Tai-Chi and Aerobic Exercise to Improve Emotional Symptom Cluster in Late-stage Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- Change from Baseline Emotional symptom cluster at 16 weeks
研究概览
简要总结
The goal of this randomized controlled trial is to investigate the effects of Tai-Chi and aerobic exercise on the emotional symptom cluster, and the underlying mechanism of that cluster, in late-stage lung cancer patients. Participants will be randomized into one of three groups: 1) Tai-Chi group, 2) aerobic exercise group, or 3) self-management control group. Both the Tai-Chi and aerobic exercise groups will attend twice-weekly group classes for 16 weeks (32 total contact hours). The self-management control group will receive written information regarding the recommended level of physical activity.
详细描述
Late-stage lung cancer patients (n = 318) meeting the inclusion criteria will be recruited and randomized into one of three groups: 1) Tai-Chi group, 2) aerobic exercise group, or 3) self-management control group. Both the Tai-Chi and aerobic exercise groups will attend twice-weekly group classes for 16 weeks (32 total contact hours). The self-management control group will receive written information regarding the recommended level of physical activity. To evaluate the effectiveness of Tai-Chi and aerobic exercise in alleviating the emotional symptom cluster (primary outcome) and individual symptoms (sleep disturbance, anxiety, depression, fatigue), outcome measures will be conducted at baseline, 8 weeks (mid-point assessment), 16 weeks (post-intervention), and 28 weeks (12-weeks post-intervention). A linear mixed-effects model will be used to study the between-group differences in outcomes. In addition, emotion regulation, mindfulness, and cardiorespiratory fitness will be evaluated at each data collection point, and structural equation modeling will be used for subsequent mediation analysis to determine their mediating role in outcome changes. Qualitative interviews will be conducted to understand patients' experience and evaluation of the interventions.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Except for the primary research assistant who will inform the patients of their group allocation, all researchers on the team will be blinded to patients' group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with stage IIIB or IV non-small cell lung cancer confirmed by pathology, with no other cancer diagnosis within the previous year;
- •a current Eastern Cooperative Oncology Group Performance Status of 0-2;
- •experience of sleep disturbance, anxiety, depression, and fatigue in the past week (rating of 1 or more on a 0-10 numeric rating scale [NRS] for each symptom);
- •able to communicate in Cantonese, Mandarin, or English;
- •conscious and alert
排除标准
- •suffering from a condition that hinders exercise performance (e.g., active neurological disorder, recent heart attack);
- •currently participating in any other exercise or mind-body classes; or 3) performing regular exercises, defined as at least 150 minutes of moderate-intensity exercise weekly
结局指标
主要结局
Change from Baseline Emotional symptom cluster at 16 weeks
时间窗: 16 weeks
NRSs for assessing each symptom of sleep disturbance, anxiety, depression, and fatigue over the past 7 days will be used to measure emotional symptom cluster severity. Higher score indicates more severe symptoms.
Change from Baseline Emotional symptom cluster at 8 weeks
时间窗: 8 weeks
NRSs for assessing each symptom of sleep disturbance, anxiety, depression, and fatigue over the past 7 days will be used to measure emotional symptom cluster severity. Higher score indicates more severe symptoms.
Change from Baseline Emotional symptom cluster at 28 weeks
时间窗: 28 weeks
NRSs for assessing each symptom of sleep disturbance, anxiety, depression, and fatigue over the past 7 days will be used to measure emotional symptom cluster severity. Higher score indicates more severe symptoms.
次要结局
- Change from Baseline Sleep disturbance at 16 weeks(16 weeks)
- Change from Baseline Fatigue at 16 weeks(16 weeks)
- Change from Baseline Anxiety and depression at 8 weeks(8 weeks)
- Change from Baseline Sleep disturbance at 8 weeks(8 weeks)
- Change from Baseline Fatigue at 8 weeks(8 weeks)
- Change from Baseline Fatigue at 28 weeks(28 weeks)
- Change from Baseline Anxiety and depression at 16 weeks(16 weeks)
- Change from Baseline Anxiety and depression at 28 weeks(28 weeks)
- Change from Baseline Emotion regulation at 8 weeks(8 weeks)
- Change from Baseline Emotion regulation at 28 weeks(28 weeks)
- Change from Baseline Mindfulness at 28 weeks(28 weeks)
- Change from Baseline Emotion regulation at 16 weeks(16 weeks)
- Change from Baseline Sleep disturbance at 28 weeks(28 weeks)
- Change from Baseline agility at 16 weeks(16 weeks)
- Change from Baseline Mindfulness at 8 weeks(8 weeks)
- Change from Baseline strength at 16 weeks(16 weeks)
- Change from Baseline Mindfulness at 16 weeks(16 weeks)
- Change from Baseline Cardiorespiratory fitness at 28 weeks(28 weeks)
- Change from Baseline agility at 28 weeks(28 weeks)
- Change from Baseline strength at 8 weeks(8 weeks)
- Change from Baseline balance at 16 weeks(16 weeks)
- Change from Baseline Cardiorespiratory fitness at 8 weeks(8 weeks)
- Change from Baseline agility at 8 weeks(8 weeks)
- Change from Baseline Cardiorespiratory fitness at 16 weeks(16 weeks)
- Change from Baseline strength at 28 weeks(28 weeks)
- Change from Baseline balance at 8 weeks(8 weeks)
- Change from Baseline balance at 28 weeks(28 weeks)
研究者
Professor Chia-Chin Lin
Professor and Head
The University of Hong Kong