About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

318 Participants

are divided into 3 treatment groups

Group A: Tai-Chi intervention groupExperimental treatment 1 intervention

Group B: Aerobic exercise interventionExperimental treatment 1 intervention

Group C: Self-management control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame

8 weeks

2

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

3

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

Secondary outcomes

1

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

2

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

3

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

4

Change from Baseline Fatigue at 8 weeks

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

Time frame

8 weeks

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts