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