Evaluating Qigong as a Clinical Intervention for Cancer Survivors' Fatigue

Study Overview
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Brief Summary
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This study compares Qigong movement-based meditation exercise with a healthy living exercise-wellness course. There are two primary goals of this research: Evaluate and compare physiological mechanisms underlying the two wellness-exercise interventions with the specific goal of understanding the physiology of Qigong. Using a simple noninvasive EEG setup, the study will test some of the same brain mechanisms that have been found in mindfulness meditation. The study will also investigate Qigong's effects on stress and heart signals and on inflammation in the immune system. A key hypothesis is that Qigong will show distinctive, stronger effects on brain and heart measures. A related hypothesis is that Qigong will show stronger effects on blood markers of inflammation. Compare effect sizes of the two interventions in decreasing fatigue in order to plan for a larger clinical trial.

Detailed Description
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Between 20-50% of Cancer Survivors report fatigue following treatment that interferes with their daily life. However, to date no treatment option has been definitively validated as effective for fatigue in survivors. In recent years Mind Body exercises such as yoga, Tai Chi, and Qigong have been shown in small clinical trials to be effective at treating the symptoms of CRF in a wide array of Cancer types. But understanding of basic science mechanisms is poor. Recent studies of Mindfulness meditation, by the investigators and others, confirm the importance of brain mechanisms related to awareness and attention. This study will assess whether Qigong activates similar physiological processes. The study will also assess (1) whether emotion regulation improves, suggesting that Mindfulness-related processes may partially underlie changes in Qigong as a Mindful exercise (2) whether grip strength improves, suggesting that Qigong activates similar processes to conventional exercise. As an exploratory question, the study will look at whether brain measures related to awareness are correlated with inflammatory markers called cytokines, suggesting possible neuro-immune interaction that may be relevant for understanding fatigue, vitality and embodied meditative movement therapies such as Qigong, Tai Chi and Yoga.

Official Title
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Testing the Effects of Qigong on a Multi-System Neuro-muscular- Immune Model of Vigor in Cancer Survivorship

Conditions
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Fatigue

Intervention / Treatment
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* Other: Qigong
* Other: Complete Health Improvement Program (CHIP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients Aged 18-70 years Self-report of fatigue =/> 3/10 on fatigue interference scale Have been diagnosed and completed treatment for cancer (with surgery or radiation or chemotherapy) no surgery, radiation or chemotherapy received in the past 8 weeks (ongoing treatment with Herceptin [trastuzumab] or other adjuvant therapies is permitted) Currently cancer-free Have a primary care or other physician Ability to understand English Willingness to have blood drawn, have an EEG taken and complete questionnaires Ability to pass basic validated physical movement tests (e.g.: standing with feet touching for 30 seconds, twist right to left and back, hold arms out to side in air for 15 seconds, lift arms over head, moving from standing position to seated position on the floor) to verify safety for Qigong practice. Exclusion Criteria: History or current diagnosis of medical or psychiatric disorder that would interfere with ability to participate in wellness classes or in scientific assessment sessions (e.g., rheumatoid arthritis, diabetes, major psychiatric disorder, connective tissue disorder) Body Mass Index (BMI) > 31 Active alcohol or drug abuse Tobacco use Pregnancy Regular daily use of anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs, (does not apply to common use of daily baby aspirin as daily prophylactic cardiovascular treatment) Resting systolic blood pressure of less than 90 or greater than 160 and resting diastolic blood pressure of greater than 110. Ingestion of caffeine or cocoa products less than two hours from data collection Contraindication to regular physical activity participation Already engaging in >60 min of vigorous physical activity per week for the prior month Weekly practice of yoga, Tai Chi, Qigong, or meditation since the diagnosis of cancer Peripheral neuropathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qigong intervention<br>Qigong meditative exercise intervention meets three times a week for 10 weeks. The qigong group (n=30) will meet at the Women's Medicine Collaborative, Miriam Hospital (146 W. River St., Providence, RI) for Qigong classes. The lesson will be taught by a validated Qi Gong master with over forty years of experience and the interventional protocol will be validated. Two and a half hours of weekly outside personal practice will also be required of participants. | Other: Qigong<br>* Qigong is a mind-body exercise based around gentle exercise and the cultivation of a meditative focus on bodily sensations<br>* Other names: Meditative Exercise Therapy;|
| Active Comparator: CHIP healthy wellness-exercise class<br>The Complete Health Improvement Program is a validated set of weekly classes designed to promote gentle exercise and wellness related activities in a supportive group setting led by an experienced trainer. | Other: Complete Health Improvement Program (CHIP)<br>* The CHIP program is a validated weekly wellness and exercise program designed to promote health and wellbeing.<br>* Other names: Wellness-Exercise Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Symptom Inventory Questionnaire | Questions about daily experience of fatigue | Change from baseline to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG meditative brain measures, | Acquired using a non-invasive EEG cap that sits on the scalp | at baseline and at 10 weeks | 
| Self-reported Vitality (a component of the Medical Outcomes Short-Form 36) |  | at baseline and 10 weeks | 
| Heart Rate Variability (HRV) | Acquired using an EKG | at baseline and 10 weeks | 
| Inflammatory cytokines | Cytokine measures: Il-1, Il-6, Il-10, tnf-alpha | at baseline and 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Qigong, Mind-Body, Fatigue, Cancer, EEG, HRV