Effect of Qigong on the Symptom Clusters of Dyspnea, Fatigue, and Anxiety.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- A cluster symptom of dyspnea, fatigue, and anxiety in lung cancer patients.
研究概览
简要总结
Effects of Qigong on symptom clusters of dyspnea, fatigue, and anxiety in Vietnamese lung cancer patients: A randomized control trial
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Qigong (Behavioral)
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.
干预措施: Qigong (Behavioral)
结局指标
主要结局
A cluster symptom of dyspnea, fatigue, and anxiety in lung cancer patients.
时间窗: 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.
次要结局
- Cough(12 weeks)
- Quality of Life(12 weeks)
研究者
VU VAN DAU
Senior lecturer
Nam Dinh University of Nursing