54 Background: About 90% of patients with lung cancer experience dyspnea. Breathing training is helpful, but multiple sessions may be onerous.
METHODS
UK multisite phase 3 RCT, comparing three weekly sessions of breathing training to a single session for refractory dyspnea due to intrathoracic cancer.
PRIMARY OUTCOME
self-report "worst" dyspnea/24 hours, (0-10 numerical rating scale [NRS], 0=none; 10=worst imaginable).
SECONDARY OUTCOMES
"average", distress due to dyspnea (NRS); quality of life (QoL) (CRQ-SAS; EQ-5D); health service utilisation. Primary analysis point: 4 weeks for dyspnea/QoL. An economic analysis addressed cost-effectiveness from the perspective of UK National Health Service (NHS) and personal social services in a budget constrained system; costs at NHS 2012/13 prices.
PRIMARY OUTCOME
Quality Adjusted Life Year (QALY) over 8 weeks.
RESULTS
156 were randomized: age 69 (SD 9.4); 40% women; Karnofsky performance status 71% (SD 9.5); 133 primary lung. "Worst" score improved, 6.8 (SD1.9) at baseline to 5.8 (SD 2.4) at week 4. There was no detected difference in area under curve (AUC): three 22.9(SD 7.1) versus single 22.7(SD 7.1); P = 0.83; 95% difference CI (-2.3, 2.9), or for AUC "average", or CRQ-SAS. AUC "distress" was less in the single group (16.2 versus 12.3; P = 0.01). Using complete cases, three sessions were associated with a QALY reduction of 0.006 (95% CI -0.18 to +0.006) over 8 weeks and 0.008 (95% CI -0.022 to 0.006) with multiple imputation, and showed increase in costs when adjusted for baseline health related QoL (Mean increased cost £37; 95% CI -506 to +581).
CONCLUSIONS
Three sessions conferred no benefits over one and had a worse QALY profile. Though statistically insignificant, a single session seems to be a cost-effective way to provide breathing training, minimising the burden of healthcare visits.
CLINICAL TRIAL INFORMATION
ISRCTN49387307.