Evidence map›Paper›PMID 36737093›Full record

ArticleBMJ open2023

Refining and optimising a behavioural intervention to support endocrine therapy adherence (ROSETA) in UK women with breast cancer: protocol for a pilot fractional factorial trial.

Samuel G Smith, Sophie M C Green, Rachel Ellison, Robbie Foy, Christopher D Graham, Ellen Mason, David P French, Louise H Hall, Hollie Wilkes, Emma McNaught and 11 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
4.6field-weighted citation impact, top 5% 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

13 citing papers in PubMed, 18 citations in OpenAlex.

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  9. The acceptability of exercise prehabilitation before cancer surgery among patients, family members and health professionals: a mixed methods evaluation.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
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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

21 authors at 4 institutions in 1 country.

Samuel G SmithAcademic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK S.Smith1@leeds.ac.uk.ORCID 0000-0003-1983-4470
Sophie M C GreenAcademic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Rachel EllisonComplex Interventions Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Robbie FoyAcademic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.ORCID 0000-0003-0605-7713
Christopher D GrahamSchool of Psychology, Queens University Belfast, Belfast, UK.
Ellen MasonComplex Interventions Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
David P FrenchSchool of Psychological Sciences, Division of Psychology and Mental Health, University of Manchester, Manchester, UK.ORCID 0000-0002-7663-7804
Louise H HallAcademic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Hollie WilkesComplex Interventions Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Emma McNaughtComplex Interventions Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Erin RaineAcademic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Rebecca WalwynComplex Interventions Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Daniel HowdonAcademic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.ORCID 0000-0001-8052-2893
Jane ClarkDepartment of Clinical and Health Psychology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Nikki RousseauSurgical, Diagnostic and Devices Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Jacqueline BuxtonAcademic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Sally J L MooreAcademic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Catherine ParbuttMedicines Management and Pharmacy Services, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Galina VelikovaLeeds Institute of Medical Research, University of Leeds, Leeds, UK.
Amanda FarrinComplex Interventions Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Michelle CollinsonComplex Interventions Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
University of Leeds · GBLeeds Teaching Hospitals NHS Trust · GBQueen's University Belfast · GBUniversity of Manchester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWomen with breast cancer who do not adhere to adjuvant endocrine therapy (AET) have increased risks of mortality and recurrence. There are multiple barriers to AET adherence, including medication side-effects, beliefs about medication, memory and psychological distress. We developed four intervention components, each targeting a different barrier. This pilot trial is part of the preparation phase of the Multiphase Optimisation Strategy, and aims to establish key trial parameters, establish intervention component adherence, establish availability and feasibility of outcome and process data, estimate variability in planned outcome measures and estimate cost of developing and delivering each intervention component. METHODS AND ANALYSIS: The four intervention components are as follows: short message service text reminders (target: memory); a written information leaflet (target: medication beliefs); a guided self-help Acceptance and Commitment Therapy programme (target: psychological flexibility to reduce distress) and a self-management website (target: side-effect management). To evaluate the feasibility of recruitment, acceptability of the intervention components and the availability of outcome data, we will conduct a multisite, exploratory pilot trial using a 2 ETHICS AND DISSEMINATION: The study was reviewed by the Wales Research Authority Research Ethics Committee 3 (21/WA/0322). Written informed consent will be obtained from all patients before randomisation. The results of this trial will be disseminated in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRTCN10487576.

Indexed as

Acceptance and Commitment TherapyBreast NeoplasmsFemaleHumansMedication AdherenceQuality of LifeRandomized Controlled Trials as TopicUnited KingdomBreast tumoursPREVENTIVE MEDICINEPUBLIC HEALTH

Identifiers

PMID36737093
PMCPMC9900066
OpenAlexW4319078409

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.