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dc.contributor.authorJohnson, Miriam J
dc.contributor.authorKanaan, Mona
dc.contributor.authorRichardson, Gerry
dc.contributor.authorNabb, Samantha
dc.contributor.authorTorgerson, David
dc.contributor.authorEnglish, Anne
dc.contributor.authorBarton, Rachael
dc.contributor.authorBooth, Sara
dc.date.accessioned2016-09-29T15:08:41Z
dc.date.available2016-09-29T15:08:41Z
dc.date.issued2015-09-07
dc.identifier.citationBMC Medicine. 2015 Sep 07;13(1):213
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/260585
dc.description.abstractAbstract 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. Trial registration Registry: ISRCTN; Trial registration number: ISRCTN49387307; http://www.isrctn.com/ISRCTN49387307 ; registration date: 25/01/2011
dc.rightsAll Rights Reserveden
dc.rights.urihttps://www.rioxx.net/licenses/all-rights-reserved/en
dc.titleA randomised controlled trial of three or one breathing technique training sessions for breathlessness in people with malignant lung disease
dc.typeArticle
dc.date.updated2016-09-29T15:08:41Z
dc.language.rfc3066en
dc.rights.holderJohnson et al.
dc.identifier.doi10.17863/CAM.4819
pubs.declined2017-10-11T13:54:41.479+0100
rioxxterms.versionofrecord10.1186/s12916-015-0453-x


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