<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03259438</url>
  </required_header>
  <id_info>
    <org_study_id>MiriamH 1040485</org_study_id>
    <nct_id>NCT03259438</nct_id>
  </id_info>
  <brief_title>The Vitality Project for Fatigued Female Cancer Survivors</brief_title>
  <official_title>Testing the Effects of Movement Based Interventions on Brain-Body Mechanisms in Fatigued Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Miriam Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Miriam Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This parallel, randomized, non-inferiority trial will examine whether a ten week qigong&#xD;
      intervention is not inferior to a ten week exercise-nutrition comparison group in reducing&#xD;
      fatigue in cancer survivors. To build a more mechanistic understanding of physiological&#xD;
      changes associated with fatigue reduction, it will secondly collect several different types&#xD;
      of data to build an integrative brain-body model of vigor in cancer survivorship including:&#xD;
&#xD;
        1. data related to neural correlates of body awareness: cortical EEG data measuring each&#xD;
           subject's ability to use attention to control neurons in primary somatosensory cortex&#xD;
           (replication of Kerr et al 2011 study in mindfulness), and resting state fMRI measures&#xD;
           of insular connectivity with nodes of the default mode network and salience network&#xD;
&#xD;
        2. data related to inflammation measured via inflammatory cytokines (e.g., interleukin-6&#xD;
           and tnf-alpha)&#xD;
&#xD;
        3. data related to cardiorespiratory functioning including cardiac impedance (ICG) and&#xD;
           mechanical lung function&#xD;
&#xD;
        4. data related to parasympathetic and sympathetic signaling between the nervous system and&#xD;
           the rest of the periphery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to examine the therapeutic effects of movement and body&#xD;
      awareness on recovery from cancer-related fatigue. In the current study, 60-80 female cancer&#xD;
      survivors with cancer-related fatigue will be recruited who have been out of treatment for at&#xD;
      least eight weeks. They will be randomized to either a 10-week qigong contemplative movement&#xD;
      course or a 10 -week exercise-nutrition course. This study is designed as a non-inferiority&#xD;
      trial to test the primary hypothesis that a ten week qigong intervention is not inferior to a&#xD;
      ten week exercise-nutrition active comparator group in reducing fatigue in female cancer&#xD;
      survivors (assessed via the FACIT-Fatigue scale). If non-inferiority is demonstrated during&#xD;
      analysis, the data will be further analyzed to examine whether the qigong group significantly&#xD;
      decreases fatigue more than the healthy living comparison group. The FACIT-Fatigue scale will&#xD;
      be delivered at three time points: before the intervention starts (T1), after it ends (T2),&#xD;
      and three months after the intervention has ended (T3). Further, this study will directly&#xD;
      examine the underlying physiological mechanisms by which each intervention exerts its&#xD;
      effects. Participants will be tested pre (T1) and post (T2) intervention on a variety of&#xD;
      measures across multiple bodily and brain systems (eg EEG, fMRI, EMG, ECG, ICG, mechanical&#xD;
      lung function, Doppler flowmetry, serum cytokines, muscle strength, 6 min walk test) to&#xD;
      assess changes in these systems that are associated with reduction of fatigue and improvement&#xD;
      of the subjective sense of vitality and energy. The data will be used to test whether&#xD;
      conscious attention to bodily sensations cultivated in contemplative movement practices (i.e.&#xD;
      Qigong) can actually impact levels of inflammation in the periphery as well as cortical&#xD;
      measures of interoceptive awareness (ie resting state insula connectivity), and whether these&#xD;
      changes will be associated with fatigue reduction. The secondary hypothesis is that decreased&#xD;
      inflammation levels in the blood will be correlated with reduction in fatigue at post&#xD;
      intervention as well as changes in neural markers of interoceptive and bodily awareness, and&#xD;
      that this effect will be stronger in the qigong group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Anticipated">January 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <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.&#xD;
Pre intervention data collection and post intervention data analysis will be completely masked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in Fatigue (via FACIT-Fatigue scale)</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)</time_frame>
    <description>Fatigue assessed via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Electrocardiogram (ECG)</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2)</time_frame>
    <description>Will be measured to calculate heart rate variability (HRV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impedance Cardiography</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2)</time_frame>
    <description>Will be used to assess exercise related improvements in cardiovascular tone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electroencephalography (EEG)</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2)</time_frame>
