Evidence map›Paper›PMID 42108483›Full record

ArticleTrials2026

Optimising a behavioural intervention to support endocrine therapy adherence for women with breast cancer: protocol for the ROSETA optimisation factorial randomised controlled trial.

Sophie M C Green, Emma McNaught, Christopher D Graham, Aaron Dowse, Hollie Wilkes, Pei Loo Ow, Elizabeth Travis, Robbie Foy, David P French, Louise H Hall and 14 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

24 authors.

Sophie M C GreenLeeds Institute of Health Science, University of Leeds, Leeds, LS2 9NL, UK.
Emma McNaughtClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9NL, UK.
Christopher D GrahamDepartment of Psychological Sciences and Health, University of Strathclyde, Glasgow, G1 1QE, UK.
Aaron DowseClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9NL, UK.
Hollie WilkesClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9NL, UK.
Pei Loo OwClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9NL, UK.
Elizabeth TravisLeeds Institute of Health Science, University of Leeds, Leeds, LS2 9NL, UK.
Robbie FoyLeeds Institute of Health Science, University of Leeds, Leeds, LS2 9NL, UK.
David P FrenchDivision of Psychology and Mental Health, University of Manchester, Manchester, M13 9PL, UK.
Louise H HallLeeds Institute of Health Science, University of Leeds, Leeds, LS2 9NL, UK.
Rebecca WalwynClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9NL, UK.
Florence DayClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9NL, UK.
Christopher TaylorClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9NL, UK.
Andrew CarterClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9NL, UK.
Daniel HowdonLeeds Institute of Health Science, University of Leeds, Leeds, LS2 9NL, UK.
Jane ClarkDepartment of Clinical and Health Psychology, Leeds Teaching Hospitals NHS Trust, Leeds, LS9 7TF, UK.
Jo WallerWolfson Institute of Population Health, Queen Mary University of London, London, E13 8SP, UK.
Jacqueline BuxtonIndependent, Leeds, UK.
Sally J L MooreIndependent, Leeds, UK.
Catherine ParbuttMedicines Management and Pharmacy Services, Leeds Teaching Hospitals NHS Trust, Leeds, LS9 7TF, UK.
Galina VelikovaLeeds Institute of Medical Research, University of Leeds, Leeds, LS9 7TF, UK.
Amanda FarrinClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9NL, UK.
Michelle Collinson *Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9NL, UK.
Samuel G Smith *Leeds Institute of Health Science, University of Leeds, Leeds, LS2 9NL, UK. s.smith1@leeds.ac.uk.ORCID http://orcid.org/0000-0003-1983-4470

Funding

National Institute for Health and Care Research NIHR300588National Institute for Health and Care Research NIHR301709National Institute for Health and Care Research NIHR305132Yorkshire Cancer Research L389SS
6 · The paper itself

Abstract

backgroundAdjuvant endocrine therapy (AET) reduces breast cancer recurrence and mortality. However, up to three quarters of women with breast cancer do not take AET as prescribed. Existing interventions to support adherence have shown limited effectiveness and often do not target the range of barriers to appropriate AET use. We developed four intervention components targeting barriers to AET adherence: Short Message Service (SMS) messages targeting forgetfulness, an information leaflet targeting medication beliefs, a self-management website targeting side-effects, and an acceptance and commitment therapy-based guided self-help programme targeting psychological flexibility. In the preparation phase of the Multiphase Optimisation Strategy (MOST), we conducted an external pilot optimisation trial. We met predefined progression criteria regarding consent, component adherence and availability of outcome measures, and concluded progression to an optimisation randomised controlled trial (O-RCT) was warranted. Our primary aim is to optimise the intervention package to support adherence to AET in women with early-stage breast cancer.

methodsWe will conduct a multi-centre, individually randomised superiority O-RCT using a 2 DISCUSSION: Within the optimisation phase of the MOST framework, this trial, using a complex factorial design, will enable us to build a more effective, affordable, scalable and efficient intervention package to support AET adherence in women with breast cancer. This approach will advance intervention science by simultaneously testing the mechanisms through which the intervention components are operating.

trial registrationInternational Standard Randomised Controlled Trial Number ISRCTN17334319. Registered on 02/02/2024.

Indexed as

Antineoplastic Agents, HormonalBehavior TherapyBreast NeoplasmsMedication AdherenceAdherence InterventionsChemotherapy, AdjuvantEquivalence Trials as TopicFemaleHealth Knowledge, Attitudes, PracticeHumansMulticenter Studies as TopicText MessagingTime FactorsTreatment OutcomeAntineoplastic Agents, HormonalAcceptance and commitment therapyAdjuvant endocrine therapyBreast cancerFactorial trialMedication adherenceMultiphase Optimisation StrategyOptimisation trialScreening trialText messaging

Identifiers

PMID42108483
PMCPMC13330054

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.