Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT02977845 |
Date of registration:
|
26/11/2016 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Effect of Qigong on the Symptom Clusters of Dyspnea, Fatigue, and Anxiety.
|
Scientific title:
|
Effect of Qigong on the Symptom Clusters of Dyspnea, Fatigue, and Anxiety. |
Date of first enrolment:
|
January 1, 2017 |
Target sample size:
|
162 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02977845 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Hong Kong
|
Vietnam
| | | | | | |
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Lung Cancer, Limited Stage Small Cell
|
Lung Cancer Non-Small Cell Stage II
|
Lung Cancer, Nonsmall Cell, Stage I
|
Lung Cancer Non-Small Cell Stage 0
|
Lung Cancer, Nonsmall Cell
|
Intervention(s)
|
Behavioral: Qigong
|
Primary Outcome(s)
|
A cluster symptom of dyspnea, fatigue, and anxiety in lung cancer patients.
[Time Frame: 12 weeks]
|
Secondary Outcome(s)
|
Cough
[Time Frame: 12 weeks]
|
Quality of Life
[Time Frame: 12 weeks]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|