Effect of Qigong on the Symptom Clusters of Dyspnea, Fatigue, and Anxiety.

June 26, 2018 updated by: VU VAN DAU, Nam Dinh University of Nursing
Effects of Qigong on symptom clusters of dyspnea, fatigue, and anxiety in Vietnamese lung cancer patients: A randomized control trial

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Patients with lung cancer experience a variety of symptoms. The number of symptoms ranged from 7.8 to 13.2, and most of them were at a moderate level of severity. Dyspnea, fatigue, and anxiety arose as the most problematic symptoms of lung cancer. Non-pharmacological approaches to manage of symptom among lung cancer patients showed either no or mild effects. Qigong is hypothesized to alleviate these adverse outcomes; however, all trial analyzed on a single symptom, and not lung cancer patients, and there have not been many well-designed randomized control trials. The objectives of this study are following: 1) to assess the effect of Qigong on managing dypsnea, fatigue, and anxiety (as a cluster) in lung cancer patients; 2) to explore the effect of Qigong on cough another common symptom linked with dyspnea, fatigue as a cluster and quality of life (QOL) in lung cancer patients.

Methods: 156 subjects with lung cancer (stage I - IV) will be randomized to either the Qigong group or the wait-list control group. Participants in the Qigong group will conduct Qigong practice 5 times per week for 6 weeks, and participants in the control group will receive usual care. The primary outcome (dypsnea, fatigue, and anxiety), secondary outcomes (cough and QOL) will be assessed at baseline, post-intervention, and post 6-weeks of follow-up.

Discussion: This study will be the first randomized trial to investigate the effectiveness of Qigong for management symptom cluster in lung cancer patients. The finding of this study will help to establish the optimal approach for the care of lung cancer patients.

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • 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 Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic University

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed of lung cancer [Non-small cell lung cancer (NSCLC) or Small cell lung cancer (SCLC)];
  • Patients with Stage I - III NSCLC or SCLC and have completed treatment with chemotherapy and/or radiotherapy for a minimum of 4 weeks prior to commencing the study;
  • Medically fit to participate in general well-being and activities of daily life, as two or smaller on a 0 - to 5-point numeric rating scale at the time of recruitment, as determined by The Eastern Cooperative Oncology Group (ECOG) score;
  • With no evidence of recurrence or occurrence of other cancers; and
  • Patients report all three symptoms (dyspnea, fatigue, and anxiety) in the previous week and ranked the severity of at least two of the three symptoms as 3 or more on a 0 - to 10-point numeric rating scale at the time of recruitment, as determined by dyspnea, fatigue, and anxiety intensity rating scale

Exclusion Criteria:

  • Clinically diagnosed with major psychiatric illness;
  • Presenting with criteria associated with risk during physical activity: severe cachexia; frequent dizziness; bone pain; or severe nausea;
  • Having had past or current regular experience with mind-body practices that blend movement with meditative practices, such as Yoga, Tai Chi, or Qigong;
  • Life expectancy of < 6 months (as determined by their physicians).
  • Visual problems or deafness

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primary aim
The primary aim of this study is to assess the effect of Qigong on managing dyspnea, fatigue, and anxiety (as a cluster) in lung cancer patients.
Behavioral: Qigong
Qigong has long been regarded as a form of "mind-body" intervention in Traditional Chinese Medicine (TCM), which simultaneously exercises the "mind" and the "body" for treating many chronic diseases and promoting wellness. About a hundred million people are currently practicing Qigong in China. Qigong is now regarded as a form of self-practise mind-body exercise and recently relevant to sports activity, which is officially known as "Health Qigong". It is different from "Medical Qigong" which involves a TCM practitioner to emit "Qi" to heal the patients.
Other Names:
  • Chi Kung
Experimental: Secondary aim
The secondary aim of this study is exploring the effect of Qigong on cough which is another common symptom linked with dyspnea, fatigue, and anxiety as a cluster, and QOL in lung cancer patients.
Behavioral: Qigong
Qigong has long been regarded as a form of "mind-body" intervention in Traditional Chinese Medicine (TCM), which simultaneously exercises the "mind" and the "body" for treating many chronic diseases and promoting wellness. About a hundred million people are currently practicing Qigong in China. Qigong is now regarded as a form of self-practise mind-body exercise and recently relevant to sports activity, which is officially known as "Health Qigong". It is different from "Medical Qigong" which involves a TCM practitioner to emit "Qi" to heal the patients.
Other Names:
  • Chi Kung

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A cluster symptom of dyspnea, fatigue, and anxiety in lung cancer patients.
Time Frame: 12 weeks
  • Dyspnea is described as "an uncomfortable awareness of breathing" (DiSalvo, Joyce, Tyson, Culkin, & Mackay, 2008). Cancer Dyspnoea Scale will be used to measure dypsnea in this study.
  • Fatigue is defined as "a subjective feeling of tiredness, weakness or lack of energy" (Radbruch et al., 2008). Functional Assessment of Cancer Therapy-Fatigue (FACT-F) (Yellen et al., 1997) will be used to measure fatigue in this study.
  • Anxiety is defined as "The apprehensive anticipation of future danger or misfortune accompanied by a feeling of dysphoria or somatic symptoms of tension" (American Psychiatric Association, 2005). The Anxiety subscale of the Depression, Anxiety, and Stress Scale 21 (DASS-21) (Sharp et al., 2013) will be used to measure anxiety in this study.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cough
Time Frame: 12 weeks
Cough is "a forced expulsive manoeuvre, usually against a closed glottis and which is associated with a characteristic sound" (McGarvey & Morice, 2006; Pavord & Chung, 2008). Manchester Cough in Lung Cancer Scale (MCLCS) (Molassiotis et al., 2012) will be used to measure cough in this study.
12 weeks
Quality of Life
Time Frame: 12 weeks
The World Health Organization (WHO) defined health as "a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity". European Organization for Research and Treatment of Cancer -Quality of life questionnaire - Core and Lung module (Fayers et al., 2012) will be used to measure quality of life in this study.
12 weeks

Collaborators and Investigators

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

Sponsor

Nam Dinh University of Nursing

Collaborators

The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

June 22, 2018

Study Registration Dates

First Submitted

November 26, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

November 30, 2016

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NamDUN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Later

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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