    <description>Will be used to assess changes in cortical brain waves (particularly alpha and beta rhythms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tactile Acuity</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2)</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electromyography (EMG)</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2)</time_frame>
    <description>A measure of muscle rhythms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Precision Grip</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2)</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrodermal Activity (skin conductance)</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2)</time_frame>
    <description>to assess sympathetic tone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working memory capacity (WMC)</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2)</time_frame>
    <description>Assessed via the short-form O-SPAN computer-based task to assess overall memory impairments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical lung function</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2)</time_frame>
    <description>to determine the impact of exercise and movement on overall lung function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory cytokines (eg Il-1, Il-6) collected via a blood draw</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2)</time_frame>
    <description>To measure the interaction between the brain measures of bodily awareness and the immune system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting State Functional Magnetic Resonance Imaging (rs-fMRI)</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2)</time_frame>
    <description>Optional measure: To assess changes in functional connectivity associated with participation in the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2)</time_frame>
    <description>Assessed via jamar hand dynamometers and back, leg, and arm dynamometers to assess changes in muscle tone associated with the classes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 Minute Walk Test</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2)</time_frame>
    <description>Test of how far a participant can walk in six minutes to assess overall endurance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)</time_frame>
    <description>Measure of anxiety and depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment of cancer therapy-General (FACT-G) Questionnaire</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)</time_frame>
    <description>Measure of physical, social, emotional, and functional well-being</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Assessment of Interoceptive Awareness (MAIA) Questionnaire</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)</time_frame>
    <description>Questionnaire to measure subjectively reported interoceptive and bodily awareness (including body-specific sensations, emotions, and cognitions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Profile of Mood States (POMS) Questionnaire</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)</time_frame>
    <description>To assess fatigue, vigor, and overall mood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)</time_frame>
    <description>Measurement of sleep quality, habits, and patterns</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rand 36-Item Short Form Health Survey (SF-36)</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)</time_frame>
    <description>Measurement of overall quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulties in Emotion Regulation Scale (DERS)</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)</time_frame>
    <description>Measures multiple factors of emotional dysregulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Symptom Inventory (FSI)</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)</time_frame>
    <description>Measures overall fatigue interfrerence</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Apple watches Heart Rate and Physical Steps Tracking</measure>
    <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.</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived Stress Scale (PSS) Questionnaire</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)</time_frame>
    <description>To assess changes in self-reported stress</description>
  </other_outcome>
  <other_outcome>
    <measure>Multidimensional Scale of Perceived Social Support (MSPSS)</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)</time_frame>
    <description>Measure of self-reported social support</description>
  </other_outcome>
  <other_outcome>
    <measure>Unmitigated Communion Scale</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)</time_frame>
    <description>A measure of a person's tendency to care for other's before themselves</description>
  </other_outcome>
  <other_outcome>
    <measure>Godin Leisure time Questionnaire</measure>
    <time_frame>Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)</time_frame>
    <description>Measure of how much a person has been excising or relaxing</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Fatigue</condition>
  <condition>Cancer Survivorship</condition>
  <arm_group>
    <arm_group_label>Qigong</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Living (CHIP + Pre-Train)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Qigong</intervention_name>
    <description>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.</description>
    <arm_group_label>Qigong</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Living (CHIP + Pre-Train)</intervention_name>
    <description>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.</description>
    <arm_group_label>Healthy Living (CHIP + Pre-Train)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients&#xD;
