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

NCT05778708 | Recruiting DMC

• 1 other identifier: UW22-583
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Lung Non-Small Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  28 weeks

Secondary Outcomes (27)

• Change from Baseline Sleep disturbance at 8 weeks

  8 weeks

• Change from Baseline Sleep disturbance at 16 weeks

  16 weeks

• Change from Baseline Sleep disturbance at 28 weeks

  28 weeks

• Change from Baseline Fatigue at 8 weeks

  8 weeks

• Change from Baseline Fatigue at 16 weeks

  16 weeks

Study Arms (3)

Tai-Chi intervention group

EXPERIMENTAL

The standardized 16-form Yang-style Tai-Chi exercise set will be adopted.

Behavioral: Tai-Chi intervention

Aerobic exercise intervention

EXPERIMENTAL

The aerobic exercise class will be designed to cover both aerobic and resistance exercises.

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.

Interventions

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.

Tai-Chi intervention group

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.

Aerobic exercise intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Study Officials

• Chia-Chin Lin, PhD,FAAN,RN

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-Chin Lin, PhD,FAAN,RN

CONTACT

39176633; cclin@hku.hk

Naomi Takemura, BNurs,PhD,RN

CONTACT

39176614; naomitak@connect.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head

Study Record Dates

• First Submitted: February 11, 2023
• First Posted: March 21, 2023
• Study Start: March 13, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)