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Multidisciplinary home-based rehabilitation in inoperable lung cancer: a randomised controlled trial [with consumer summary]
Edbrooke L, Aranda S, Granger CL, McDonald CF, Krishnasamy M, Mileshkin L, Clark RA, Gordon I, Irving L, Denehy L
Thorax 2019 Aug;74(8):787-796
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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).
Reproduced with permission from the BMJ Publishing Group.

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