<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02977845</url>
  </required_header>
  <id_info>
    <org_study_id>NamDUN</org_study_id>
    <nct_id>NCT02977845</nct_id>
  </id_info>
  <brief_title>Effect of Qigong on the Symptom Clusters of Dyspnea, Fatigue, and Anxiety.</brief_title>
  <official_title>Effect of Qigong on the Symptom Clusters of Dyspnea, Fatigue, and Anxiety.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nam Dinh University of Nursing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nam Dinh University of Nursing</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Effects of Qigong on symptom clusters of dyspnea, fatigue, and anxiety in Vietnamese lung&#xD;
      cancer patients: A randomized control trial&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Patients with lung cancer experience a variety of symptoms. The number of&#xD;
      symptoms ranged from 7.8 to 13.2, and most of them were at a moderate level of severity.&#xD;
      Dyspnea, fatigue, and anxiety arose as the most problematic symptoms of lung cancer.&#xD;
      Non-pharmacological approaches to manage of symptom among lung cancer patients showed either&#xD;
      no or mild effects. Qigong is hypothesized to alleviate these adverse outcomes; however, all&#xD;
      trial analyzed on a single symptom, and not lung cancer patients, and there have not been&#xD;
      many well-designed randomized control trials. The objectives of this study are following: 1)&#xD;
      to assess the effect of Qigong on managing dypsnea, fatigue, and anxiety (as a cluster) in&#xD;
      lung cancer patients; 2) to explore the effect of Qigong on cough another common symptom&#xD;
      linked with dyspnea, fatigue as a cluster and quality of life (QOL) in lung cancer patients.&#xD;
&#xD;
      Methods: 156 subjects with lung cancer (stage I - IV) will be randomized to either the Qigong&#xD;
      group or the wait-list control group. Participants in the Qigong group will conduct Qigong&#xD;
      practice 5 times per week for 6 weeks, and participants in the control group will receive&#xD;
      usual care. The primary outcome (dypsnea, fatigue, and anxiety), secondary outcomes (cough&#xD;
      and QOL) will be assessed at baseline, post-intervention, and post 6-weeks of follow-up.&#xD;
&#xD;
      Discussion: This study will be the first randomized trial to investigate the effectiveness of&#xD;
      Qigong for management symptom cluster in lung cancer patients. The finding of this study will&#xD;
      help to establish the optimal approach for the care of lung cancer patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">June 22, 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>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.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>A cluster symptom of dyspnea, fatigue, and anxiety in lung cancer patients.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Dyspnea is described as &quot;an uncomfortable awareness of breathing&quot; (DiSalvo, Joyce, Tyson, Culkin, &amp; Mackay, 2008). Cancer Dyspnoea Scale will be used to measure dypsnea in this study.&#xD;
Fatigue is defined as &quot;a subjective feeling of tiredness, weakness or lack of energy&quot; (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.&#xD;
Anxiety is defined as &quot;The apprehensive anticipation of future danger or misfortune accompanied by a feeling of dysphoria or somatic symptoms of tension&quot; (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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cough</measure>
    <time_frame>12 weeks</time_frame>
    <description>Cough is &quot;a forced expulsive manoeuvre, usually against a closed glottis and which is associated with a characteristic sound&quot; (McGarvey &amp; Morice, 2006; Pavord &amp; Chung, 2008). Manchester Cough in Lung Cancer Scale (MCLCS) (Molassiotis et al., 2012) will be used to measure cough in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>12 weeks</time_frame>
    <description>The World Health Organization (WHO) defined health as &quot;a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity&quot;. 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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Lung Cancer, Nonsmall Cell</condition>
  <condition>Lung Cancer Non-Small Cell Stage 0</condition>
  <condition>Lung Cancer, Nonsmall Cell, Stage I</condition>
  <condition>Lung Cancer Non-Small Cell Stage II</condition>
  <condition>Lung Cancer, Limited Stage Small Cell</condition>
  <arm_group>
    <arm_group_label>Primary aim</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Secondary aim</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Qigong</intervention_name>
