushes and night sweats are highly prevalent but challenging to treat in this population. Cognitive behaviour therapy has been found to reduce these symptoms in well women and results of an exploratory trial suggest that it might be effective for breast cancer patients. Two hypotheses are tested:

Compared to usual care, group cognitive behavioural therapy will:

1. Significantly reduce the problem rating and frequency of hot flushes and nights sweats after six weeks of treatment and at six months post-randomisation.

2. Improve mood and quality of life after six weeks of treatment and at six months post-randomisation.

Methods-DesignNinety-six women who have completed their main treatment for breast cancer and who have been experiencing problematic hot flushes and night sweats for over two months are recruited into the trial from oncology and breast clinics in South East London. They are randomised to either six weekly group cognitive behavioural therapy Group CBT sessions or to usual care. Group CBT includes information and discussion about hot flushes and night sweats in the context of breast cancer, monitoring and modifying precipitants, relaxation and paced respiration, stress management, cognitive therapy for unhelpful thoughts and beliefs, managing sleep and night sweats and maintaining changes.

Prior to randomisation women attend a clinical interview, undergo 24-hour sternal skin conductance monitoring, and complete questionnaire measures of hot flushes and night sweats, mood, quality of life, hot flush beliefs and behaviours, optimism and somatic amplification. Post-treatment measures sternal skin conductance and questionnaires are collected six to eight weeks later and follow-up measures questionnaires and a use of medical services measure at six months post-randomisation.

DiscussionMENOS 1 is the first randomised controlled trial of cognitive behavioural therapy for hot flushes and night sweats that measures both self-reported and physiologically indexed symptoms. The results will inform future clinical practice by developing an evidence-based, non-medical treatment, which can be delivered by trained health professionals.

Trial RegistrationCurrent Controlled Trials ISRCTN13771934

AbbreviationsCBTCognitive behavioural therapy

HF-NShot flushes and-or night sweats

HFRSHot flush rating scale

HFBSHot flush beliefs scale

SF-36General Health Survey Short form 36

WHQWomen-s Health Questionnaire

LOT RRevised Life Orientation Test

TSCTrial Steering Committee

DMCData Management Committee

NHSNational Health Service

UKCRNUnited Kingdom Cancer Research Network

SELCRNSouth East London Cancer Research Network

RCTRandomised controlled trial

SSCSternal skin conductance

HTHormone therapy previously termed hormone replacement therapy or HRT.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2407-11-44 contains supplementary material, which is available to authorized users.

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Author: Eleanor Mann - Melanie Smith - Jennifer Hellier - Myra S Hunter

Source: https://link.springer.com/



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