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    Can 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

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    Authors
    Bhattacharya, I. S.
    Haviland, J. S.
    Turner, L.
    Stobart, H.
    Balasopoulou, A.
    Stones, L.
    Kirby, A. M.
    Kirwan, Cliona C
    Coles, C. E
    Bliss, J. M.
    Affiliation
    The Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU), London, UK.
    Issue Date
    2021
    
    Metadata
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    Abstract
    Background: 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. Methods: 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. Results: 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. Conclusion: 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.
    Citation
    Bhattacharya IS, Haviland JS, Turner L, Stobart H, Balasopoulou A, Stones L, et al. Can 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. Trials . 2021 Jun 14;22(1).
    Journal
    Trials
    URI
    http://hdl.handle.net/10541/624276
    DOI
    10.1186/s13063-021-05345-y
    PubMed ID
    34127033
    Additional Links
    https://dx.doi.org/10.1186/s13063-021-05345-y
    Type
    Other
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1186/s13063-021-05345-y
    Scopus Count
    Collections
    All Paterson Institute for Cancer Research

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