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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

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
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

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.

Journal Article
1472-6874
1-10
Fenlon, Deborah
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Nuttall, Jacqueline
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May, Carl
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Raftery, James
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Fields, Jo
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Kirkpatrick, Emma
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Abab, Julia
b4176948-e6e7-4cd0-9237-4260e9f9ec50
Ellis, Mary
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Rose, Taylor
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Khambhaita, Priya
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Galanopoulou, Angeliki
a7a4ffa6-e854-49ef-b55c-994ec2ee751d
Maishman, Tom
c25ab2a0-8a1c-4aa1-9c39-d210762e407d
Haviland, Jo
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Griffiths, Gareth
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Turner, Lesley
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Hunter, Myra
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Fenlon, Deborah
52f9a9f1-1643-449c-9856-258ef563342c
Nuttall, Jacqueline
154aec0a-05f2-4379-918e-9c36767fdc4c
May, Carl
17697f8d-98f6-40d3-9cc0-022f04009ae4
Raftery, James
27c2661d-6c4f-448a-bf36-9a89ec72bd6b
Fields, Jo
2ade3101-8f8f-4e70-9f3c-7f0a2dd86ae6
Kirkpatrick, Emma
ef4472be-90bf-400a-b100-e9d26cb907fc
Abab, Julia
b4176948-e6e7-4cd0-9237-4260e9f9ec50
Ellis, Mary
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Rose, Taylor
ad05dc29-02db-434e-8f06-e88bf09d5adb
Khambhaita, Priya
30115f1a-b0fc-462c-91f3-d52e3a66a7dc
Galanopoulou, Angeliki
a7a4ffa6-e854-49ef-b55c-994ec2ee751d
Maishman, Tom
c25ab2a0-8a1c-4aa1-9c39-d210762e407d
Haviland, Jo
e1e37a07-4c74-4700-9a0b-0fd8924f1ecc
Griffiths, Gareth
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Turner, Lesley
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Hunter, Myra
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Fenlon, Deborah, Nuttall, Jacqueline, May, Carl, Raftery, James, Fields, Jo, Kirkpatrick, Emma, Abab, Julia, Ellis, Mary, Rose, Taylor, Khambhaita, Priya, Galanopoulou, Angeliki, Maishman, Tom, Haviland, Jo, Griffiths, Gareth, Turner, Lesley and Hunter, Myra (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. BMC Women’s Health, 18 (1), 1-10. (doi:10.1186/s12905-018-0550-z).

Record type: Article

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.

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Accepted/In Press date: 10 April 2018
e-pub ahead of print date: 8 May 2018
Published date: 2018
Keywords: Journal Article

Identifiers

Local EPrints ID: 420540
URI: http://eprints.soton.ac.uk/id/eprint/420540
ISSN: 1472-6874
PURE UUID: 1c417fca-4d62-475b-adce-597dcbaf01b4
ORCID for Carl May: ORCID iD orcid.org/0000-0002-0451-2690
ORCID for Emma Kirkpatrick: ORCID iD orcid.org/0000-0002-3099-1605
ORCID for Julia Abab: ORCID iD orcid.org/0000-0002-5292-1042
ORCID for Gareth Griffiths: ORCID iD orcid.org/0000-0002-9579-8021

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Date deposited: 10 May 2018 16:30
Last modified: 27 Jan 2020 13:47

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Contributors

Author: Deborah Fenlon
Author: Jacqueline Nuttall
Author: Carl May ORCID iD
Author: James Raftery
Author: Jo Fields
Author: Emma Kirkpatrick ORCID iD
Author: Julia Abab ORCID iD
Author: Mary Ellis
Author: Taylor Rose
Author: Priya Khambhaita
Author: Angeliki Galanopoulou
Author: Tom Maishman
Author: Jo Haviland
Author: Lesley Turner
Author: Myra Hunter

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