&#xD;
          -  Aged 18-70 years&#xD;
&#xD;
          -  Have completed a course of chemotherapy cancer treatment (except for ongoing treatment&#xD;
             with Herceptin [trastuzumab] or other adjuvant therapies), AND/OR radiation treatment,&#xD;
             AND/OR surgery, with no surgery, radiation or chemotherapy received in the past 8&#xD;
             weeks.&#xD;
&#xD;
          -  Endorse a 3/10 or above for the question &quot;On a scale of one to ten, in the last week,&#xD;
             how much has your fatigue interfered with your daily life, with 1 being not at all,&#xD;
             and 10 being all the time&quot; AND/OR &quot;On a scale of one to ten, in the last week, how&#xD;
             much have you felt your sleep has been disturbed or of a quality that you have not&#xD;
             felt rested when you wake up, with 1 being not at all, and 10 being all the time&quot;&#xD;
&#xD;
          -  Have a primary care or other physician&#xD;
&#xD;
          -  Ability to understand English&#xD;
&#xD;
          -  Willingness to have blood drawn&#xD;
&#xD;
          -  Willingness to have an EEG, EKG, and EMG taken&#xD;
&#xD;
          -  Willingness to complete questionnaires&#xD;
&#xD;
          -  Willingness and ability to undergo an fMRI scan (screening parameters for this are&#xD;
             included below) [optional: participant doesn't have to do this if it will represent&#xD;
             too much burden to the participant, or if they have other contraindications to fMRI&#xD;
             such as metal in the body, etc.]&#xD;
&#xD;
          -  Ability to pass basic validated physical movement tests (e.g.: standing with feet&#xD;
             touching for 30 seconds, twist right to left and back, hold arms out to side in air&#xD;
             for 15 seconds, lift arms over head, moving from standing position to seated position&#xD;
             on the floor) to verify safety for qigong and exercise practices&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or current diagnosis of coronary artery or coronary heart disease&#xD;
&#xD;
          -  History or current diagnosis of heart attack, or heart murmur&#xD;
&#xD;
          -  Electrical Pacemaker Implant in heart&#xD;
&#xD;
          -  Peripheral neuropathy in hands&#xD;
&#xD;
          -  History or current diagnosis of any other MAJOR psychiatric disorder (including&#xD;
             psychosis, or mania, or suicidal or homicidal ideation) besides depression or anxiety&#xD;
&#xD;
          -  Active alcohol or drug abuse&#xD;
&#xD;
          -  Tobacco use&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Ingestion of caffeine or cocoa products less than two hours from data collection&#xD;
&#xD;
          -  Inability to participate in gentle exercises (like pilates)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Must be female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ellen Flynn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Miriam Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chloe S Zimmerman, BA</last_name>
    <phone>401-863-6272</phone>
    <email>chloe_zimmerman@brown.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Miriam Hospital Outpatient 146 West River Street</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02904</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ellen Flynn, MD</last_name>
      <phone>401-793-7020</phone>
      <email>eflynn@lifespan.org</email>
    </contact>
    <contact_backup>
      <last_name>Susan Martin, LDN, IBCLC</last_name>
      <phone>401-793-7822</phone>
      <email>smartin8@lifespan.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Farb N, Daubenmier J, Price CJ, Gard T, Kerr C, Dunn BD, Klein AC, Paulus MP, Mehling WE. Interoception, contemplative practice, and health. Front Psychol. 2015 Jun 9;6:763. doi: 10.3389/fpsyg.2015.00763. eCollection 2015.</citation>
    <PMID>26106345</PMID>
  </reference>
  <reference>
    <citation>Desbordes G, Gard T, Hoge EA, Holzel BK, Kerr C, Lazar SW, Olendzki A, Vago DR. Moving beyond Mindfulness: Defining Equanimity as an Outcome Measure in Meditation and Contemplative Research. Mindfulness (N Y). 2014 Jan 21;2014(January):356-72. doi: 10.1007/s12671-013-0269-8.</citation>
    <PMID>25750687</PMID>
  </reference>
  <reference>
    <citation>Wells RE, Yeh GY, Kerr CE, Wolkin J, Davis RB, Tan Y, Spaeth R, Wall RB, Walsh J, Kaptchuk TJ, Press D, Phillips RS, Kong J. Meditation's impact on default mode network and hippocampus in mild cognitive impairment: a pilot study. Neurosci Lett. 2013 Nov 27;556:15-9. doi: 10.1016/j.neulet.2013.10.001. Epub 2013 Oct 10.</citation>
    <PMID>24120430</PMID>
  </reference>
  <reference>
    <citation>Daubenmier J, Sze J, Kerr CE, Kemeny ME, Mehling W. Follow your breath: respiratory interoceptive accuracy in experienced meditators. Psychophysiology. 2013 Aug;50(8):777-89. doi: 10.1111/psyp.12057. Epub 2013 May 22.</citation>
    <PMID>23692525</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23408771</PMID>
  </reference>
  <reference>
    <citation>Kerr CE, Jones SR, Wan Q, Pritchett DL, Wasserman RH, Wexler A, Villanueva JJ, Shaw JR, Lazar SW, Kaptchuk TJ, Littenberg R, Hamalainen MS, Moore CI. Effects of mindfulness meditation training on anticipatory alpha modulation in primary somatosensory cortex. Brain Res Bull. 2011 May 30;85(3-4):96-103. doi: 10.1016/j.brainresbull.2011.03.026. Epub 2011 Apr 8.</citation>
    <PMID>21501665</PMID>
  </reference>
  <reference>
