Tai-Chi and Aerobic Exercise to Improve Emotional Symptom Cluster in Late-stage Lung Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Tai-Chi and Aerobic Exercise to Improve Emotional Symptom Cluster in Late-stage Lung Cancer Patients

Conditions
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Advanced Lung Non-Small Cell Carcinoma

Intervention / Treatment
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* Behavioral: Tai-Chi intervention
* Behavioral: Aerobic exercise intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai-Chi intervention group<br>The standardized 16-form Yang-style Tai-Chi exercise set will be adopted. | Behavioral: Tai-Chi intervention<br>* 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.<br>|
| Experimental: Aerobic exercise intervention<br>The aerobic exercise class will be designed to cover both aerobic and resistance exercises. | Behavioral: Aerobic exercise intervention<br>* 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.<br>|
| No Intervention: Self-management control group<br>Patients in this group will receive written information regarding the recommended levels of exercise (i.e., at least 150 min of moderate-intensity or 75 min of vigorous-intensity aerobic exercise every week) that they can perform at home (self-management) while continuing to receive their standard treatment. They will also be provided with a daily exercise log to record their exercise type, frequency, and intensity. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change 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. | 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. | 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. | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 28 weeks | 
| Change from Baseline Fatigue at 8 weeks | Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level. | 8 weeks | 
| Change from Baseline Fatigue at 16 weeks | Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level. | 16 weeks | 
| Change from Baseline Fatigue at 28 weeks | Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level. | 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. | 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. | 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. | 28 weeks | 
| Change from Baseline Emotion regulation at 8 weeks | Measured by the Emotion Regulation Questionnaire. Higher scores indicating greater usage of that strategy. | 8 weeks | 
| Change from Baseline Emotion regulation at 16 weeks | Measured by the Emotion Regulation Questionnaire. Higher scores indicating greater usage of that strategy. | 16 weeks | 
| Change from Baseline Emotion regulation at 28 weeks | Measured by the Emotion Regulation Questionnaire. Higher scores indicating greater usage of that strategy. | 28 weeks | 
| Change from Baseline Mindfulness at 8 weeks | Measured by the Five Facet Mindfulness Questionnaire-Short Form. Higher score denotes higher mindfulness experience. | 8 weeks | 
| Change from Baseline Mindfulness at 16 weeks | Measured by the Five Facet Mindfulness Questionnaire-Short Form. Higher score denotes higher mindfulness experience. | 16 weeks | 
| Change from Baseline Mindfulness at 28 weeks | Measured by the Five Facet Mindfulness Questionnaire-Short Form. Higher score denotes higher mindfulness experience. | 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. | 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. | 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. | 28 weeks | 
| Change from Baseline agility at 8 weeks | Measured by the timed up-and-go test; unit: second. | 8 weeks | 
| Change from Baseline agility at 16 weeks | Measured by the timed up-and-go test; unit: second. | 16 weeks | 
| Change from Baseline agility at 28 weeks | Measured by the timed up-and-go test; unit: second. | 28 weeks | 
| Change from Baseline strength at 8 weeks | Measured by the sit-to-stand test; unit: number of times. | 8 weeks | 
| Change from Baseline strength at 16 weeks | Measured by the sit-to-stand test; unit: number of times. | 16 weeks | 
| Change from Baseline strength at 28 weeks | Measured by the sit-to-stand test; unit: number of times. | 28 weeks | 
| Change from Baseline balance at 8 weeks | Measured by the single-leg standing test; ; unit: second. | 8 weeks | 
| Change from Baseline balance at 16 weeks | Measured by the single-leg standing test; ; unit: second. | 16 weeks | 
| Change from Baseline balance at 28 weeks | Measured by the single-leg standing test; ; unit: second. | 28 weeks |