Qigong Mind-Body Exercise For Persistent Post-Surgical Pain In Breast Cancer Survivors: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Rate of completion of QMBE intervention
研究概览
简要总结
Studies have shown that on-going pain following breast surgery is common and may limit the ability to participate in physical activity, cause tiredness, difficulty in daily chores/activities as well as other problems.
This study is evaluating whether participating in a 12-week Qigong program (pronounced chee kung), an exercise program that involves gentle movements combined with breathing/relaxation techniques, also known as mind-body exercise, leads to improvement of pain, physical function, and quality of life among breast cancer survivors that have significant pain following surgery.
详细描述
This is a pilot/feasibility study designed to look at the potential benefits of a 12-week program of Qigong mind-body exercise program. The study applies to women who have completed physical therapy treatment on symptoms such as pain, and difficulty moving/strength of arm in women who are experiencing on-going symptoms after breast cancer surgery. The results of this study will be used to help design future studies of the effect of Qigong programs in breast cancer survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of Stage 0-III breast cancer;
- •Persistent post-surgical pain at least 3 months after completion of surgery, chemotherapy, and/or radiation;
- •Completion of a course of physical therapy
排除标准
- •Unstable cardiovascular disease in the last 6 months
- •Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder);
- •Metastatic breast or other cancer;
- •Participation in more than 240 minutes of moderate-intensity exercise per week (as determined by Leisure Score Index questionnaire)
- •Pregnant or breastfeeding
- •Recent history of attending regular QMBE or similar classes (e.g. yoga or tai chi classes), (i.e.20 or more classes in the past 6 months).
- •Currently enrolled in a physical therapy course
结局指标
主要结局
Rate of completion of QMBE intervention
时间窗: 12 months
Complete recruitment of target enrollment of 21 participants within 12 month timeframe.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 6 months
Total number of adverse events sustained from participation in QMBE will be collected for each participant through home practice logs for at home QMBE participation and instructors will report any adverse events that occur during QMBE class on attendance logs. Any adverse events observed will be evaluated according to the DFCI/Harvard Cancer Center guidelines. The study will be considered safe if zero adverse events are observed/reported from participation in prescribed QMBE classes and/or at home practice.
次要结局
- Shoulder Strength(3 months)
- Self-esteem(3 months)
- Changes in Quality of life(6 months)
- Anxiety & Depression(3 months)
- Stress Levels(3 months)
- Mindfulness(3 months)
- Degree of Pain(6 months)
- Gait & Postural Control(3 months)
- Grip Strength(3 months)
- Pain Catastrophizing(3 months)
- Fatigue(3 months)
- Range of Motion(3 months)
研究者
Jennifer A. Ligibel, MD
Dr., M.D.
Dana-Farber Cancer Institute