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

BMC Medicine

Sara Booth³  Rachael Barton⁴  Anne English¹  David Torgerson⁶  Samantha Nabb⁷  Gerry Richardson⁵  Mona Kanaan⁶  Miriam J Johnson² 

[1] Humber NHS Foundation Trust, Willerby, UK;Hull York Medical School, Hertford Building, University of Hull, Hull HU6 7RX, UK;Palliative Care Service, Cambridge University Hospitals NHS Trust, Cambridge, UK;Castle Hill Hospital, Hull, UK;Centre for Health Economics, University of York, York, UK;Department of Health Sciences, University of York, York, UK;Department of Sport, Health and Exercise Science, University of Hull, Hull, UK

关键词: Neoplasm;    Cancer;    Dyspnoea;    Breathlessness;    Breathing training;   

Others  :  1224637
DOI  :  10.1186/s12916-015-0453-x

 received in 2015-05-15, accepted in 2015-08-14,  发布年份 2015

【 摘 要 】

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

【 授权许可】

   
2015 Johnson et al.

【 图 表 】

Fig. 1.

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