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Evaluating Qigong as a Clinical Intervention for Cancer Survivors' Fatigue

Primary Purpose

Fatigue

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Qigong
Complete Health Improvement Program (CHIP)
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring Exercise, Qigong, Mind-Body, Fatigue, Cancer, EEG, HRV

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Miriam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Qigong intervention

CHIP healthy wellness-exercise class

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Fatigue Symptom Inventory Questionnaire
Questions about daily experience of fatigue

Secondary Outcome Measures

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

Full Information

First Posted
July 15, 2016
Last Updated
July 28, 2016
Sponsor
The Miriam Hospital
Collaborators
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT02845492
Brief Title
Evaluating Qigong as a Clinical Intervention for Cancer Survivors' Fatigue
Official Title
Testing the Effects of Qigong on a Multi-System Neuro-muscular- Immune Model of Vigor in Cancer Survivorship
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
Collaborators
Brown University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
Exercise, Qigong, Mind-Body, Fatigue, Cancer, EEG, HRV

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Qigong intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
CHIP healthy wellness-exercise class
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Qigong
Other Intervention Name(s)
Meditative Exercise Therapy
Intervention Description
Qigong is a mind-body exercise based around gentle exercise and the cultivation of a meditative focus on bodily sensations
Intervention Type
Other
Intervention Name(s)
Complete Health Improvement Program (CHIP)
Other Intervention Name(s)
Wellness-Exercise Program
Intervention Description
The CHIP program is a validated weekly wellness and exercise program designed to promote health and wellbeing.
Primary Outcome Measure Information:
Title
Fatigue Symptom Inventory Questionnaire
Description
Questions about daily experience of fatigue
Time Frame
Change from baseline to 10 weeks
Secondary Outcome Measure Information:
Title
EEG meditative brain measures,
Description
Acquired using a non-invasive EEG cap that sits on the scalp
Time Frame
at baseline and at 10 weeks
Title
Self-reported Vitality (a component of the Medical Outcomes Short-Form 36)
Time Frame
at baseline and 10 weeks
Title
Heart Rate Variability (HRV)
Description
Acquired using an EKG
Time Frame
at baseline and 10 weeks
Title
Inflammatory cytokines
Description
Cytokine measures: Il-1, Il-6, Il-10, tnf-alpha
Time Frame
at baseline and 10 weeks
Other Pre-specified Outcome Measures:
Title
Difficulties in emotion regulation self-report scale (DERS)
Description
Questions about emotions and emotion regulation
Time Frame
at baseline and 10 weeks
Title
Handgrip strength
Description
Uses dynamometer to assess handgrip strength
Time Frame
at baseline and 10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chloe Zimmerman, BA
Phone
4018636272
Email
chloe_zimmerman@brown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brendan Cullen, BA
Phone
4018636272
Email
Brendan_Cullen@brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Kerr, PhD
Organizational Affiliation
Women's Medicine Collaborative, Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloe Zimmerman
Phone
401-863-6272
Email
cancersurvivor@lifespan.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study data will be archived with with computer scripts into a package. These packages will be available to any investigator who requests them.
Citations:
PubMed Identifier
23408771
Citation
Kerr CE, Sacchet MD, Lazar SW, Moore CI, Jones SR. Mindfulness starts with the body: somatosensory attention and top-down modulation of cortical alpha rhythms in mindfulness meditation. Front Hum Neurosci. 2013 Feb 13;7:12. doi: 10.3389/fnhum.2013.00012. eCollection 2013.
Results Reference
background
PubMed Identifier
27199700
Citation
Schmalzl L, Kerr CE. Editorial: Neural Mechanisms Underlying Movement-Based Embodied Contemplative Practices. Front Hum Neurosci. 2016 Apr 26;10:169. doi: 10.3389/fnhum.2016.00169. eCollection 2016. No abstract available.
Results Reference
background

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Evaluating Qigong as a Clinical Intervention for Cancer Survivors' Fatigue

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