Tai-Chi and Aerobic Exercise to Improve Emotional Symptom Cluster in Late-stage Lung Cancer Patients
- Conditions
- Advanced Lung Non-Small Cell Carcinoma
- Interventions
- Behavioral: Tai-Chi interventionBehavioral: Aerobic exercise intervention
- Registration Number
- NCT05778708
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 318
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tai-Chi intervention group Tai-Chi intervention The standardized 16-form Yang-style Tai-Chi exercise set will be adopted. Aerobic exercise intervention Aerobic exercise intervention The aerobic exercise class will be designed to cover both aerobic and resistance exercises.
- Primary Outcome Measures
Name Time Method Change from Baseline Emotional symptom cluster at 8 weeks 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 16 weeks 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 28 weeks 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline Fatigue at 16 weeks 16 weeks Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level.
Change from Baseline Anxiety and depression at 8 weeks 8 weeks Measured by the Hospital Anxiety and Depression Scale. Higher score denotes higher level of anxiety and depression.
Change from Baseline Sleep disturbance at 16 weeks 16 weeks Measured by the Pittsburg Sleep Quality Index. The total score ranges from 0-21, with higher scores denoting poorer sleep.
Change from Baseline Sleep disturbance at 8 weeks 8 weeks Measured by the Pittsburg Sleep Quality Index. The total score ranges from 0-21, with higher scores denoting poorer sleep.
Change from Baseline Fatigue at 8 weeks 8 weeks Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level.
Change from Baseline Fatigue at 28 weeks 28 weeks Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level.
Change from Baseline Anxiety and depression at 16 weeks 16 weeks Measured by the Hospital Anxiety and Depression Scale. Higher score denotes higher level of anxiety and depression.
Change from Baseline Anxiety and depression at 28 weeks 28 weeks Measured by the Hospital Anxiety and Depression Scale. Higher score denotes higher level of anxiety and depression.
Change from Baseline Emotion regulation at 8 weeks 8 weeks Measured by the Emotion Regulation Questionnaire. Higher scores indicating greater usage of that strategy.
Change from Baseline Emotion regulation at 28 weeks 28 weeks Measured by the Emotion Regulation Questionnaire. Higher scores indicating greater usage of that strategy.
Change from Baseline Mindfulness at 28 weeks 28 weeks Measured by the Five Facet Mindfulness Questionnaire-Short Form. Higher score denotes higher mindfulness experience.
Change from Baseline Sleep disturbance at 28 weeks 28 weeks Measured by the Pittsburg Sleep Quality Index. The total score ranges from 0-21, with higher scores denoting poorer sleep.
Change from Baseline Emotion regulation at 16 weeks 16 weeks Measured by the Emotion Regulation Questionnaire. Higher scores indicating greater usage of that strategy.
Change from Baseline agility at 16 weeks 16 weeks Measured by the timed up-and-go test; unit: second.
Change from Baseline Mindfulness at 8 weeks 8 weeks Measured by the Five Facet Mindfulness Questionnaire-Short Form. Higher score denotes higher mindfulness experience.
Change from Baseline strength at 16 weeks 16 weeks Measured by the sit-to-stand test; unit: number of times.
Change from Baseline Mindfulness at 16 weeks 16 weeks Measured by the Five Facet Mindfulness Questionnaire-Short Form. Higher score denotes higher mindfulness experience.
Change from Baseline Cardiorespiratory fitness at 28 weeks 28 weeks Measured by the six-minute walk test. The distance walked at the end of 6 minutes will be measured in meters.
Change from Baseline agility at 28 weeks 28 weeks Measured by the timed up-and-go test; unit: second.
Change from Baseline strength at 8 weeks 8 weeks Measured by the sit-to-stand test; unit: number of times.
Change from Baseline balance at 16 weeks 16 weeks Measured by the single-leg standing test; ; unit: second.
Change from Baseline Cardiorespiratory fitness at 8 weeks 8 weeks Measured by the six-minute walk test. The distance walked at the end of 6 minutes will be measured in meters.
Change from Baseline agility at 8 weeks 8 weeks Measured by the timed up-and-go test; unit: second.
Change from Baseline Cardiorespiratory fitness at 16 weeks 16 weeks Measured by the six-minute walk test. The distance walked at the end of 6 minutes will be measured in meters.
Change from Baseline strength at 28 weeks 28 weeks Measured by the sit-to-stand test; unit: number of times.
Change from Baseline balance at 8 weeks 8 weeks Measured by the single-leg standing test; ; unit: second.
Change from Baseline balance at 28 weeks 28 weeks Measured by the single-leg standing test; ; unit: second.
Trial Locations
- Locations (1)
Queen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong