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The Vitality Project for Fatigued Female Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259438
Recruitment Status : Unknown
Verified August 2017 by Ellen Flynn, The Miriam Hospital.
Recruitment status was:  Recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Ellen Flynn, The Miriam Hospital

Brief Summary:

This parallel, randomized, non-inferiority trial will examine whether a ten week qigong intervention is not inferior to a ten week exercise-nutrition comparison group in reducing fatigue in cancer survivors. To build a more mechanistic understanding of physiological changes associated with fatigue reduction, it will secondly collect several different types of data to build an integrative brain-body model of vigor in cancer survivorship including:

  1. data related to neural correlates of body awareness: cortical EEG data measuring each subject's ability to use attention to control neurons in primary somatosensory cortex (replication of Kerr et al 2011 study in mindfulness), and resting state fMRI measures of insular connectivity with nodes of the default mode network and salience network
  2. data related to inflammation measured via inflammatory cytokines (e.g., interleukin-6 and tnf-alpha)
  3. data related to cardiorespiratory functioning including cardiac impedance (ICG) and mechanical lung function
  4. data related to parasympathetic and sympathetic signaling between the nervous system and the rest of the periphery.

Condition or disease Intervention/treatment Phase
Fatigue Cancer Survivorship Behavioral: Qigong Behavioral: Healthy Living (CHIP + Pre-Train) Not Applicable

Detailed Description:
The purpose of this study is to examine the therapeutic effects of movement and body awareness on recovery from cancer-related fatigue. In the current study, 60-80 female cancer survivors with cancer-related fatigue will be recruited who have been out of treatment for at least eight weeks. They will be randomized to either a 10-week qigong contemplative movement course or a 10 -week exercise-nutrition course. This study is designed as a non-inferiority trial to test the primary hypothesis that a ten week qigong intervention is not inferior to a ten week exercise-nutrition active comparator group in reducing fatigue in female cancer survivors (assessed via the FACIT-Fatigue scale). If non-inferiority is demonstrated during analysis, the data will be further analyzed to examine whether the qigong group significantly decreases fatigue more than the healthy living comparison group. The FACIT-Fatigue scale will be delivered at three time points: before the intervention starts (T1), after it ends (T2), and three months after the intervention has ended (T3). Further, this study will directly examine the underlying physiological mechanisms by which each intervention exerts its effects. Participants will be tested pre (T1) and post (T2) intervention on a variety of measures across multiple bodily and brain systems (eg EEG, fMRI, EMG, ECG, ICG, mechanical lung function, Doppler flowmetry, serum cytokines, muscle strength, 6 min walk test) to assess changes in these systems that are associated with reduction of fatigue and improvement of the subjective sense of vitality and energy. The data will be used to test whether conscious attention to bodily sensations cultivated in contemplative movement practices (i.e. Qigong) can actually impact levels of inflammation in the periphery as well as cortical measures of interoceptive awareness (ie resting state insula connectivity), and whether these changes will be associated with fatigue reduction. The secondary hypothesis is that decreased inflammation levels in the blood will be correlated with reduction in fatigue at post intervention as well as changes in neural markers of interoceptive and bodily awareness, and that this effect will be stronger in the qigong group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This parallel, randomized non-inferiority trial will test whether qigong is not inferior to an exercise/nutrition active comparator group in terms of reducing fatigue in female cancer survivors. If non-inferiority is demonstrated during analysis, a secondary analysis will test whether qigong can be considered superior to the exercise-nutrition comparator
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

Participants will not find out what interventional group they are placed in (qigong vs. healthy living) until after they have completed their first testing session.

Pre intervention data collection and post intervention data analysis will be completely masked.