    <citation>Mehling WE, Wrubel J, Daubenmier JJ, Price CJ, Kerr CE, Silow T, Gopisetty V, Stewart AL. Body Awareness: a phenomenological inquiry into the common ground of mind-body therapies. Philos Ethics Humanit Med. 2011 Apr 7;6:6. doi: 10.1186/1747-5341-6-6.</citation>
    <PMID>21473781</PMID>
  </reference>
  <reference>
    <citation>Kerr CE, Shaw JR, Wasserman RH, Chen VW, Kanojia A, Bayer T, Kelley JM. Tactile acuity in experienced Tai Chi practitioners: evidence for use dependent plasticity as an effect of sensory-attentional training. Exp Brain Res. 2008 Jun;188(2):317-22. doi: 10.1007/s00221-008-1409-6. Epub 2008 May 30.</citation>
    <PMID>18512052</PMID>
  </reference>
  <reference>
    <citation>Lazar SW, Kerr CE, Wasserman RH, Gray JR, Greve DN, Treadway MT, McGarvey M, Quinn BT, Dusek JA, Benson H, Rauch SL, Moore CI, Fischl B. Meditation experience is associated with increased cortical thickness. Neuroreport. 2005 Nov 28;16(17):1893-7. doi: 10.1097/01.wnr.0000186598.66243.19.</citation>
    <PMID>16272874</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Miriam Hospital</investigator_affiliation>
    <investigator_full_name>Ellen Flynn</investigator_full_name>
    <investigator_title>MD, Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Qigong</keyword>
  <keyword>Comprehensive Health Improvement Program (CHIP)</keyword>
  <keyword>Pre-Train Injury Prevention Program</keyword>
  <keyword>Cancer Related Fatigue</keyword>
  <keyword>Cancer Survivorship</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Flowmetry</keyword>
  <keyword>Corticomuscular coherence</keyword>
  <keyword>Heart Rate Variability</keyword>
  <keyword>Neuroimmune Interactions</keyword>
  <keyword>Complex Systems Analysis</keyword>
  <keyword>Female</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No sharing plan anticipated.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03259438
org study id: MiriamH 1040485
nct id: NCT03259438
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
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
primary purpose: Treatment
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.
measure: 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)
description: Fatigue assessed via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire
measure: Electrocardiogram (ECG)
time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
description: Will be measured to calculate heart rate variability (HRV)
measure: Impedance Cardiography
time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
description: Will be used to assess exercise related improvements in cardiovascular tone.
measure: Electroencephalography (EEG)
time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
description: Will be used to assess changes in cortical brain waves (particularly alpha and beta rhythms)
measure: Tactile Acuity
time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
description: 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
measure: Electromyography (EMG)
time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
description: A measure of muscle rhythms
measure: Precision Grip
time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
description: 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
measure: Electrodermal Activity (skin conductance)
time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
description: to assess sympathetic tone
measure: Working memory capacity (WMC)
time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
description: Assessed via the short-form O-SPAN computer-based task to assess overall memory impairments
measure: Mechanical lung function
time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
description: to determine the impact of exercise and movement on overall lung function
measure: 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)
description: To measure the interaction between the brain measures of bodily awareness and the immune system
measure: Resting State Functional Magnetic Resonance Imaging (rs-fMRI)
time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
description: Optional measure: To assess changes in functional connectivity associated with participation in the intervention
measure: Muscle Strength
time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
description: Assessed via jamar hand dynamometers and back, leg, and arm dynamometers to assess changes in muscle tone associated with the classes
measure: 6 Minute Walk Test
time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
description: Test of how far a participant can walk in six minutes to assess overall endurance
measure: 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)
description: Measure of anxiety and depression
measure: 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)
description: Measure of physical, social, emotional, and functional well-being
measure: 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)
description: Questionnaire to measure subjectively reported interoceptive and bodily awareness (including body-specific sensations, emotions, and cognitions)
measure: 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)
description: To assess fatigue, vigor, and overall mood
measure: 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)
description: Measurement of sleep quality, habits, and patterns
measure: 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)
description: Measurement of overall quality of life
measure: 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)
description: Measures multiple factors of emotional dysregulation
measure: 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)
description: Measures overall fatigue interfrerence
measure: 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.
