Cargando…

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

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). PRIME...

Descripción completa

Detalles Bibliográficos
Autores principales: Bhattacharya, Indrani S., Haviland, Joanne S., Turner, Lesley, Stobart, Hilary, Balasopoulou, Ada, Stones, Liba, Kirby, Anna M., Kirwan, Cliona C., Coles, Charlotte E., Bliss, Judith M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8202048/
https://www.ncbi.nlm.nih.gov/pubmed/34127033
http://dx.doi.org/10.1186/s13063-021-05345-y
_version_ 1783707906597715968
author Bhattacharya, Indrani S.
Haviland, Joanne S.
Turner, Lesley
Stobart, Hilary
Balasopoulou, Ada
Stones, Liba
Kirby, Anna M.
Kirwan, Cliona C.
Coles, Charlotte E.
Bliss, Judith M.
author_facet Bhattacharya, Indrani S.
Haviland, Joanne S.
Turner, Lesley
Stobart, Hilary
Balasopoulou, Ada
Stones, Liba
Kirby, Anna M.
Kirwan, Cliona C.
Coles, Charlotte E.
Bliss, Judith M.
author_sort Bhattacharya, Indrani S.
collection PubMed
description 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05345-y.
format Online
Article
Text
id pubmed-8202048
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-82020482021-06-15 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 Bhattacharya, Indrani S. Haviland, Joanne S. Turner, Lesley Stobart, Hilary Balasopoulou, Ada Stones, Liba Kirby, Anna M. Kirwan, Cliona C. Coles, Charlotte E. Bliss, Judith M. Trials Research 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05345-y. BioMed Central 2021-06-14 /pmc/articles/PMC8202048/ /pubmed/34127033 http://dx.doi.org/10.1186/s13063-021-05345-y Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Bhattacharya, Indrani S.
Haviland, Joanne S.
Turner, Lesley
Stobart, Hilary
Balasopoulou, Ada
Stones, Liba
Kirby, Anna M.
Kirwan, Cliona C.
Coles, Charlotte E.
Bliss, Judith M.
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8202048/
https://www.ncbi.nlm.nih.gov/pubmed/34127033
http://dx.doi.org/10.1186/s13063-021-05345-y
work_keys_str_mv AT bhattacharyaindranis canpatientdecisionaidsreducedecisionalconflictinadeescalationofbreastradiotherapyclinicaltrialtheprimetimestudywithinatrialimplementedusingaclustersteppedwedgetrialdesign
AT havilandjoannes canpatientdecisionaidsreducedecisionalconflictinadeescalationofbreastradiotherapyclinicaltrialtheprimetimestudywithinatrialimplementedusingaclustersteppedwedgetrialdesign
AT turnerlesley canpatientdecisionaidsreducedecisionalconflictinadeescalationofbreastradiotherapyclinicaltrialtheprimetimestudywithinatrialimplementedusingaclustersteppedwedgetrialdesign
AT stobarthilary canpatientdecisionaidsreducedecisionalconflictinadeescalationofbreastradiotherapyclinicaltrialtheprimetimestudywithinatrialimplementedusingaclustersteppedwedgetrialdesign
AT balasopoulouada canpatientdecisionaidsreducedecisionalconflictinadeescalationofbreastradiotherapyclinicaltrialtheprimetimestudywithinatrialimplementedusingaclustersteppedwedgetrialdesign
AT stonesliba canpatientdecisionaidsreducedecisionalconflictinadeescalationofbreastradiotherapyclinicaltrialtheprimetimestudywithinatrialimplementedusingaclustersteppedwedgetrialdesign
AT kirbyannam canpatientdecisionaidsreducedecisionalconflictinadeescalationofbreastradiotherapyclinicaltrialtheprimetimestudywithinatrialimplementedusingaclustersteppedwedgetrialdesign
AT kirwanclionac canpatientdecisionaidsreducedecisionalconflictinadeescalationofbreastradiotherapyclinicaltrialtheprimetimestudywithinatrialimplementedusingaclustersteppedwedgetrialdesign
AT colescharlottee canpatientdecisionaidsreducedecisionalconflictinadeescalationofbreastradiotherapyclinicaltrialtheprimetimestudywithinatrialimplementedusingaclustersteppedwedgetrialdesign
AT blissjudithm canpatientdecisionaidsreducedecisionalconflictinadeescalationofbreastradiotherapyclinicaltrialtheprimetimestudywithinatrialimplementedusingaclustersteppedwedgetrialdesign
AT canpatientdecisionaidsreducedecisionalconflictinadeescalationofbreastradiotherapyclinicaltrialtheprimetimestudywithinatrialimplementedusingaclustersteppedwedgetrialdesign