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dc.contributor.authorBhattacharya, Indrani S
dc.contributor.authorHaviland, Joanne S
dc.contributor.authorTurner, Lesley
dc.contributor.authorStobart, Hilary
dc.contributor.authorBalasopoulou, Ada
dc.contributor.authorStones, Liba
dc.contributor.authorKirby, Anna M
dc.contributor.authorKirwan, Cliona C
dc.contributor.authorColes, Charlotte E
dc.contributor.authorBliss, Judith M
dc.date.accessioned2021-07-28T09:16:20Z
dc.date.available2021-07-28T09:16:20Z
dc.date.issued2021-06-14
dc.identifier.issn1745-6215
dc.identifier.otherPMC8202048
dc.identifier.other34127033
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/325681
dc.description.abstract<h4>Background</h4>For patients with early breast cancer considered at very-low risk of local relapse, risks of radiotherapy may outweigh the benefits. Decisions regarding treatment omission can lead to patient uncertainty (decisional conflict), which may be lessened with patient decision aids (PDA). PRIMETIME (ISRCTN 41579286) is a UK-led biomarker-directed study evaluating omission of adjuvant radiotherapy in breast cancer; an embedded Study Within A Trial (SWAT) investigated whether PDA reduces decisional conflict using a cluster stepped-wedge trial design.<h4>Methods</h4>PDA diagrams and a video explaining risks and benefits of radiotherapy were developed in close collaboration between patient advocates and PRIMETIME trialists. The SWAT used a cluster stepped-wedge trial design, where each cluster represented the radiotherapy centre and referring peripheral centres. All clusters began in the standard information group (patient information and diagrams) and were randomised to cross-over to the enhanced information group (standard information plus video) at 2, 4 or 6 months. Primary endpoint was the decisional conflict scale (0-100, higher scores indicating greater conflict) which was assessed on an individual participant level. Multilevel mixed effects models used a random effect for cluster and a fixed effect for each step to adjust for calendar time and clustering. Robust standard errors were also adjusted for the clustering effect.<h4>Results</h4>Five hundred twenty-one evaluable questionnaires were returned from 809 eligible patients (64%) in 24 clusters between April 2018 and October 2019. Mean decisional conflict scores in the standard group (N = 184) were 10.88 (SD 11.82) and 8.99 (SD 11.82) in the enhanced group (N = 337), with no statistically significant difference [mean difference - 1.78, 95%CI - 3.82-0.25, p = 0.09]. Compliance with patient information and diagrams was high in both groups although in the enhanced group only 121/337 (36%) reported watching the video.<h4>Conclusion</h4>The low levels of decisional conflict in PRIMETIME are reassuring and may reflect the high-quality information provision, such that not everyone required the video. This reinforces the importance of working with patients as partners in clinical trials especially in the development of patient-centred information and decision aids.
dc.languageeng
dc.rightsAttribution 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.sourceessn: 1745-6215
dc.sourcenlmid: 101263253
dc.subjectCancer
dc.subjectBreast
dc.subjectCluster
dc.subjectRadiotherapy
dc.subjectOncology
dc.subjectSwat
dc.subjectDe-escalation
dc.subjectStepped-wedge
dc.subjectDecisional-conflict
dc.subjectHumans
dc.subjectNeoplasm Recurrence, Local
dc.subjectChronic Disease
dc.subjectDecision Making
dc.subjectDecision Support Techniques
dc.subjectResearch Design
dc.subjectSurveys and Questionnaires
dc.titleCan patient decision aids reduce decisional conflict in a de-escalation of breast radiotherapy clinical trial? The PRIMETIME Study Within a Trial implemented using a cluster stepped-wedge trial design.
dc.typeArticle
dc.date.updated2021-07-28T09:16:19Z
prism.issueIdentifier1
prism.publicationNameTrials
prism.volume22
dc.identifier.doi10.17863/CAM.73138
rioxxterms.versionofrecord10.1186/s13063-021-05345-y
rioxxterms.versionVoR
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0/
dc.contributor.orcidBhattacharya, Indrani S [0000-0002-2983-1305]
dc.contributor.orcidBliss, Judith M [0000-0001-7957-7424]
pubs.funder-project-idCancer Research UK (PRIMETIME Trial Grant (C17918/A20015))


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Attribution 4.0 International
Except where otherwise noted, this item's licence is described as Attribution 4.0 International