Centre for Medical Psychology and Evidence-Based Decision-Making, University of Sydney, Sydney, Australia.
Mel & Enid Zuckerman College of Public Health, University of Arizona, Tucson, USA.
Ann Oncol. 2017 Aug 1;28(8):1889-1897. doi: 10.1093/annonc/mdx205.
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.
Participants with advanced lung cancer, Eastern Cooperative Oncology Group performance status (PS) ≤2, >6 months life expectancy, and ability to complete six-min walk test, were stratified (disease stage, PS 0-1 versus 2, centre) and randomized (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 [Functional Assessment of Cancer Therapy-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.
We recruited 112 patients: 56 (50.4%) were randomized to EX, 55(49.5%) to UC; 1 ineligible. Male 55%; median age 64 years (34-80); 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, 5.8, P = 0.62). There were no significant differences in QOL, symptoms, physical or functional status, or survival.
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.
Australian New Zealand Clinical Trials Registry No. ACTRN12609000971235.
身体活动（PA）可改善癌症幸存者的疲劳和生活质量（QOL）。我们的目的是评估为期 2 个月的 PA 干预是否可改善晚期肺癌患者的疲劳和 QOL。
纳入 ECOG 表现状态（PS）≤2、预期寿命>6 个月且能够完成 6 分钟步行试验的晚期肺癌患者，按疾病分期（PS 0-1 与 2、中心）和开放性标签研究（1:1）分层并随机分配至常规护理（UC）（营养和 PA 教育材料）或实验组（EX）：UC 加 2 个月的监督性每周 PA 和行为改变课程。在基线、2、4 和 6 个月时进行评估。主要终点是 2 个月时的疲劳[癌症治疗功能评估-疲劳（FACT-F）问卷]。该研究旨在检测平均 FACT-F 亚量表评分差异 6 分。分析采用意向治疗线性混合模型。
共纳入 112 例患者：56 例（50.4%）随机分配至 EX 组，55 例（49.5%）至 UC 组；1 例患者不合格。男性占 55%；中位年龄 64 岁（34-80）；106 例（96%）为非小细胞肺癌；106 例（95.5%）为 IV 期。在 2、4 和 6 个月时，分别有 90、73 和 62 例患者接受评估，两组间无失访差异。两组间的疲劳无显著差异：EX 组 2 个月时的平均评分 37.5，UC 组 36.4（差异 1.2，95%CI-3.5, 5.8，P=0.62）。QOL、症状、体力或功能状态或生存率均无显著差异。
尽管干预措施的依从性良好，但与对照组相比，实验组的 PA 增加不足，疲劳或 QOL 未见改善。
澳大利亚新西兰临床试验注册中心编号 ACTRN12609000971235。
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