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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
318
The standardized 16-form Yang-style Tai-Chi exercise set will be adopted. Group classes will take place in a community center twice a week for 16 weeks, with each class lasting approximately 60 minutes. Classes will be taught by an experienced Tai-Chi master. Patients will be instructed to practice the Tai-Chi exercises at home at least 3 times a week (30 min each time for a total of 90 min). Patients will be provided with a daily exercise log to record their exercise type, frequency, and intensity.
The aerobic exercise class will be designed to cover both aerobic and resistance exercises. Group classes will take place in an exercise center twice a week for 16 weeks, with each class lasting approximately 60 minutes. Each class will be led by a certified exercise specialist. Patients will be provided with a daily exercise log to record their exercise type, frequency, and intensity.
Queen Mary Hospital
Hong Kong, Hong Kong
RECRUITINGChange from Baseline Emotional symptom cluster at 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.
Time frame: 8 weeks
Change from Baseline Emotional symptom cluster at 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.
Time frame: 16 weeks
Change from Baseline Emotional symptom cluster at 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.
Time frame: 28 weeks
Change from Baseline Sleep disturbance at 8 weeks
Measured by the Pittsburg Sleep Quality Index. The total score ranges from 0-21, with higher scores denoting poorer sleep.
Time frame: 8 weeks
Change from Baseline Sleep disturbance at 16 weeks
Measured by the Pittsburg Sleep Quality Index. The total score ranges from 0-21, with higher scores denoting poorer sleep.
Time frame: 16 weeks
Change from Baseline Sleep disturbance at 28 weeks
Measured by the Pittsburg Sleep Quality Index. The total score ranges from 0-21, with higher scores denoting poorer sleep.
Time frame: 28 weeks
Change from Baseline Fatigue at 8 weeks
Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level.
Time frame: 8 weeks
Change from Baseline Fatigue at 16 weeks
Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level.
Time frame: 16 weeks
Change from Baseline Fatigue at 28 weeks
Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level.
Time frame: 28 weeks
Change from Baseline Anxiety and depression at 8 weeks
Measured by the Hospital Anxiety and Depression Scale. Higher score denotes higher level of anxiety and depression.
Time frame: 8 weeks
Change from Baseline Anxiety and depression at 16 weeks
Measured by the Hospital Anxiety and Depression Scale. Higher score denotes higher level of anxiety and depression.
Time frame: 16 weeks
Change from Baseline Anxiety and depression at 28 weeks
Measured by the Hospital Anxiety and Depression Scale. Higher score denotes higher level of anxiety and depression.
Time frame: 28 weeks
Change from Baseline Emotion regulation at 8 weeks
Measured by the Emotion Regulation Questionnaire. Higher scores indicating greater usage of that strategy.
Time frame: 8 weeks
Change from Baseline Emotion regulation at 16 weeks
Measured by the Emotion Regulation Questionnaire. Higher scores indicating greater usage of that strategy.
Time frame: 16 weeks
Change from Baseline Emotion regulation at 28 weeks
Measured by the Emotion Regulation Questionnaire. Higher scores indicating greater usage of that strategy.
Time frame: 28 weeks
Change from Baseline Mindfulness at 8 weeks
Measured by the Five Facet Mindfulness Questionnaire-Short Form. Higher score denotes higher mindfulness experience.
Time frame: 8 weeks
Change from Baseline Mindfulness at 16 weeks
Measured by the Five Facet Mindfulness Questionnaire-Short Form. Higher score denotes higher mindfulness experience.
Time frame: 16 weeks
Change from Baseline Mindfulness at 28 weeks
Measured by the Five Facet Mindfulness Questionnaire-Short Form. Higher score denotes higher mindfulness experience.
Time frame: 28 weeks
Change from Baseline Cardiorespiratory fitness at 8 weeks
Measured by the six-minute walk test. The distance walked at the end of 6 minutes will be measured in meters.
Time frame: 8 weeks
Change from Baseline Cardiorespiratory fitness at 16 weeks
Measured by the six-minute walk test. The distance walked at the end of 6 minutes will be measured in meters.
Time frame: 16 weeks
Change from Baseline Cardiorespiratory fitness at 28 weeks
Measured by the six-minute walk test. The distance walked at the end of 6 minutes will be measured in meters.
Time frame: 28 weeks
Change from Baseline agility at 8 weeks
Measured by the timed up-and-go test; unit: second.
Time frame: 8 weeks
Change from Baseline agility at 16 weeks
Measured by the timed up-and-go test; unit: second.
Time frame: 16 weeks
Change from Baseline agility at 28 weeks
Measured by the timed up-and-go test; unit: second.
Time frame: 28 weeks
Change from Baseline strength at 8 weeks
Measured by the sit-to-stand test; unit: number of times.
Time frame: 8 weeks
Change from Baseline strength at 16 weeks
Measured by the sit-to-stand test; unit: number of times.
Time frame: 16 weeks
Change from Baseline strength at 28 weeks
Measured by the sit-to-stand test; unit: number of times.
Time frame: 28 weeks
Change from Baseline balance at 8 weeks
Measured by the single-leg standing test; ; unit: second.
Time frame: 8 weeks
Change from Baseline balance at 16 weeks
Measured by the single-leg standing test; ; unit: second.
Time frame: 16 weeks
Change from Baseline balance at 28 weeks
Measured by the single-leg standing test; ; unit: second.
Time frame: 28 weeks
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