Background Lung cancer is associated with poor health-related quality of life (HRQoL) and high symptom burden. This trial aimed to assess the efficacy of home-based rehabilitation versus usual care in inoperable lung cancer.
Methods A parallel-group, assessor-blinded, allocation-concealed, randomised controlled trial. Eligible participants were allocated (1:1) to usual care (UC) plus 8 weeks of aerobic and resistance exercise with behaviour change strategies and symptom support (intervention group (IG)) or UC alone. Assessments occurred at baseline, 9 weeks and 6 months. The primary outcome, change in between-group 6 min walk distance (6MWD), was analysed using intention-to-treat (ITT). Subsequent analyses involved modified ITT (mITT) and included participants with at least one follow-up outcome measure. Secondary outcomes included HRQoL and symptoms.
Results Ninety-two participants were recruited. Characteristics of participants (UC=47, IG=45): mean (SD) age 64 (12) years; men 55%; disease stage n (%) III=35 (38) and IV=48 (52); radical treatment 46%. There were no significant between-group differences for the 6MWD (n=92) at 9 weeks (p=0.308) or 6 months (p=0.979). The mITT analyses of 6MWD between-group differences were again non-significant (mean difference (95% CI): 9 weeks: −25.4 m (−64.0 to 13.3), p=0.198 and 6 months: 41.3 m (−26.7 to 109.4), p=0.232). Significant 6-month differences, favouring the IG, were found for HRQoL (Functional Assessment of Cancer Therapy–Lung: 13.0 (3.9 to 22.1), p=0.005) and symptom severity (MD Anderson Symptom Inventory–Lung Cancer: −2.2 (−3.6 to –0.9), p=0.001).
Conclusions Home-based rehabilitation did not improve functional exercise capacity but there were improvements in patient-reported exploratory secondary outcomes measures observed at 6 months.
Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12614001268639).
- non-small cell lung cancer
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Presented at This study was presentated at the European Respiratory Society Congress, 2018.
Contributors LD, SA, CLG, CFM, MK, LM and LI conceived the study and devised the design. IG devised the statistical analysis plan. LE co-ordinated the trial and was responsible for data acquisition. IG and LE undertook the data analyses and interpretation. LE drafted the manuscript. All authors critically reviewed the manuscript and approved the final version prior to submission. LE managed the manuscript submission.
Funding This trial was funded through a National Health and Medical Research project grant (APP1060484). LE is the recipient of a Victorian Government Olivia Newton John Cancer Wellness and Research Centre Supportive Care PhD scholarship, through the Victorian Cancer Agency.
Disclaimer The funders of the trial had no role in trial design, data collection, data analysis, data interpretation or writing of the report.
Competing interests None declared.
Patient consent for publication Obtained.
Ethics approval The Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC/14/PMCC/27).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Data are available upon reasonable request.