Clinical trial NCT02977845: Effect of Qigong on the Symptom Clusters of Dyspnea, Fatigue, and Anxiety.
Official title: Effect of Qigong on the Symptom Clusters of Dyspnea, Fatigue, and Anxiety.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Nam Dinh University of Nursing
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
First posted: 2016-11-30
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

Eligibility 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

Primary outcomes:
measure: A cluster symptom of dyspnea, fatigue, and anxiety in lung cancer patients.
timeFrame: 12 weeks
Secondary outcomes:
measure: Cough
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References:
citation: 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.