Evidence map›Paper›PMID 41299751›Full record

ArticleTrials2025

Improving outcomeS for Women diagnosed with early breast cancer through adhErence to adjuvant Endocrine Therapy (SWEET): study protocol for a pragmatic randomised control trial of a patient-centred intervention to improve adherence to endocrine therapy in early breast cancer.

Lucy McGeagh, Alice Walker, Louise Hiller, Janet Dunn, Mary Wells, Peter Donnelly, Andrew Wardley, Jane Wolstenholme, Robert Horne, Sarah-Jane Stewart and 20 more

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

Article in Trials, 2025. 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
–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

2 citing papers in PubMed.

  1. Article
  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

30 authors.

Lucy McGeagh *Oxford Institute of Applied Health Research, Oxford Brookes University, Oxford, UK.ORCID http://orcid.org/0000-0002-9226-5115
Alice Walker *Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Louise HillerWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Janet DunnWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Mary WellsImperial College Healthcare NHS Trust, London, UK.
Peter DonnellyTorbay and South Devon NHS Foundation Trust, Torquay, UK.
Andrew WardleyOutreach Research & Innovation Group, Manchester, UK.
Jane WolstenholmeHealth Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Robert HorneResearch Department of Practice and Policy, UCL School of Pharmacy, University College London, London, UK.
Sarah-Jane StewartResearch Department of Practice and Policy, UCL School of Pharmacy, University College London, London, UK.
Jo BrettOxford Institute of Applied Health Research, Oxford Brookes University, Oxford, UK.
Caitriona CahirSchool of Population Health, RCSI University of Medicine and Health Sciences, Dublin, Ireland.
Deborah FenlonProfessor Emerita, Faculty Of Medicine, Health and Life Science, Swansea University, Swansea, UK.
Jan RoseIndependent Cancer Patients' Voice, UK and Cancer Research Advocates Forum-UK, London, UK.
Lesley TurnerIndependent Cancer Patients' Voice, UK and Cancer Research Advocates Forum-UK, London, UK.
Lyndsay HughesKings College London, London, UK.
Adam ToddSchool of Pharmacy, Newcastle University, Newcastle, UK.
Brian NicholsonDepartment of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Phil MawsonTranslational and Clinical Research Institute, Newcastle University, Newcastle, UK.
Ruth NorrisPopulation Health Sciences Institute, Newcastle University, Newcastle, UK.
Sue ThompsonPopulation Health Sciences Institute, Newcastle University, Newcastle, UK.
Helen DakinHealth Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Raegan BarrowsWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Sally KumBreast Cancer Now, London, UK.
Mark TurnerResearch Software Engineering, Newcastle University, Newcastle, UK.
Farah RehmanImperial College Healthcare NHS Trust, London, UK.
Henry CainNewcastle Hospitals NHS Foundation Trust, Newcastle, UK.
Eila Watson *Oxford Institute of Applied Health Research, Oxford Brookes University, Oxford, UK.
Linda Sharp *Population Health Sciences Institute, Newcastle University, Newcastle, UK. linda.sharp@newcastle.ac.uk.
SWEET Research Team

Funding

National Institute for Health and Care Research NIHR200098
6 · The paper itself

Abstract

backgroundAt least 5 years of adjuvant endocrine therapy substantially reduces risks of recurrence and mortality in oestrogen-receptor positive early breast cancer. However, adherence to endocrine therapy is sub-optimal; poor adherence is associated with higher risks of recurrence and death from breast cancer, worse cancer-specific health-related quality-of-life, and increased healthcare costs. The SWEET randomised control trial aims to evaluate effectiveness and cost-effectiveness of the HT&Me intervention in reducing poor adherence to adjuvant endocrine therapy and improve cancer-specific health-related quality-of-life in women with oestrogen-receptor positive early breast cancer.

methodsThis is a UK based, pragmatic, open label randomised control trial. Participants (stages 1-3 oestrogen-receptor positive breast cancer, completed surgery, within 14 weeks of first endocrine therapy prescription; n = 1460) complete a baseline questionnaire, and are randomised to the HT&Me intervention plus usual care, or usual care alone. The HT&Me intervention is evidence-based, theory-informed and patient-centred. It consists of viewing an animation, two consultations with a SWEET study practitioner (a health care professional trained in delivering the intervention) approximately 3 months apart, access to the interactive HT&Me web-app for the 18 months, and regular monthly nudges. All participants complete follow-up questionnaires at 6, 12, and 18 months. A multi-method process evaluation will be conducted involving quantitative analysis exploring mechanisms of action of the intervention, and qualitative interviews with a sample of participants and health care professionals involved in the trial. Primary endpoints are adjuvant endocrine therapy adherence (combined self-report (Medication Adherence Report Scale) and Proportion of Days Covered calculated from prescription encashment records) and cancer-specific health-related quality-of-life (Functional Assessment of Cancer Therapy Scale- General). Secondary endpoints are adjuvant endocrine therapy-specific health-related quality-of-life and within-trial cost-utility analysis which will evaluate cost-effectiveness. DISCUSSION: The SWEET trial seeks to address a significant issue affecting the growing population of breast cancer survivors: poor adherence to adjuvant endocrine therapy. Challenges addressed and resolved within the protocol include the following: capacity at sites to deliver the intervention; variations in breast cancer services nationally; and measuring adherence. This trial has potential to improve quality of life and adherence to endocrine therapy; reducing numbers of recurrences and breast cancer deaths, benefiting women, their families and the health service.

trial registrationISRCTN Number: ISRCTN24852890 registered on 02.08.2023.

Indexed as

Antineoplastic Agents, HormonalBreast NeoplasmsMedication AdherenceChemotherapy, AdjuvantCost-Benefit AnalysisDrug CostsFemaleHumansNeoplasm StagingPatient-Centered CarePragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicReceptors, EstrogenTime FactorsTreatment OutcomeAntineoplastic Agents, HormonalReceptors, EstrogenAdherenceBreast cancerEndocrine therapyInterventionQuality-of-lifeRandomised control trialSelf-management

Identifiers

PMID41299751
PMCPMC12659038

What Socratic 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 Socratic graph.