NCT04826835招募中不适用
A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients: a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Change from baseline 6-minute walking distance from baseline to 3-month post-surgery
研究概览
简要总结
This research study is evaluating a prehabiliation intervention designed to improve postoperative functional capacity (measured by 6-minure walking distance) in individuals undergoing lung resection for cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed of stage I, II, or IIIA Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation
- •Patients scheduled to undergo lung resection surgery at least two weeks from recruitment
- •Patients with a Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 at recruitment
- •Patients with no evidence of recurrent or progressive disease
- •Patients aged 45-80 years
- •Patients able to communicate in Cantonese, Mandarin, or English
- •Patients is absence of any cognitive impairment
- •Patients with a score of 6 minutes walking test (6MWT) ≤ 500 meters at baseline. [rationale: a threshold value of 500 meters preoperative 6MWT predicts a higher risk of postoperative complications and prolonged LOS after lung resection]
- •Engagement in less than 150 minutes of moderate aerobic activity per week in the past 3 months
排除标准
- •Patients who had engaged in at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity per week in the past three months
- •Presence of another concurrent, actively treated malignancy
- •Presence of chronic obstructive pulmonary disease
- •Presence of significant comorbidities that impede ability to engage in exercise, such as congestive heart failure, orthopedic disorders of the lower limbs, respiratory failure, or the need for portable oxygen therapy for activities of daily living
- •Not having a smart device to receive WhatsApp messages
结局指标
主要结局
Change from baseline 6-minute walking distance from baseline to 3-month post-surgery
时间窗: Baseline; 3-month post-surgery
次要结局
- Change from baseline 6-minute walking distance at 1-month post-surgery(Baseline; 1-months post-surgery)
- Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at post-intervention(Baseline; 2 weeks (post-intervention))
- Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 1-month post-surgery(Baseline; 2 weeks (post-intervention); 1-month post-surgery)
- Change from baseline daily step count measured by pedometer at 1-month post-surgery(Baseline; 1-month post-surgery)
- Length of postoperative hospital stay(1-month post-surgery)
- Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 3-months post-surgery(Baseline; 3-month post-surgery)
- Change from baseline international physical activity questionnaire (IPAQ) at 3-month post-surgery(Baseline; 3-month post-surgery)
- Change from baseline daily step count measured by pedometer at post-intervention(Baseline; 2 weeks (post-intervention))
- Postoperative complication(1-month post-surgery)
- Change from baseline international physical activity questionnaire (IPAQ) at post-intervention(Baseline; 2 weeks (post-intervention))
- Change from baseline international physical activity questionnaire (IPAQ) at 1-month post-surgery(Baseline; 1-month post-surgery)
- Financial toxicity (COmprehensive Score for financial Toxicity, COST questionnaire)(Baseline; 3-month post-surgery)
- Return to work (investigator-designed questionnaire)(3-month post-surgery)
- Health-related quality of life for the cost-effectiveness analysis (EuroQol- 5 Dimension, EQ-5D-5L)(Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery)
- Physical activity self-efficacy (9-item Self-Efficacy for Exercise, SEE)(Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery)
- Change from baseline 6-minute walking distance at post-intervention(Baseline; 2 weeks (post-intervention))
- Change from baseline daily step count measured by pedometer at 3-month post-surgery(Baseline; 3-month post-surgery)
- Health-related quality of life for the cost-effectiveness analysis (EuroQol-Visual Analog Score, EQ-VAS)(Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery)
研究者
Professor Chia-Chin Lin
Professor and Head
The University of Hong Kong
研究点 (1)
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