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临床试验/NCT03136575
NCT03136575Unknown不适用

The Impact of the Digital Traditional Qigong Regimen Exercises on Quality of Life and Sleep Disturbance in Head and Neck Patients Undergoing Radiotherapy

Kaohsiung Medical University Chung-Ho Memorial Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年3月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Change of quality of life

研究概览

简要总结

This study aimed to observe how a six week qigong program influence patients with head and neck cancer during active radiotherapy treatment course. The quality of life, sleep dysfunction or depression and shoulder and neck function will be accessed by questionnaire, and ANS function will be objectively investigated using heart rate variability measurement.

详细描述

The incidence of head and neck cancers is the 6th in Taiwan, and head and neck cancers are the 5th leading cause of cancer death, causing approximately 2000 death in 2010. Head and neck cancers patients usually require multimodality treatments, including surgery, chemotherapy and radiotherapy. These treatments can cause functional deterioration and worsened quality of life during or after the treatment, and bring tremendous effects on patient's life. When radiotherapy is indicated, it requires 6 to 7 weeks treatment, and most patients suffered from different degrees of mucositis, dermatitis, xerostomia and neck and shoulder tightness during radiotherapy. How to improve quality of life for these patients during radiotherapy is an important task.

Qigong is a mind-body exercise or therapy; it can improve quality of life, such as fatigue, sleep dysfunction and depression through regulation of breath and simple physical exercise. Some found that the qigong can decrease inflammation and show some impact on accommodation of ANS in cancer patients. Most studies focus on how qigong effect on cancer survivors, however, this study is aimed to observe how a six week qigong program influence patients with head and neck cancer during active radiotherapy treatment course. The quality of life, sleep dysfunction or depression and shoulder and neck function will be accessed by questionnaire, and ANS function will be objectively investigated using heart rate variability measurement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

patients who signed inform consent are randomized into qigong group and wait-list control (WLC)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Clinical diagnosis of Head and neck squamous cell carcinoma, subsites including nasopharyngeal cancer, oropharyngeal cancer, oral cancer, hypopharyngeal cancer and laryngeal cancer Performance status ECOG 0-1 Physically able to participate in the qigong program

排除标准

  • Previous radiotherapy to head and neck region Patients who refused to sign the informed consents Patients who took antihypertensive drugs, sedatives, or antiarrhythmic drugs

研究组 & 干预措施

Qigong

Active Comparator

Patients in the Qigong group receive Qigong,a mind-body exercise, 3 times a week, for 6 weeks during radiotherapy course. The participants are given a DVD contains Qigong program, and they attend the Qigong class in a health education room at the radiation oncology department to assure their attendance.

干预措施: Qigong (Behavioral)

wait-list control

Placebo Comparator

Patients who are assigned to the wait-list control are told to have some exercise by their own but no actually attend the the class in fact.

干预措施: Wait-list control (Behavioral)

结局指标

主要结局

Change of quality of life

时间窗: before radiotherapy starts and after radiotherapy complete. (The duration of radiotherapy course is usually about 6 to 7 weeks)

The changes of quality of life before radiotherapy and after radiotherapy complete are evaluated using University of Washington Quality of Life Questionnaire (UW-QOL) to access the quality of life

Change of Autonomic nervous system (ANS) function

时间窗: before radiotherapy start and after radiotherapy complete(The duration of radiotherapy course is usually about 6 to 7 weeks)

The change of ANS function is accessed by heart rate variability

Change of depression and anxiety

时间窗: before radiotherapy start and after radiotherapy complete. (The duration of radiotherapy course is usually about 6 to 7 weeks)

The changes of the level of depression and anxiety before radiotherapy and after radiotherapy complete are accessed using hospital anxiety and depression scale (HADS)

Change of sleep quality

时间窗: before radiotherapy start and after radiotherapy complete (The duration of radiotherapy course is usually about 6 to 7 weeks)

The change of sleep quality is evaluated using Pittsburgh Sleep Quality Index (PSQI)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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