Evidence map›Paper›PMID 37430353›Full record

Trial reportTrials2023

A multicentre randomised controlled trial of a guided self-help cognitive behavioural therapy to MANage the impact of hot flushes and night sweats in patients with prostate CANcer undergoing androgen deprivation therapy (MANCAN2).

Simon Crabb, Alannah Morgan, Myra S Hunter, Evgenia Stefanopoulou, Gareth Griffiths, Alison Richardson, Deborah Fenlon, Louisa Fleure, James Raftery, Cherish Boxall and 7 more

Open access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.3field-weighted citation impact, top 17% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. 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

17 authors at 7 institutions in 1 country.

Simon CrabbSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Alannah MorganSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK. A.J.Morgan@soton.ac.uk.ORCID http://orcid.org/0000-0002-0262-3135
Myra S HunterKings College London, Institute of Psychiatry, Psychology and Neuroscience, Kings College, London, UK.
Evgenia StefanopoulouTurning Point - Registered Charity, London, UK.
Gareth GriffithsSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Alison RichardsonUniversity Hospital Southampton NHS Foundation Trust, Southampton, UK.
Deborah FenlonSwansea University, Faculty of Medicine, Health and Life Sciences, Swansea University, Swansea, Wales.
Louisa FleureGuys and St Thomas NHS Foundation Trust, St Thomas Hospital Westminster Bridge Road, London, UK.
James RafteryUniversity of Southampton, Southampton, UK.
Cherish BoxallSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Sam WildingSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Jacqueline NuttallSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Zina EmintonSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Emma TiltSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Alice O'NeillSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Roger BaconProstate Cancer Support Organisation (PCaSO), Emsworth, UK.
Jonathan MartinResearch Department of Primary Care and Population Health, University College London, London, UK.
University of Southampton · GBUniversity Hospital Southampton NHS Foundation Trust · GBKing's College London · GBProstate Cancer UK · GBSt Thomas' Hospital · GBSwansea University · GBUniversity College London · GB

Funding

Cancer Research UK 25352
6 · The paper itself

Abstract

backgroundAndrogen deprivation therapy (ADT) is prescribed to almost half of all men diagnosed with prostate cancer. Although ADT is effective treatment, with virtually all men with advanced disease showing initial clinical response, it is associated with troublesome side effects including hot flushes and night sweats (HFNS). HFNS can be both frequent and severe and can have a significant impact on quality of life (QoL). They can occasionally be so debilitating that patients stop ADT altogether, despite the increased risk of disease relapse or death. Previous research has found that guided self-help cognitive behavioural therapy (CBT) can be effective in reducing HFNS due to ADT when delivered by a clinical psychologist. MANCAN2 aims test whether we can train the existing NHS Prostate Cancer Nurse Specialist (CNS) team to deliver guided self-help CBT and whether it is effective in reducing the impact of HFNS in men undergoing ADT.

methodsMANCAN2 is a phase III multicentre randomised controlled trial and process evaluation. Between 144 and 196 men with prostate cancer who are currently receiving ADT and are experiencing problematic HFNS will be individually randomised in a 1:1 ratio in groups of 6-8 participants to either treatment as usual (TAU) or participation in the guided self-help CBT intervention plus TAU. A process evaluation using the normalisation process theory (NPT) framework will be conducted, to understand the CNS team's experiences of delivering the intervention and to establish the key influencers to its implementation as a routine practice service. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost-effectiveness of the intervention and participant adherence to the trial intervention will also be assessed. DISCUSSION: MANCAN2 will advance the program of work already conducted in development of management strategies for HFNS. This research will determine whether the severity of ADT-induced HFNS in men with prostate cancer can be reduced by a guided self-help CBT intervention, delivered by the existing NHS prostate cancer CNS team, within a multicentre study. The emphasis on this existing team, if successful, should facilitate translation through to implementation in routine practice.

trial registrationISRCTN reference 58720120 . Registered 13 December 2022.

Indexed as

Cognitive Behavioral TherapyProstatic NeoplasmsAndrogen AntagonistsAndrogensHot FlashesHumansMaleNeoplasm Recurrence, LocalQuality of LifeSweatAndrogen AntagonistsAndrogensAndrogen deprivation therapyCancer nurse specialistCognitive behavioural therapyHot flushes and night sweatsNormalisation process theoryProcess evaluationProstate cancerQuality of lifeRandomised control trialStudy within a trial (SWAT)

Identifiers

PMID37430353
PMCPMC10332063
OpenAlexW4383721511

What OpenQuestion holds

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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.