An interventional study of Qigong and Healthy Living (CHIP + Pre-Train) in Fatigue and Cancer Survivorship, sponsored by The Miriam Hospital. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-08-23.
Sponsored by The Miriam Hospital · Not applicable, Interventional, and Treatment
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.
2,229 studies on the registry are indexed under Fatigue; 426 are open to participants now.
This study's planned enrollment of 75 is above the median of 54 across 1,757 interventional studies indexed under Fatigue.
Browse Fatigue studies →The Miriam Hospital is the lead sponsor of 182 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
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.
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.
Reduction in Fatigue (via FACIT-Fatigue scale)
Fatigue assessed via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Electrocardiogram (ECG)
Will be measured to calculate heart rate variability (HRV)
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
Electromyography (EMG)
A measure of muscle rhythms
Time frame: 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
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
Electrodermal Activity (skin conductance)
to assess sympathetic tone
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
Patient Health Questionnaire
Measure of anxiety and depression
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
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
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.
Perceived Stress Scale (PSS) Questionnaire
To assess changes in self-reported stress
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Plan to share: No — No sharing plan anticipated.
Started Jul 2017 (actual). Primary completion is estimated for Dec 2017, 4 months after the start.
Of 936 non-industry interventional studies with no phase under Fatigue, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 4 months is below that.
Counting every sponsor, half of 989 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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