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

NCT02977845 | Completed

• 1 other identifier: NamDUN
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

dypsnea; fatigue; anxiety; Qigong; Lung cancer

Outcome Measures

Primary Outcomes (1)

• A cluster symptom of dyspnea, fatigue, and anxiety in lung cancer patients.

  * 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 Outcomes (2)

• Cough

  12 weeks

• Quality of Life

  12 weeks

Study Arms (2)

Primary aim

EXPERIMENTAL

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

Secondary aim

EXPERIMENTAL

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

Interventions

Qigong 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.

Also known as: Chi Kung

Primary aim; Secondary aim

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nam Dinh University of Nursing: lead
• The Hong Kong Polytechnic University: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

• Molassiotis A, Vu DV, Ching SSY. The Effectiveness of Qigong in Managing a Cluster of Symptoms (Breathlessness-Fatigue-Anxiety) in Patients with Lung Cancer: A Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211008253. doi: 10.1177/15347354211008253.

  PMID: 33847150 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Fatigue; Anxiety Disorders

Interventions

Qigong

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Breathing Exercises; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2016
• First Posted: November 30, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: June 22, 2018
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

HK (1)