Advanced Lung Non-Small Cell CarcinomaNCT05778708
Tai-Chi and Aerobic Exercise to Improve Emotional Symptom Cluster in Late-stage Lung Cancer Patients
A study testing Tai-Chi intervention and Aerobic exercise intervention in people with Advanced Lung Non-Small Cell Carcinoma, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Non-Small Cell Carcinoma
- What is being tested?
- Tai-Chi intervention and Aerobic exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 Mar 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Advanced Lung Non-Small Cell Carcinoma
- Being tested
- Tai-Chi intervention, Aerobic exercise intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai-Chi interventionBehavioural
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.
Aerobic exercise interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tai-Chi intervention group | Experimental | The standardized 16-form Yang-style Tai-Chi exercise set will be adopted. Receives: Behavioral: Tai-Chi intervention |
| Aerobic exercise intervention | Experimental | The aerobic exercise class will be designed to cover both aerobic and resistance exercises. Receives: Behavioral: Aerobic exercise intervention |
| Self-management control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 28 weeks
Secondary outcomes (27)
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.
Measured: 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.
Measured: 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.
Measured: 28 weeks
Change from Baseline Fatigue at 8 weeks
Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level.
Measured: 8 weeks
Change from Baseline Fatigue at 16 weeks
Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level.
Measured: 16 weeks
Change from Baseline Fatigue at 28 weeks
Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 weeks
Change from Baseline Emotion regulation at 8 weeks
Measured by the Emotion Regulation Questionnaire. Higher scores indicating greater usage of that strategy.
Measured: 8 weeks
Change from Baseline Emotion regulation at 16 weeks
Measured by the Emotion Regulation Questionnaire. Higher scores indicating greater usage of that strategy.
Measured: 16 weeks
Change from Baseline Emotion regulation at 28 weeks
Measured by the Emotion Regulation Questionnaire. Higher scores indicating greater usage of that strategy.
Measured: 28 weeks
Change from Baseline Mindfulness at 8 weeks
Measured by the Five Facet Mindfulness Questionnaire-Short Form. Higher score denotes higher mindfulness experience.
Measured: 8 weeks
Change from Baseline Mindfulness at 16 weeks
Measured by the Five Facet Mindfulness Questionnaire-Short Form. Higher score denotes higher mindfulness experience.
Measured: 16 weeks
Change from Baseline Mindfulness at 28 weeks
Measured by the Five Facet Mindfulness Questionnaire-Short Form. Higher score denotes higher mindfulness experience.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 weeks
Change from Baseline agility at 8 weeks
Measured by the timed up-and-go test; unit: second.
Measured: 8 weeks
Change from Baseline agility at 16 weeks
Measured by the timed up-and-go test; unit: second.
Measured: 16 weeks
Change from Baseline agility at 28 weeks
Measured by the timed up-and-go test; unit: second.
Measured: 28 weeks
Change from Baseline strength at 8 weeks
Measured by the sit-to-stand test; unit: number of times.
Measured: 8 weeks
Change from Baseline strength at 16 weeks
Measured by the sit-to-stand test; unit: number of times.
Measured: 16 weeks
Change from Baseline strength at 28 weeks
Measured by the sit-to-stand test; unit: number of times.
Measured: 28 weeks
Change from Baseline balance at 8 weeks
Measured by the single-leg standing test; ; unit: second.
Measured: 8 weeks
Change from Baseline balance at 16 weeks
Measured by the single-leg standing test; ; unit: second.
Measured: 16 weeks
Change from Baseline balance at 28 weeks
Measured by the single-leg standing test; ; unit: second.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start13 Mar 2023
- Primary completionFeb 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Responsible party
- Principal investigator, Professor Chia-Chin Lin, The University of Hong Kong
- Investigators
- Chia-Chin Lin, PhD,FAAN,RN, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778708
- Sponsor's protocol ID
- UW22-583
- Status last verified
- May 2023
- First submitted
- 11 Feb 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai-Chi and Aerobic Exercise to Improve Emotional Symptom Cluster in Late-stage Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT05778708
- Acronym / sponsor ID
- UW22-583
- Conditions
- Advanced Lung Non-Small Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tai-Chi intervention group | Experimental | Behavioral: Tai-Chi interventionThe standardized 16-form Yang-style Tai-Chi exercise set will be adopted. |
| Aerobic exercise intervention | Experimental | Behavioral: Aerobic exercise interventionThe aerobic exercise class will be designed to cover both aerobic and resistance exercises. |
| Self-management control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai-Chi interventionThe 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. | Behavioural | Tai-Chi intervention group |
| Aerobic exercise interventionThe 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. | Behavioural | Aerobic exercise intervention |
Primary outcome
Change from Baseline Emotional symptom cluster at 8 weeks
Time frame: 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
Time frame: 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
Time frame: 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.
27 secondary outcomes
Change from Baseline Sleep disturbance at 8 weeks
Time frame: 8 weeks
Change from Baseline Sleep disturbance at 16 weeks
Time frame: 16 weeks
Change from Baseline Sleep disturbance at 28 weeks
Time frame: 28 weeks
Change from Baseline Fatigue at 8 weeks
Time frame: 8 weeks
Change from Baseline Fatigue at 16 weeks
Time frame: 16 weeks
Change from Baseline Fatigue at 28 weeks
Time frame: 28 weeks
Change from Baseline Anxiety and depression at 8 weeks
Time frame: 8 weeks
Change from Baseline Anxiety and depression at 16 weeks
Time frame: 16 weeks
Change from Baseline Anxiety and depression at 28 weeks
Time frame: 28 weeks
Change from Baseline Emotion regulation at 8 weeks
Time frame: 8 weeks
Change from Baseline Emotion regulation at 16 weeks
Time frame: 16 weeks
Change from Baseline Emotion regulation at 28 weeks
Time frame: 28 weeks
Change from Baseline Mindfulness at 8 weeks
Time frame: 8 weeks
Change from Baseline Mindfulness at 16 weeks
Time frame: 16 weeks
Change from Baseline Mindfulness at 28 weeks
Time frame: 28 weeks
Change from Baseline Cardiorespiratory fitness at 8 weeks
Time frame: 8 weeks
Change from Baseline Cardiorespiratory fitness at 16 weeks
Time frame: 16 weeks
Change from Baseline Cardiorespiratory fitness at 28 weeks
Time frame: 28 weeks
Change from Baseline agility at 8 weeks
Time frame: 8 weeks
Change from Baseline agility at 16 weeks
Time frame: 16 weeks
Change from Baseline agility at 28 weeks
Time frame: 28 weeks
Change from Baseline strength at 8 weeks
Time frame: 8 weeks
Change from Baseline strength at 16 weeks
Time frame: 16 weeks
Change from Baseline strength at 28 weeks
Time frame: 28 weeks
Change from Baseline balance at 8 weeks
Time frame: 8 weeks
Change from Baseline balance at 16 weeks
Time frame: 16 weeks
Change from Baseline balance at 28 weeks
Time frame: 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Chin Lin, PhD,FAAN,RN principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai-Chi intervention and Aerobic exercise intervention in people with Advanced Lung Non-Small Cell Carcinoma, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Chin Lin, PhD,FAAN,RN (39176633, cclin@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Emotional symptom cluster at 8 weeks (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.