Lung Cancer, Limited Stage Small Cell, Lung Cancer, Nonsmall Cell, Lung Cancer Non-Small Cell Stage 0, Lung Cancer, Nonsmall Cell, Stage I, Lung Cancer Non-Small Cell Stage II
Conditions
Keywords
dypsnea, fatigue, anxiety, Qigong, Lung cancer
Brief summary
Effects of Qigong on symptom clusters of dyspnea, fatigue, and anxiety in Vietnamese lung cancer patients: A randomized control trial
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.
Interventions
BEHAVIORALQigong
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.
Sponsors
The Hong Kong Polytechnic University
Nam Dinh University of Nursing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A cluster symptom of dyspnea, fatigue, and anxiety in lung cancer patients. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cough | 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. |
| Quality of Life | 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. |
Countries
Hong Kong
Outcome results
None listed