Condition category
Cancer
Date applied
04/01/2017
Date assigned
25/01/2017
Last edited
06/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Dr Emma Kirkpatrick

ORCID ID

http://orcid.org/0000-0002-3099-1605

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33060

Study information

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

Acronym

MENOS 4

Study hypothesis

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

South Central – Hampshire A Research Ethics Committee, 17/08/2016, ref: 16/SC/0364

Study design

Randomised; Interventional; Design type: Treatment, Psychological & Behavioural, Complex Intervention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase III

Drug names

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

04/01/2016

Overall trial end date

03/01/2019

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 160; UK Sample Size: 160

Participant 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.

Recruitment start date

01/02/2017

Recruitment end date

01/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Walsall Manor Hospital
Moat Road
Walsall
WS2 9PS
United Kingdom

Trial participating centre

York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom

Trial participating centre

Yeovil District Hospital
Higher Kingston
Yeovil
BA21 4AT
United Kingdom

Trial participating centre

Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom

Trial participating centre

Luton and Dunstable University Hospital
Lewsey Road
Luton
LU4 0DZ
United Kingdom

Trial participating centre

Royal Glamorgan Hospital
Ynysmaerdy
Llantrisant
CF72 8XR
United Kingdom

Sponsor information

Organisation

University of Southampton

Sponsor details

Research & Innovation Services
University Road
Southampton
SO17 1BJ
United Kingdom
+44 23 8059 8673
rgoinfo@soton.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Breast Cancer Now

Alternative name(s)

BCN

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal around 6 months after trial end.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

03/07/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

06/06/2017: Cancer Help UK lay summary link added to plain English summary field 10/04/2017: Internal review