The Vitality Project for Fatigued Female Cancer Survivors
- Conditions
- FatigueCancer Survivorship
- Interventions
- Behavioral: QigongBehavioral: Healthy Living (CHIP + Pre-Train)
- Registration Number
- NCT03259438
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 75
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Qigong 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. Healthy Living (CHIP + Pre-Train) 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.
- Primary Outcome Measures
Name Time Method Reduction in Fatigue (via FACIT-Fatigue scale) 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
Name Time Method Electrocardiogram (ECG) Measured at baseline (time 1) and after 10-week intervention (time 2) Will be measured to calculate heart rate variability (HRV)
Impedance Cardiography Measured at baseline (time 1) and after 10-week intervention (time 2) Will be used to assess exercise related improvements in cardiovascular tone.
Electroencephalography (EEG) 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)
Tactile Acuity 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
Electromyography (EMG) Measured at baseline (time 1) and after 10-week intervention (time 2) A measure of muscle rhythms
Precision Grip 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
Electrodermal Activity (skin conductance) Measured at baseline (time 1) and after 10-week intervention (time 2) to assess sympathetic tone
Resting State Functional Magnetic Resonance Imaging (rs-fMRI) 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
Muscle Strength 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
6 Minute Walk Test 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
Working memory capacity (WMC) 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
Mechanical lung function Measured at baseline (time 1) and after 10-week intervention (time 2) to determine the impact of exercise and movement on overall lung function
Inflammatory cytokines (eg Il-1, Il-6) collected via a blood draw 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
Patient Health Questionnaire 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
Functional Assessment of cancer therapy-General (FACT-G) Questionnaire 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
Multidimensional Assessment of Interoceptive Awareness (MAIA) Questionnaire 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)
Profile of Mood States (POMS) Questionnaire 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
Pittsburgh Sleep Quality Index (PSQI) 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
Rand 36-Item Short Form Health Survey (SF-36) 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
Difficulties in Emotion Regulation Scale (DERS) 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
Fatigue Symptom Inventory (FSI) 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
Trial Locations
- Locations (1)
Miriam Hospital Outpatient 146 West River Street
🇺🇸Providence, Rhode Island, United States