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A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment (MENOS 1): trial protocol.

Mann E, Smith M, Hellier J, Hunter MS - BMC Cancer (2011)

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

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Psychology at Guy's, Institute of Psychiatry, King's College London, 5th Floor Bermondsey Wing, Guy's Campus, London SE1 9RT, UK.

ABSTRACT

Background: This 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/design: Ninety-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.

Discussion: MENOS 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 registration: Current Controlled Trials ISRCTN13771934.

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Related in: MedlinePlus

Description of overall trial design.
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Figure 1: Description of overall trial design.

Mentions: The study design is shown in Figure 1. It is a randomised controlled trial of Group CBT for HF/NS in women who have completed treatment for breast cancer. Participants are block-randomised to receive either usual care (access to clinic support) or to usual care plus six weekly sessions of Group CBT (herein referred to as Group CBT). The Group CBT was developed from previous work and an exploratory trial [45,50] and is specified in a treatment manual. Group CBT is delivered by a clinical psychologist in this trial, but the treatment is designed to be facilitated by appropriately trained and supervised health professionals. Post-treatment assessment is conducted 7-9 weeks post-randomisation (0-2 weeks after 6 weeks of treatment or usual care). Follow up assessment is conducted 6 months post-randomisation. The primary outcome is problem rating of HF/NS at post-treatment assessment. The trial is conducted in compliance with the Helsinki Declaration [51] and is badged with the National Cancer Research Network (UKCRN; Study ID: 4975). NHS REC approval has been granted (South East London 2 REC, ref: 08/H0802/106) and local ethics and R&D approval has been obtained for recruitment of breast cancer patients from all hospitals in the South East London Cancer Research Network (SELCRN). The trial is registered with Current Controlled Trials (ISRCTN13771934). A trial steering committee (TSC) has agreed the research protocol and monitors implementation. Data and participant welfare are monitored by a data management committee (DMC).


A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment (MENOS 1): trial protocol.

Mann E, Smith M, Hellier J, Hunter MS - BMC Cancer (2011)

Description of overall trial design.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3045984&req=5

Figure 1: Description of overall trial design.
Mentions: The study design is shown in Figure 1. It is a randomised controlled trial of Group CBT for HF/NS in women who have completed treatment for breast cancer. Participants are block-randomised to receive either usual care (access to clinic support) or to usual care plus six weekly sessions of Group CBT (herein referred to as Group CBT). The Group CBT was developed from previous work and an exploratory trial [45,50] and is specified in a treatment manual. Group CBT is delivered by a clinical psychologist in this trial, but the treatment is designed to be facilitated by appropriately trained and supervised health professionals. Post-treatment assessment is conducted 7-9 weeks post-randomisation (0-2 weeks after 6 weeks of treatment or usual care). Follow up assessment is conducted 6 months post-randomisation. The primary outcome is problem rating of HF/NS at post-treatment assessment. The trial is conducted in compliance with the Helsinki Declaration [51] and is badged with the National Cancer Research Network (UKCRN; Study ID: 4975). NHS REC approval has been granted (South East London 2 REC, ref: 08/H0802/106) and local ethics and R&D approval has been obtained for recruitment of breast cancer patients from all hospitals in the South East London Cancer Research Network (SELCRN). The trial is registered with Current Controlled Trials (ISRCTN13771934). A trial steering committee (TSC) has agreed the research protocol and monitors implementation. Data and participant welfare are monitored by a data management committee (DMC).

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

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Psychology at Guy's, Institute of Psychiatry, King's College London, 5th Floor Bermondsey Wing, Guy's Campus, London SE1 9RT, UK.

ABSTRACT

Background: This 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/design: Ninety-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.

Discussion: MENOS 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 registration: Current Controlled Trials ISRCTN13771934.

Show MeSH
Related in: MedlinePlus