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

May 9, 2023 updated by: Professor Chia-Chin Lin, The University of Hong Kong
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
318

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chia-Chin Lin, PhD,FAAN,RN
  • Phone Number: 39176633
  • Email: cclin@hku.hk

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tai-Chi intervention group
The standardized 16-form Yang-style Tai-Chi exercise set will be adopted.
Behavioral: Tai-Chi intervention
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.
Experimental: Aerobic exercise intervention
The aerobic exercise class will be designed to cover both aerobic and resistance exercises.
Behavioral: Aerobic exercise intervention
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.
No Intervention: Self-management control group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
16 weeks
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.
28 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
16 weeks
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.
28 weeks
Change from Baseline Fatigue at 8 weeks
Time Frame: 8 weeks
Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level.
8 weeks
Change from Baseline Fatigue at 16 weeks
Time Frame: 16 weeks
Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level.
16 weeks
Change from Baseline Fatigue at 28 weeks
Time Frame: 28 weeks
Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level.
28 weeks
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 weeks
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.
16 weeks
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.
28 weeks
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.
8 weeks
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.
16 weeks
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.
28 weeks
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.
8 weeks
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.
16 weeks
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.
28 weeks
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.
8 weeks
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.
16 weeks
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.
28 weeks
Change from Baseline agility at 8 weeks
Time Frame: 8 weeks
Measured by the timed up-and-go test; unit: second.
8 weeks
Change from Baseline agility at 16 weeks
Time Frame: 16 weeks
Measured by the timed up-and-go test; unit: second.
16 weeks
Change from Baseline agility at 28 weeks
Time Frame: 28 weeks
Measured by the timed up-and-go test; unit: second.
28 weeks
Change from Baseline strength at 8 weeks
Time Frame: 8 weeks
Measured by the sit-to-stand test; unit: number of times.
8 weeks
Change from Baseline strength at 16 weeks
Time Frame: 16 weeks
Measured by the sit-to-stand test; unit: number of times.
16 weeks
Change from Baseline strength at 28 weeks
Time Frame: 28 weeks
Measured by the sit-to-stand test; unit: number of times.
28 weeks
Change from Baseline balance at 8 weeks
Time Frame: 8 weeks
Measured by the single-leg standing test; ; unit: second.
8 weeks
Change from Baseline balance at 16 weeks
Time Frame: 16 weeks
Measured by the single-leg standing test; ; unit: second.
16 weeks
Change from Baseline balance at 28 weeks
Time Frame: 28 weeks
Measured by the single-leg standing test; ; unit: second.
28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Queen Mary Hospital, Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chia-Chin Lin, PhD,FAAN,RN, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UW22-583

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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