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 |
| Secondary identifying numbers | 33060 |
- 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
Contact information
Dr Emma Kirkpatrick
Public
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
| Study design | Randomised; Interventional; Design type: Treatment, Psychological & Behavioural, Complex Intervention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 04/01/2016 |
| Completion date | 03/01/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 160; UK Sample Size: 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
- England
- United Kingdom
- Wales
Study participating centres
Walsall Manor Hospital
Moat Road
Walsall
WS2 9PS
United Kingdom
Walsall
WS2 9PS
United Kingdom
York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
York
YO31 8HE
United Kingdom
Yeovil District Hospital
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
Yeovil
BA21 4AT
United Kingdom
Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
Portsmouth
PO6 3LY
United Kingdom
Luton and Dunstable University Hospital
Lewsey Road
Luton
LU4 0DZ
United Kingdom
Luton
LU4 0DZ
United Kingdom
Royal Glamorgan Hospital
Ynysmaerdy
Llantrisant
CF72 8XR
United Kingdom
Llantrisant
CF72 8XR
United Kingdom
Sponsor information
University of Southampton
University/education
University/education
Research & Innovation Services
University Road
Southampton
SO17 1BJ
England
United Kingdom
| Phone | +44 (0)23 8059 8673 |
|---|---|
| rgoinfo@soton.ac.uk | |
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Charity
Breast Cancer Now
Government organisation / Trusts, charities, foundations (both public and private)
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- BCN
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 03/07/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 08/05/2018 | Yes | No | |
| Results article | 01/10/2020 | 20/05/2021 | Yes | No | |
| Plain English results | 15/09/2022 | No | Yes | ||
| HRA research summary | 28/06/2023 | No | No |
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.