    <description>Qigong has long been regarded as a form of &quot;mind-body&quot; intervention in Traditional Chinese Medicine (TCM), which simultaneously exercises the &quot;mind&quot; and the &quot;body&quot; 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 &quot;Health Qigong&quot;. It is different from &quot;Medical Qigong&quot; which involves a TCM practitioner to emit &quot;Qi&quot; to heal the patients.</description>
    <arm_group_label>Primary aim</arm_group_label>
    <arm_group_label>Secondary aim</arm_group_label>
    <other_name>Chi Kung</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed of lung cancer [Non-small cell lung cancer (NSCLC) or Small cell lung cancer&#xD;
             (SCLC)];&#xD;
&#xD;
          -  Patients with Stage I - III NSCLC or SCLC and have completed treatment with&#xD;
             chemotherapy and/or radiotherapy for a minimum of 4 weeks prior to commencing the&#xD;
             study;&#xD;
&#xD;
          -  Medically fit to participate in general well-being and activities of daily life, as&#xD;
             two or smaller on a 0 - to 5-point numeric rating scale at the time of recruitment, as&#xD;
             determined by The Eastern Cooperative Oncology Group (ECOG) score;&#xD;
&#xD;
          -  With no evidence of recurrence or occurrence of other cancers; and&#xD;
&#xD;
          -  Patients report all three symptoms (dyspnea, fatigue, and anxiety) in the previous&#xD;
             week and ranked the severity of at least two of the three symptoms as 3 or more on a 0&#xD;
             - to 10-point numeric rating scale at the time of recruitment, as determined by&#xD;
             dyspnea, fatigue, and anxiety intensity rating scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically diagnosed with major psychiatric illness;&#xD;
&#xD;
          -  Presenting with criteria associated with risk during physical activity: severe&#xD;
             cachexia; frequent dizziness; bone pain; or severe nausea;&#xD;
&#xD;
          -  Having had past or current regular experience with mind-body practices that blend&#xD;
             movement with meditative practices, such as Yoga, Tai Chi, or Qigong;&#xD;
&#xD;
          -  Life expectancy of &lt; 6 months (as determined by their physicians).&#xD;
&#xD;
          -  Visual problems or deafness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Hong Kong Polytechnic University</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <removed_countries>
    <country>Vietnam</country>
  </removed_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>November 26, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>June 26, 2018</last_update_submitted>
  <last_update_submitted_qc>June 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nam Dinh University of Nursing</investigator_affiliation>
    <investigator_full_name>VU VAN DAU</investigator_full_name>
    <investigator_title>Senior lecturer</investigator_title>
  </responsible_party>
  <keyword>dypsnea</keyword>
  <keyword>fatigue</keyword>
  <keyword>anxiety</keyword>
  <keyword>Qigong</keyword>
  <keyword>Lung cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Dyspnea</mesh_term>
    <mesh_term>Fatigue</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Later</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02977845
org study id: NamDUN
nct id: NCT02977845
lead sponsor: 
collaborator: 
has dmc: No
Effects of Qigong on symptom clusters of dyspnea, fatigue, and anxiety in Vietnamese lung
      cancer patients: A randomized control trial
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 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 purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: 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.
measure: A cluster symptom of dyspnea, fatigue, and anxiety in lung cancer patients.
time frame: 12 weeks
description: 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.
measure: Cough
time frame: 12 weeks
description: 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.
measure: Quality of Life
time frame: 12 weeks
description: 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.
arm group label: Primary aim
arm group type: Experimental
description: 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.
arm group label: Secondary aim
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: Qigong
description: 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.
arm group label: Primary aim
arm group label: Secondary aim
other name: Chi Kung
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Hong Kong
country: Vietnam
responsible party type: Principal Investigator
investigator affiliation: Nam Dinh University of Nursing
investigator full name: VU VAN DAU
investigator title: Senior lecturer
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Dyspnea
mesh term: Fatigue
mesh term: Syndrome
sharing ipd: Undecided
ipd description: Later