description: 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
measure: 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)
description: To assess changes in self-reported stress
measure: 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)
description: Measure of self-reported social support
measure: 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)
description: A measure of a person's tendency to care for other's before themselves
measure: 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)
description: Measure of how much a person has been excising or relaxing
arm group label: Qigong
arm group type: Experimental
description: 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.
arm group label: Healthy Living (CHIP + Pre-Train)
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: Qigong
description: 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.
arm group label: Qigong
intervention type: Behavioral
intervention name: Healthy Living (CHIP + Pre-Train)
description: 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.
arm group label: Healthy Living (CHIP + Pre-Train)
criteria: 
gender: Female
gender based: Yes
gender description: Must be female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ellen Flynn, MD
role: Principal Investigator
affiliation: The Miriam Hospital
last name: Chloe S Zimmerman, BA
phone: 401-863-6272
email: chloe_zimmerman@brown.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Farb N, Daubenmier J, Price CJ, Gard T, Kerr C, Dunn BD, Klein AC, Paulus MP, Mehling WE. Interoception, contemplative practice, and health. Front Psychol. 2015 Jun 9;6:763. doi: 10.3389/fpsyg.2015.00763. eCollection 2015.
PMID: 26106345
citation: Desbordes G, Gard T, Hoge EA, Holzel BK, Kerr C, Lazar SW, Olendzki A, Vago DR. Moving beyond Mindfulness: Defining Equanimity as an Outcome Measure in Meditation and Contemplative Research. Mindfulness (N Y). 2014 Jan 21;2014(January):356-72. doi: 10.1007/s12671-013-0269-8.
PMID: 25750687
citation: Wells RE, Yeh GY, Kerr CE, Wolkin J, Davis RB, Tan Y, Spaeth R, Wall RB, Walsh J, Kaptchuk TJ, Press D, Phillips RS, Kong J. Meditation's impact on default mode network and hippocampus in mild cognitive impairment: a pilot study. Neurosci Lett. 2013 Nov 27;556:15-9. doi: 10.1016/j.neulet.2013.10.001. Epub 2013 Oct 10.
PMID: 24120430
citation: Daubenmier J, Sze J, Kerr CE, Kemeny ME, Mehling W. Follow your breath: respiratory interoceptive accuracy in experienced meditators. Psychophysiology. 2013 Aug;50(8):777-89. doi: 10.1111/psyp.12057. Epub 2013 May 22.
PMID: 23692525
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.
PMID: 23408771
citation: Kerr CE, Jones SR, Wan Q, Pritchett DL, Wasserman RH, Wexler A, Villanueva JJ, Shaw JR, Lazar SW, Kaptchuk TJ, Littenberg R, Hamalainen MS, Moore CI. Effects of mindfulness meditation training on anticipatory alpha modulation in primary somatosensory cortex. Brain Res Bull. 2011 May 30;85(3-4):96-103. doi: 10.1016/j.brainresbull.2011.03.026. Epub 2011 Apr 8.
PMID: 21501665
citation: Mehling WE, Wrubel J, Daubenmier JJ, Price CJ, Kerr CE, Silow T, Gopisetty V, Stewart AL. Body Awareness: a phenomenological inquiry into the common ground of mind-body therapies. Philos Ethics Humanit Med. 2011 Apr 7;6:6. doi: 10.1186/1747-5341-6-6.
PMID: 21473781
citation: Kerr CE, Shaw JR, Wasserman RH, Chen VW, Kanojia A, Bayer T, Kelley JM. Tactile acuity in experienced Tai Chi practitioners: evidence for use dependent plasticity as an effect of sensory-attentional training. Exp Brain Res. 2008 Jun;188(2):317-22. doi: 10.1007/s00221-008-1409-6. Epub 2008 May 30.
PMID: 18512052
citation: Lazar SW, Kerr CE, Wasserman RH, Gray JR, Greve DN, Treadway MT, McGarvey M, Quinn BT, Dusek JA, Benson H, Rauch SL, Moore CI, Fischl B. Meditation experience is associated with increased cortical thickness. Neuroreport. 2005 Nov 28;16(17):1893-7. doi: 10.1097/01.wnr.0000186598.66243.19.
PMID: 16272874
responsible party type: Principal Investigator
investigator affiliation: The Miriam Hospital
investigator full name: Ellen Flynn
investigator title: MD, Psychiatry
mesh term: Fatigue
sharing ipd: No
ipd description: No sharing plan anticipated.