Have you or your loved ones been diagnosed with cancer survivorship?
You may be eligible to participate in a cancer survivorship clinical trial.
Have you or your loved ones been diagnosed with cancer survivorship? You may be eligible to participate in a cancer survivorship clinical trial.
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Cancer Survivorship Clinical Trial in Providence RI
Have you or your loved ones been diagnosed with cancer survivorship?
You may be eligible to participate in a cancer survivorship clinical trial.
Have you or your loved ones been diagnosed with cancer survivorship? You may be eligible to participate in a cancer survivorship clinical trial.
Recruiting
Female
18 - 70
Years old
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.
Details for the study
Brief Title
The Vitality Project for Fatigued Female Cancer Survivors
Official Title
Testing the Effects of Movement Based Interventions on Brain-Body Mechanisms in Fatigued Cancer Survivors
Brief Summary
This parallel, randomized, non-inferiority trial will examine whether a ten week qigong<br /> intervention is not inferior to a ten week exercise-nutrition comparison group in reducing<br /> fatigue in cancer survivors. To build a more mechanistic understanding of physiological<br /> changes associated with fatigue reduction, it will secondly collect several different types<br /> of data to build an integrative brain-body model of vigor in cancer survivorship including:<br /><br /> 1. data related to neural correlates of body awareness: cortical EEG data measuring each<br /> subject's ability to use attention to control neurons in primary somatosensory cortex<br /> (replication of Kerr et al 2011 study in mindfulness), and resting state fMRI measures<br /> of insular connectivity with nodes of the default mode network and salience network<br /><br /> 2. data related to inflammation measured via inflammatory cytokines (e.g., interleukin-6<br /> and tnf-alpha)<br /><br /> 3. data related to cardiorespiratory functioning including cardiac impedance (ICG) and<br /> mechanical lung function<br /><br /> 4. data related to parasympathetic and sympathetic signaling between the nervous system and<br /> the rest of the periphery.
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.
Treatments and/or Procedures
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.
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.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Reduction in Fatigue (via FACIT-Fatigue scale)
Fatigue assessed via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire
Secondary
Muscle Strength
Assessed via jamar hand dynamometers and back, leg, and arm dynamometers to assess changes in muscle tone associated with the classes
Secondary
6 Minute Walk Test
Test of how far a participant can walk in six minutes to assess overall endurance
Secondary
Patient Health Questionnaire
Measure of anxiety and depression
Secondary
Functional Assessment of cancer therapy-General (FACT-G) Questionnaire
Measure of physical, social, emotional, and functional well-being
Secondary
Multidimensional Assessment of Interoceptive Awareness (MAIA) Questionnaire
Questionnaire to measure subjectively reported interoceptive and bodily awareness (including body-specific sensations, emotions, and cognitions)
Secondary
Profile of Mood States (POMS) Questionnaire
To assess fatigue, vigor, and overall mood
Secondary
Resting State Functional Magnetic Resonance Imaging (rs-fMRI)
Optional measure: To assess changes in functional connectivity associated with participation in the intervention
Secondary
Rand 36-Item Short Form Health Survey (SF-36)
Measurement of overall quality of life
Secondary
Difficulties in Emotion Regulation Scale (DERS)
Measures multiple factors of emotional dysregulation
Secondary
Fatigue Symptom Inventory (FSI)
Measures overall fatigue interfrerence
Secondary
Pittsburgh Sleep Quality Index (PSQI)
Measurement of sleep quality, habits, and patterns
Secondary
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
Secondary
Working memory capacity (WMC)
Assessed via the short-form O-SPAN computer-based task to assess overall memory impairments
Secondary
Mechanical lung function
to determine the impact of exercise and movement on overall lung function
Secondary
Electrocardiogram (ECG)
Will be measured to calculate heart rate variability (HRV)
Secondary
Impedance Cardiography
Will be used to assess exercise related improvements in cardiovascular tone.
Secondary
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
Secondary
Electromyography (EMG)
A measure of muscle rhythms
Secondary
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
Secondary
Electrodermal Activity (skin conductance)
to assess sympathetic tone
Secondary
Electroencephalography (EEG)
Will be used to assess changes in cortical brain waves (particularly alpha and beta rhythms)
Other
Multidimensional Scale of Perceived Social Support (MSPSS)
Measure of self-reported social support
Other
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
Other
Perceived Stress Scale (PSS) Questionnaire
To assess changes in self-reported stress
Other
Godin Leisure time Questionnaire
Measure of how much a person has been excising or relaxing
Other
Unmitigated Communion Scale
A measure of a person's tendency to care for other's before themselves
Study 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)