Primary Purpose: Treatment
Official Title: Testing the Effects of Movement Based Interventions on Brain-Body Mechanisms in Fatigued Cancer Survivors
Actual Study Start Date : July 24, 2017
Estimated Primary Completion Date : December 20, 2017
Estimated Study Completion Date : January 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Qigong
This course will meet twice weekly for 2 hours and 15 minutes per class for ten weeks. Topics will include guided instruction in the theory and background of qigong and healing. Practice will include gentle stretching and guided qigong movement as well as seated and lying down meditations. Participants will be asked to complete about 30 minutes a day of home assignments.
Behavioral: Qigong
Qigong is a form of gentle mind-body movement that originates in China and has traditionally been used for healing purposes. It has been reported to improve energy levels, as well as strength and endurance and mental clarity and equanimity. This study will assess how a 10-week qigong intervention compares to an exercise-nutrition intervention in improving fatigue and vitality in female cancer survivors. On a secondary level, we will asses changes in underlying brain, heart, and peripheral dynamics that occur as a result of the qigong practice to develop a mechanistic understanding of qigong's efficacy.

Active Comparator: Healthy Living (CHIP + Pre-Train)
This course will meet twice weekly for 2 hours and 15 minutes per class for ten weeks. Topics will include plant based nutrition counseling via the Comprehensive Health Improvement Program (CHIP) as well as core-stretching, strengthening, and light aerobic movements through a Pre-Train exercise program. Participants will be asked to complete about 30 minutes a day of home assignments.
Behavioral: Healthy Living (CHIP + Pre-Train)
The Healthy Living active comparator intervention includes two components: plant based nutrition counseling via the Comprehensive Health Improvement Program (CHIP) and core strengthening exercises and light aerobic activity via the Pre-Train exercise program.




Primary Outcome Measures :
  1. Reduction in Fatigue (via FACIT-Fatigue scale) [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) ]
    Fatigue assessed via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire


Secondary Outcome Measures :
  1. Electrocardiogram (ECG) [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) ]
    Will be measured to calculate heart rate variability (HRV)

  2. Impedance Cardiography [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) ]
    Will be used to assess exercise related improvements in cardiovascular tone.

  3. Electroencephalography (EEG) [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) ]
    Will be used to assess changes in cortical brain waves (particularly alpha and beta rhythms)

  4. Tactile Acuity [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) ]
    A task that involves subtle taps to the finger tips, EEG is simultaneously recorded to examine modulation in brain rhythms across somatosensory cortex related to cued attention to the tap

  5. Electromyography (EMG) [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) ]
    A measure of muscle rhythms

  6. Precision Grip [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) ]
    A measure of one's ability to hold a lever at a steady force, EEG and EMG simultaneously record corticomuscular coherence that may facilitate steady grip

  7. Electrodermal Activity (skin conductance) [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) ]
    to assess sympathetic tone

  8. Working memory capacity (WMC) [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) ]
    Assessed via the short-form O-SPAN computer-based task to assess overall memory impairments

  9. Mechanical lung function [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) ]
    to determine the impact of exercise and movement on overall lung function

  10. Inflammatory cytokines (eg Il-1, Il-6) collected via a blood draw [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) ]
    To measure the interaction between the brain measures of bodily awareness and the immune system

  11. Resting State Functional Magnetic Resonance Imaging (rs-fMRI) [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) ]
    Optional measure: To assess changes in functional connectivity associated with participation in the intervention

  12. Muscle Strength [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) ]
    Assessed via jamar hand dynamometers and back, leg, and arm dynamometers to assess changes in muscle tone associated with the classes

  13. 6 Minute Walk Test [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) ]
    Test of how far a participant can walk in six minutes to assess overall endurance

  14. Patient Health Questionnaire [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) ]
    Measure of anxiety and depression

  15. Functional Assessment of cancer therapy-General (FACT-G) Questionnaire [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) ]
    Measure of physical, social, emotional, and functional well-being

  16. Multidimensional Assessment of Interoceptive Awareness (MAIA) Questionnaire [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) ]
    Questionnaire to measure subjectively reported interoceptive and bodily awareness (including body-specific sensations, emotions, and cognitions)

  17. Profile of Mood States (POMS) Questionnaire [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) ]
    To assess fatigue, vigor, and overall mood

  18. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) ]
    Measurement of sleep quality, habits, and patterns

