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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-06-22

Brief Summary

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Effects of Qigong on symptom clusters of dyspnea, fatigue, and anxiety in Vietnamese lung cancer patients: A randomized control trial

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Detailed Description

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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.

Conditions

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Lung Cancer, Nonsmall Cell Lung Cancer Non-Small Cell Stage 0 Lung Cancer, Nonsmall Cell, Stage I Lung Cancer Non-Small Cell Stage II Lung Cancer, Limited Stage Small Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The design of this study was a randomized controlled trial (RCT) with two parallel groups in a 1:1 allocation ratio, allocation concealment, and assessor blinding.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

In the current study, based on nature of the intervention, blinding was not feasible with researcher, statistician, Qigong master who were responsible for recruitment of subject, randomization, deliver the intervention. However, the investigators who collect the outcome information were blinded to the allocation sequence.

Study Groups

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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.

Group Type EXPERIMENTAL

Qigong

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Qigong

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Chi Kung

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No