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A randomised controlled trial of three or one breathing technique training sessions for breathlessness in people with malignant lung disease

Johnson, Miriam J.; Kanaan, Mona; Richardson, Gerry; Nabb, Samantha; Torgerson, David; English, Anne; Barton, Rachael; Booth, Sara

Authors

Mona Kanaan

Gerry Richardson

Samantha Nabb

David Torgerson

Anne English

Rachael Barton

Sara Booth



Abstract

© Johnson et al. Background: About 90 % of patients with intra-thoracic malignancy experience breathlessness. Breathing training is helpful, but it is unknown whether repeated sessions are needed. The present study aims to test whether three sessions are better than one for breathlessness in this population. Methods: This is a multi-centre randomised controlled non-blinded parallel arm trial. Participants were allocated to three sessions or single (1:2 ratio) using central computer-generated block randomisation by an independent Trials Unit and stratified for centre. The setting was respiratory, oncology or palliative care clinics at eight UK centres. Inclusion criteria were people with intrathoracic cancer and refractory breathlessness, expected prognosis ≤3 months, and no prior experience of breathing training. The trial intervention was a complex breathlessness intervention (breathing training, anxiety management, relaxation, pacing, and prioritisation) delivered over three hour-long sessions at weekly intervals, or during a single hour-long session. The main primary outcome was worst breathlessness over the previous 24 hours ('worst'), by numerical rating scale (0 = none; 10 = worst imaginable). Our primary analysis was area under the curve (AUC) 'worst' from baseline to 4 weeks. All analyses were by intention to treat. Results: Between April 2011 and October 2013, 156 consenting participants were randomised (52 three; 104 single). Overall, the 'worst' score reduced from 6.81 (SD, 1.89) to 5.84 (2.39). Primary analysis [n = 124 (79 %)], showed no between-arm difference in the AUC: three sessions 22.86 (7.12) vs single session 22.58 (7.10); P value = 0.83); mean difference 0.2, 95 % CIs (-2.31 to 2.97). Complete case analysis showed a non-significant reduction in QALYs with three sessions (mean difference -0.006, 95 % CIs -0.018 to 0.006). Sensitivity analyses found similar results. The probability of the single session being cost-effective (threshold value of £20,000 per QALY) was over 80 %. Conclusions: There was no evidence that three sessions conferred additional benefits, including cost-effectiveness, over one. A single session of breathing training seems appropriate and minimises patient burden.

Citation

Johnson, M. J., Kanaan, M., Richardson, G., Nabb, S., Torgerson, D., English, A., …Booth, S. (2015). A randomised controlled trial of three or one breathing technique training sessions for breathlessness in people with malignant lung disease. BMC medicine, 13(1), Article 213. https://doi.org/10.1186/s12916-015-0453-x

Journal Article Type Article
Acceptance Date Aug 14, 2015
Online Publication Date Sep 7, 2015
Publication Date 2015-12
Deposit Date Apr 9, 2019
Publicly Available Date Apr 10, 2019
Journal BMC Medicine
Electronic ISSN 1741-7015
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 13
Issue 1
Article Number 213
DOI https://doi.org/10.1186/s12916-015-0453-x
Keywords Breathing training; Breathlessness; Dyspnoea; Cancer; Neoplasm
Public URL https://hull-repository.worktribe.com/output/1569681
Publisher URL https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-015-0453-x
Contract Date Apr 10, 2019

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This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.






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