  19. Rand 36-Item Short Form Health Survey (SF-36) [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) ]
    Measurement of overall quality of life

  20. Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) ]
    Measures multiple factors of emotional dysregulation

  21. Fatigue Symptom Inventory (FSI) [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) ]
    Measures overall fatigue interfrerence


Other Outcome Measures:
  1. Apple watches Heart Rate and Physical Steps Tracking [ Time Frame: Optional Measure: For those involved, tracked daily for five days before the intervention starts, for the 70 days during the 10-week intervention, and for five days after the intervention ends. ]
    Apple watches will be supplied to interested participants to monitor their heart rate and physical steps taken throughout the day to assess changes in movement patterns while participating in the classes

  2. Perceived Stress Scale (PSS) Questionnaire [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) ]
    To assess changes in self-reported stress

  3. Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) ]
    Measure of self-reported social support

  4. Unmitigated Communion Scale [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) ]
    A measure of a person's tendency to care for other's before themselves

  5. Godin Leisure time Questionnaire [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) ]
    Measure of how much a person has been excising or relaxing



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must be female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients
  • Aged 18-70 years
  • Have completed a course of chemotherapy cancer treatment (except for ongoing treatment with Herceptin [trastuzumab] or other adjuvant therapies), AND/OR radiation treatment, AND/OR surgery, with no surgery, radiation or chemotherapy received in the past 8 weeks.
  • Endorse a 3/10 or above for the question "On a scale of one to ten, in the last week, how much has your fatigue interfered with your daily life, with 1 being not at all, and 10 being all the time" AND/OR "On a scale of one to ten, in the last week, how much have you felt your sleep has been disturbed or of a quality that you have not felt rested when you wake up, with 1 being not at all, and 10 being all the time"
  • Have a primary care or other physician
  • Ability to understand English
  • Willingness to have blood drawn
  • Willingness to have an EEG, EKG, and EMG taken
  • Willingness to complete questionnaires
  • Willingness and ability to undergo an fMRI scan (screening parameters for this are included below) [optional: participant doesn't have to do this if it will represent too much burden to the participant, or if they have other contraindications to fMRI such as metal in the body, etc.]
  • 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 and exercise practices

Exclusion Criteria:

  • History or current diagnosis of coronary artery or coronary heart disease
  • History or current diagnosis of heart attack, or heart murmur
  • Electrical Pacemaker Implant in heart
  • Peripheral neuropathy in hands
  • History or current diagnosis of any other MAJOR psychiatric disorder (including psychosis, or mania, or suicidal or homicidal ideation) besides depression or anxiety
  • Active alcohol or drug abuse
  • Tobacco use
  • Pregnancy
  • Ingestion of caffeine or cocoa products less than two hours from data collection
  • Inability to participate in gentle exercises (like pilates)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259438


Contacts
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Contact: Chloe S Zimmerman, BA 401-863-6272 chloe_zimmerman@brown.edu

Locations
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United States, Rhode Island
Miriam Hospital Outpatient 146 West River Street Recruiting
Providence, Rhode Island, United States, 02904
Contact: Ellen Flynn, MD    401-793-7020    eflynn@lifespan.org   
Contact: Susan Martin, LDN, IBCLC    401-793-7822    smartin8@lifespan.org   
Sponsors and Collaborators
The Miriam Hospital
Brown University
Investigators
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Principal Investigator: Ellen Flynn, MD The Miriam Hospital
Publications:

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Responsible Party: Ellen Flynn, MD, Psychiatry, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT03259438    
Other Study ID Numbers: MiriamH 1040485
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No sharing plan anticipated.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ellen Flynn, The Miriam Hospital:
Qigong
Comprehensive Health Improvement Program (CHIP)
Pre-Train Injury Prevention Program
Cancer Related Fatigue
Cancer Survivorship
Inflammation
Flowmetry
Corticomuscular coherence
Heart Rate Variability
Neuroimmune Interactions
Complex Systems Analysis
Female
Additional relevant MeSH terms:
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Fatigue