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| Name | Class |
|---|---|
| Brown University | OTHER |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qigong | Experimental | 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. |
|
| Healthy Living (CHIP + Pre-Train) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qigong | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Fatigue (via FACIT-Fatigue scale) | Fatigue assessed via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire | Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Electrocardiogram (ECG) | Will be measured to calculate heart rate variability (HRV) | Measured at baseline (time 1) and after 10-week intervention (time 2) |
| Impedance Cardiography | Will be used to assess exercise related improvements in cardiovascular tone. |
| Measure | Description | Time Frame |
|---|---|---|
| Apple watches Heart Rate and Physical Steps Tracking | 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 | 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. |
Inclusion Criteria:
Exclusion Criteria:
Must be female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chloe S Zimmerman, BA | Contact | 401-863-6272 | chloe_zimmerman@brown.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ellen Flynn, MD | The Miriam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miriam Hospital Outpatient 146 West River Street | Recruiting | Providence | Rhode Island | 02904 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26106345 | Background | 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. | |
| 25750687 | Background | 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. |
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No sharing plan anticipated.
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D064906 | Qigong |
| D000081204 | Chromatin Immunoprecipitation Sequencing |
| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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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
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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.
|
| Healthy Living (CHIP + Pre-Train) | Behavioral | 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. |
|
| Measured at baseline (time 1) and after 10-week intervention (time 2) |
| Electroencephalography (EEG) | Will be used to assess changes in cortical brain waves (particularly alpha and beta rhythms) | Measured at baseline (time 1) and after 10-week intervention (time 2) |
| Tactile Acuity | 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 | Measured at baseline (time 1) and after 10-week intervention (time 2) |
| Electromyography (EMG) | A measure of muscle rhythms | Measured at baseline (time 1) and after 10-week intervention (time 2) |
| Precision Grip | 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 | Measured at baseline (time 1) and after 10-week intervention (time 2) |
| Electrodermal Activity (skin conductance) | to assess sympathetic tone | Measured at baseline (time 1) and after 10-week intervention (time 2) |
| Working memory capacity (WMC) | Assessed via the short-form O-SPAN computer-based task to assess overall memory impairments | Measured at baseline (time 1) and after 10-week intervention (time 2) |
| Mechanical lung function | to determine the impact of exercise and movement on overall lung function | Measured at baseline (time 1) and after 10-week intervention (time 2) |
| Inflammatory cytokines (eg Il-1, Il-6) collected via a blood draw | To measure the interaction between the brain measures of bodily awareness and the immune system | Measured at baseline (time 1) and after 10-week intervention (time 2) |
| Resting State Functional Magnetic Resonance Imaging (rs-fMRI) | Optional measure: To assess changes in functional connectivity associated with participation in the intervention | Measured at baseline (time 1) and after 10-week intervention (time 2) |
| Muscle Strength | Assessed via jamar hand dynamometers and back, leg, and arm dynamometers to assess changes in muscle tone associated with the classes | Measured at baseline (time 1) and after 10-week intervention (time 2) |
| 6 Minute Walk Test | Test of how far a participant can walk in six minutes to assess overall endurance | Measured at baseline (time 1) and after 10-week intervention (time 2) |
| Patient Health Questionnaire | Measure of anxiety and depression | Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) |
| Functional Assessment of cancer therapy-General (FACT-G) Questionnaire | Measure of physical, social, emotional, and functional well-being | Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) |
| Multidimensional Assessment of Interoceptive Awareness (MAIA) Questionnaire | Questionnaire to measure subjectively reported interoceptive and bodily awareness (including body-specific sensations, emotions, and cognitions) | Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) |
| Profile of Mood States (POMS) Questionnaire | To assess fatigue, vigor, and overall mood | Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) |
| Pittsburgh Sleep Quality Index (PSQI) | Measurement of sleep quality, habits, and patterns | Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) |
| Rand 36-Item Short Form Health Survey (SF-36) | Measurement of overall quality of life | Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) |
| Difficulties in Emotion Regulation Scale (DERS) | Measures multiple factors of emotional dysregulation | Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) |
| Fatigue Symptom Inventory (FSI) | Measures overall fatigue interfrerence | Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) |
| Perceived Stress Scale (PSS) Questionnaire | To assess changes in self-reported stress | Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) |
| Multidimensional Scale of Perceived Social Support (MSPSS) | Measure of self-reported social support | Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) |
| Unmitigated Communion Scale | A measure of a person's tendency to care for other's before themselves | Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) |
| Godin Leisure time Questionnaire | Measure of how much a person has been excising or relaxing | Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) |
| 24120430 | Background | 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. |
| 23692525 | Background | 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. |
| 23408771 | Background | 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. |
| 21501665 | Background | 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. |
| 21473781 | Background | 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. |
| 18512052 | Background | 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. |
| 16272874 | Background | 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. |
| 37204076 | Derived | Zimmerman CS, Temereanca S, Daniels D, Penner C, Cannonier T, Jones SR, Kerr C. A Randomized Controlled Pilot Trial Comparing Effects of Qigong and Exercise/Nutrition Training on Fatigue and Other Outcomes in Female Cancer Survivors. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231162584. doi: 10.1177/15347354231162584. |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
| D047369 | Chromatin Immunoprecipitation |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D059014 | High-Throughput Nucleotide Sequencing |
| D017421 | Sequence Analysis |
| D017422 | Sequence Analysis, DNA |
| D047468 | Immunoprecipitation |
| D007158 | Immunologic Techniques |