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NCT Number: NCT05778708

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

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.

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Key information

Conditions

Advanced Lung Non-Small Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital

Hong Kong

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai-Chi intervention

Behavioral

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 intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Change from Baseline Sleep disturbance at 8 weeks

    Time frame: 8 weeks

    Measured by the Pittsburg Sleep Quality Index. The total score ranges from 0-21, with higher scores denoting poorer sleep.

  2. Change from Baseline Sleep disturbance at 16 weeks

    Time frame: 16 weeks

    Measured by the Pittsburg Sleep Quality Index. The total score ranges from 0-21, with higher scores denoting poorer sleep.

  3. Change from Baseline Sleep disturbance at 28 weeks

    Time frame: 28 weeks

    Measured by the Pittsburg Sleep Quality Index. The total score ranges from 0-21, with higher scores denoting poorer sleep.

  4. Change from Baseline Fatigue at 8 weeks

    Time frame: 8 weeks

    Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level.

  5. Change from Baseline Fatigue at 16 weeks

    Time frame: 16 weeks

    Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level.

  6. Change from Baseline Fatigue at 28 weeks

    Time frame: 28 weeks

    Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level.

  7. Change from Baseline Anxiety and depression at 8 weeks

    Time frame: 8 weeks

    Measured by the Hospital Anxiety and Depression Scale. Higher score denotes higher level of anxiety and depression.

  8. Change from Baseline Anxiety and depression at 16 weeks

    Time frame: 16 weeks

    Measured by the Hospital Anxiety and Depression Scale. Higher score denotes higher level of anxiety and depression.

  9. Change from Baseline Anxiety and depression at 28 weeks

    Time frame: 28 weeks

    Measured by the Hospital Anxiety and Depression Scale. Higher score denotes higher level of anxiety and depression.

  10. Change from Baseline Emotion regulation at 8 weeks

    Time frame: 8 weeks

    Measured by the Emotion Regulation Questionnaire. Higher scores indicating greater usage of that strategy.

  11. Change from Baseline Emotion regulation at 16 weeks

    Time frame: 16 weeks

    Measured by the Emotion Regulation Questionnaire. Higher scores indicating greater usage of that strategy.

  12. Change from Baseline Emotion regulation at 28 weeks

    Time frame: 28 weeks

    Measured by the Emotion Regulation Questionnaire. Higher scores indicating greater usage of that strategy.

  13. Change from Baseline Mindfulness at 8 weeks

    Time frame: 8 weeks

    Measured by the Five Facet Mindfulness Questionnaire-Short Form. Higher score denotes higher mindfulness experience.

  14. Change from Baseline Mindfulness at 16 weeks

    Time frame: 16 weeks

    Measured by the Five Facet Mindfulness Questionnaire-Short Form. Higher score denotes higher mindfulness experience.

  15. Change from Baseline Mindfulness at 28 weeks

    Time frame: 28 weeks

    Measured by the Five Facet Mindfulness Questionnaire-Short Form. Higher score denotes higher mindfulness experience.

  16. Change from Baseline Cardiorespiratory fitness at 8 weeks

    Time frame: 8 weeks

    Measured by the six-minute walk test. The distance walked at the end of 6 minutes will be measured in meters.

  17. Change from Baseline Cardiorespiratory fitness at 16 weeks

    Time frame: 16 weeks

    Measured by the six-minute walk test. The distance walked at the end of 6 minutes will be measured in meters.

  18. Change from Baseline Cardiorespiratory fitness at 28 weeks

    Time frame: 28 weeks

    Measured by the six-minute walk test. The distance walked at the end of 6 minutes will be measured in meters.

  19. Change from Baseline agility at 8 weeks

    Time frame: 8 weeks

    Measured by the timed up-and-go test; unit: second.

  20. Change from Baseline agility at 16 weeks

    Time frame: 16 weeks

    Measured by the timed up-and-go test; unit: second.

  21. Change from Baseline agility at 28 weeks

    Time frame: 28 weeks

    Measured by the timed up-and-go test; unit: second.

  22. Change from Baseline strength at 8 weeks

    Time frame: 8 weeks

    Measured by the sit-to-stand test; unit: number of times.

  23. Change from Baseline strength at 16 weeks

    Time frame: 16 weeks

    Measured by the sit-to-stand test; unit: number of times.

  24. Change from Baseline strength at 28 weeks

    Time frame: 28 weeks

    Measured by the sit-to-stand test; unit: number of times.

  25. Change from Baseline balance at 8 weeks

    Time frame: 8 weeks

    Measured by the single-leg standing test; ; unit: second.

  26. Change from Baseline balance at 16 weeks

    Time frame: 16 weeks

    Measured by the single-leg standing test; ; unit: second.

  27. Change from Baseline balance at 28 weeks

    Time frame: 28 weeks

    Measured by the single-leg standing test; ; unit: second.

Study contacts

Contact information is provided by the study sponsor or research team.

Chia-Chin Lin, PhD,FAAN,RN

CONTACT

[email protected]

39176633

Naomi Takemura, BNurs,PhD,RN

CONTACT

[email protected]

39176614

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Queen Mary Hospital, Hong Kong

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2023
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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