Can nurse delivered cognitive behavioural therapy reduce the impact of hot flushes and night sweats in women who have had breast cancer?

ISRCTN	ISRCTN12824632
DOI	https://doi.org/10.1186/ISRCTN12824632
Protocol serial number	33060
Sponsor	University of Southampton
Funder	Breast Cancer Now

Submission date: 04/01/2017
Registration date: 25/01/2017
Last edited: 15/09/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-cognitive-behavioural-therapy-to-reduce-the-impact-of-hot-flushes-and-night

Contact information

Dr Emma Kirkpatrick
Public

Southampton Clinical Trials Unit
University of Southampton
MP131, Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

ORCID ID	0000-0002-3099-1605

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment, Psychological & Behavioural, Complex Intervention
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A multicentre randomised controlled trial of a breast care nurse delivered cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flushes in women with breast cancer
Study acronym	MENOS 4
Study objectives	The aim of this study is to evaluate whether group cognitive behavioural therapy (CBT) delivered by NHS breast care nurses can effectively reduce the impact of hot flushes in women who have completed treatment for breast cancer.
Ethics approval(s)	South Central – Hampshire A Research Ethics Committee, 17/08/2016, ref: 16/SC/0364
Health condition(s) or problem(s) studied	Specialty: Cancer, Primary sub-specialty: Breast Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasm of breast
Intervention	Randomised Controlled Trial: Women will be randomly allocated 1:1 to one of two groups. Investigative treatment (Group CBT) only: Patients allocated to receive group CBT treatment will be invited to attend six therapy sessions, one per week, at or near their local hospital. Sessions will be led by a trained breast care nurse, following a structured manual, and will last 90 minutes each. These sessions will be recorded to check the quality of the session delivered. Some participants will also be asked to take part in face-to-face interviews to ask some more questions about how they felt about the therapy and get feedback about things not covered by the questionnaires. Approximately 1-2 people from each group will be invited to take part in these interviews. Standard care only: Patients allocated to receive standard care. They will not be invited to group therapy sessions but at the end of the study, will be offered a booklet and CD that includes the same information delivered through group CBT sessions. A one-to-one meeting with a breast care nurse to discuss the main parts of the booklet may be arranged, followed by two follow up telephone calls to discuss progress and address any problems. Participants in both groups will be sent a questionnaire booklet to complete at weeks 9 and 26. Some participants who receive the group CBT intervention will also be invited to take part in optional interviews. Process Evaluation: A group evaluation questionnaire will be administered at the end of the six-week intervention to those participants in the intervention arm. Interviews will be conducted with patients and key stakeholders from each of the study centres at the completion of the intervention. Semi structured interview schedules will be developed, guided by consideration of the four areas identified through Normalisation Process Theory. An experienced clinical psychologist, who is independent of the study team, will rate a random selection of group session recordings and rate them for adherence to the treatment manual.
Intervention type	Other
Primary outcome measure(s)	Randomised Controlled Trial: Impact of hot flushes and night sweats is measured using the Hot Flush and Night Sweats (HFNS) Problem Rating (1–10) at baseline and 26 weeks Process Evaluation: Acceptability of intervention is assessed through participant interviews, fidelity ratings of recordings of the intervention, an unvalidated questionnaire and session attendance figures at study end.
Key secondary outcome measure(s)	1. Impact of hot flushes and night sweats is measured using the Hot Flush and Night Sweats (HFNS) Problem Rating (1–10) at baseline and 9 weeks 2. Sleep quality is measured using the Pittsburgh Sleep Quality Index at baseline, 9 and 26 weeks 3. Impact of hot flushes on daily activities and overall quality of life is measured using the Hot flash related daily interference scale at baseline, 9 and 26 weeks 4. Anxiety is measured using the Generalised Anxiety Disorder Questionnaire at baseline, 9 and 26 weeks 5. Depression is measured using the Patient Health Questionnaire at baseline, 9 and 26 weeks 6. Health-related quality of life is measured using the FACT B + ES at baseline,9 and 26 weeks 7. Hot flush beliefs and behaviours is measured using the Hot Flush Beliefs and Behaviour Scale (Short Form) at baseline, 9 and 26 weeks 8. Quality of life is measured using the EQ-5D-5L at baseline, 3, 6, 9 and 26 weeks
Completion date	03/01/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	Female
Target sample size at registration	160
Total final enrolment	130
Key inclusion criteria	Randomised controlled trial: 1. Women with primary breast cancer or DCIS 2. Women who have completed primary surgery radiotherapy and chemotherapy (may still be receiving adjuvant endocrine therapy or Herceptin) 3. Aged 16 years and over 4. Experiencing seven or more problematic HFNS/week, with an overall problem rating score of 4/10 or more 5. Ability and willingness to attend group sessions 6. Written informed consent Process evaluation: 1. BCNs delivering the intervention (2 from each centre) 2. Purposively selected participants from the intervention arm who have consented to be interviewed (2 from each centre) 3. Managers and medical staff from participating centres, who are responsible for breast care services (1 manager and 1 member of the medical team from each centre)
Key exclusion criteria	Randomised controlled trial: 1. Benign breast disease 2. Metastatic disease 3. Current use of other therapies to help with HFNS, e.g. acupuncture, hypnosis and mindfulness Process evaluation: Participants who have not indicated that they are happy to be interviewed on the Consent Form.
Date of first enrolment	01/02/2017
Date of final enrolment	01/03/2018

Locations

Countries of recruitment

United Kingdom
England
Wales

Study participating centres

Walsall Manor Hospital

Moat Road
Walsall
WS2 9PS
United Kingdom

York Hospital

Wigginton Road
York
YO31 8HE
United Kingdom

Yeovil District Hospital

Higher Kingston
Yeovil
BA21 4AT
United Kingdom

Queen Alexandra Hospital

Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom

Luton and Dunstable University Hospital

Lewsey Road
Luton
LU4 0DZ
United Kingdom

Royal Glamorgan Hospital

Ynysmaerdy
Llantrisant
CF72 8XR
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/10/2020	20/05/2021	Yes	No
Protocol article	protocol	08/05/2018		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			15/09/2022	No	Yes

Editorial Notes

02/09/2022: Cancer Research UK plain English results link added.
20/05/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
10/05/2018: Publication reference added.
06/06/2017: Cancer Help UK lay summary link added to plain English summary field.