Evidence map›Paper›PMID 29739384›Full record

Trial reportBMC women's health2018

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.

Deborah Fenlon, Jacqueline Nuttall, Carl May, James Raftery, Jo Fields, Emma Kirkpatrick, Julia Abab, Mary Ellis, Taylor Rose, Priya Khambhaita and 6 more

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC women's health, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Specialist breast care nurses for support of women with breast cancer.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Trial
  3. Trial
  4. Post-treatment adaptation experiences of women breast cancer survivors: a qualitative study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  5. Article
  6. Article
  7. Article
  8. Dermatologic conditions in women receiving systemic cancer therapy.International journal of women's dermatology · 2019
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 7 institutions in 1 country.

Deborah FenlonCollege of Human and Health Sciences, Swansea University, Swansea, UK. D.R.Fenlon@swansea.ac.uk.
Jacqueline NuttallSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Carl MayFaculty of Health Sciences, University of Southampton, Southampton, UK.
James RafteryPrimary Care and Population Sciences, University of Southampton, Southampton, UK.
Jo FieldsPoole Hospital NHS Trust, Poole, UK.
Emma KirkpatrickSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Julia AbabSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.ORCID 0000-0002-5292-1042
Mary EllisSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Taylor RoseSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Priya KhambhaitaPensions Policy Institute, King's College, WC2B 6LE, London, UK.
Angeliki GalanopoulouSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Tom MaishmanSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Jo HavilandRoyal Marsden Clinical Trials Unit, Sutton, UK.
Gareth GriffithsSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Lesley TurnerIndependent Cancer Patients' Voices, London, UK.
Myra HunterKing's College, London, London, UK.
University of Southampton · GBDepartment for Work and Pensions · GBKing's College London · GBPoole Hospital · GBRoyal Marsden NHS Foundation Trust · GBSwansea University · GBThe Patients Association · GB

Funding

Cancer Research UK 15956Cancer Research UK 25352
6 · The paper itself

Abstract

backgroundWomen 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.

methodsThis 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 registrationISRCTN 12824632 . Registered 25-01-2017.

Indexed as

Cognitive Behavioral TherapyPractice Patterns, Nurses'SweatingBreast NeoplasmsCost-Benefit AnalysisFemaleHot FlashesHumansPsychotherapy, GroupResearch DesignBreast cancerCBTHot flushesMenopauseNight sweatsNormalisation process theoryNursesTraining

Identifiers

PMID29739384
PMCPMC5941327
OpenAlexW2799960803

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.