BACKGROUND: Physical activity (PA) improves fatigue and quality-of-life (QOL) in cancer survivors. Our aim was to assess whether a 2-month PA intervention improves fatigue and QOL for people with advanced lung cancer. METHODS: Participants with advanced lung cancer, Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2, > 6 months life expectancy, and ability to complete 6-Minute Walk Test, were stratified (disease stage, PS 0 to 1 versus 2, centre) and randomised (1:1) in an open-label study to usual care (UC) (nutrition and PA education materials) or experimental intervention (EX): UC plus 2-month supervised weekly PA and behaviour change sessions. Assessments occurred at baseline, 2, 4, and 6-months. The primary endpoint was fatigue (FACT-F questionnaire) at 2-months. The study was designed to detect a difference in mean FACT-F subscale score of 6. Analysis was intention-to-treat using linear mixed models. RESULTS: We recruited 112 patients: 56 (50.4%) were randomised to EX, 55 (49.5%) to UC; 1 ineligible. Male 55%; median age 64 years (34 to 80); 106 (96%) non-small cell lung cancer; 106 (95.5%) stage IV. At 2, 4 and 6-months, 90, 73 and 62 participants were assessed respectively, with no difference in attrition between groups. There were no significant differences in fatigue between the groups at 2, 4 or 6-months: mean scores at 2 months EX 37.5, UC 36.4 (difference 1.2, 95%CI -3.5 to 5.8, p = 0.62). There were no significant differences in QOL, symptoms, physical or functional status, or survival. CONCLUSIONS: Adherence to the intervention was good but the intervention group did not increase their PA enough compared to the control group, and no difference was seen in fatigue or QOL. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry number ACTRN12609000971235.
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