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Trial Title:
Tai-Chi and Aerobic Exercise to Improve Emotional Symptom Cluster in Late-stage Lung Cancer Patients
NCT ID:
NCT05778708
Condition:
Advanced Lung Non-Small Cell Carcinoma
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Syndrome
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Masking description:
Except for the primary research assistant who will inform the patients of their group
allocation, all researchers on the team will be blinded to patients' group assignment.
Intervention:
Intervention type:
Behavioral
Intervention name:
Tai-Chi intervention
Description:
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.
Arm group label:
Tai-Chi intervention group
Intervention type:
Behavioral
Intervention name:
Aerobic exercise intervention
Description:
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.
Arm group label:
Aerobic exercise intervention
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Queen Mary Hospital
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Start date:
March 13, 2023
Completion date:
October 2026
Lead sponsor:
Agency:
The University of Hong Kong
Agency class:
Other
Collaborator:
Agency:
Queen Mary Hospital, Hong Kong
Agency class:
Other
Source:
The University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05778708
