FatigueNCT03259438
The Vitality Project for Fatigued Female Cancer Survivors
A study testing Qigong and Healthy Living (CHIP + Pre-Train) in people with Fatigue and Cancer Survivorship, run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Fatigue, Cancer Survivorship
- What is being tested?
- Qigong and Healthy Living (CHIP + Pre-Train)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2017to 30 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- Tobacco use
- Pregnancy
- Ingestion of caffeine or cocoa products less than two hours from data collection
- Inability to participate in gentle exercises (like pilates)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Miriam Hospital Outpatient 146 West River Street
Providence, Rhode Island, 02904
Ellen Flynn, MD, 401-793-7020, eflynn@lifespan.org
Susan Martin, LDN, IBCLC, 401-793-7822, smartin8@lifespan.org
About this study
Official title: Testing the Effects of Movement Based Interventions on Brain-Body Mechanisms in Fatigued Cancer Survivors
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:
- 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
- data related to inflammation measured via inflammatory cytokines (e.g., interleukin-6 and tnf-alpha)
- data related to cardiorespiratory functioning including cardiac impedance (ICG) and mechanical lung function
- data related to parasympathetic and sympathetic signaling between the nervous system and the rest of the periphery.
Read the 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.
- Conditions
- Fatigue, Cancer Survivorship
- Being tested
- Qigong, Healthy Living (CHIP + Pre-Train)
- Keywords
- Qigong, Comprehensive Health Improvement Program (CHIP), Pre-Train Injury Prevention Program, Cancer Related Fatigue, Cancer Survivorship, Inflammation, Flowmetry, Corticomuscular coherence, Heart Rate Variability, Neuroimmune Interactions, Complex Systems Analysis, Female
- Medical subject headings
- Fatigue, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QigongBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Qigong |
| 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. Receives: Behavioral: Healthy Living (CHIP + Pre-Train) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Fatigue (via FACIT-Fatigue scale)
Fatigue assessed via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire
Measured: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Secondary outcomes (21)
Electrocardiogram (ECG)
Will be measured to calculate heart rate variability (HRV)
Measured: 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.
Measured: 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: 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: Measured at baseline (time 1) and after 10-week intervention (time 2)
Electromyography (EMG)
A measure of muscle rhythms
Measured: 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: Measured at baseline (time 1) and after 10-week intervention (time 2)
Electrodermal Activity (skin conductance)
to assess sympathetic tone
Measured: 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: 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: 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: 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: 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: 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: Measured at baseline (time 1) and after 10-week intervention (time 2)
Patient Health Questionnaire
Measure of anxiety and depression
Measured: 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: 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: 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: 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: 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: 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: 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: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start24 Jul 2017
- Primary completion20 Dec 2017 (estimated)
- Study completion30 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Principal investigator, Ellen Flynn, The Miriam Hospital
- Investigators
- Ellen Flynn, MD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259438
- Sponsor's protocol ID
- MiriamH 1040485
- Status last verified
- Aug 2017
- First submitted
- 19 Jul 2017
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing plan anticipated.
Publications
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.
PubMed 26106345Desbordes 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.
PubMed 25750687Wells 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.
PubMed 24120430Daubenmier 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.
PubMed 23692525Kerr 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.
PubMed 23408771Kerr 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.
PubMed 21501665Mehling 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.
PubMed 21473781Kerr 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.
PubMed 18512052Lazar 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.
PubMed 16272874Zimmerman 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.
PubMed 37204076
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effects of Movement Based Interventions on Brain-Body Mechanisms in Fatigued Cancer Survivors
- ClinicalTrials.gov ID
- NCT03259438
- Acronym / sponsor ID
- MiriamH 1040485
- Conditions
- Fatigue, Cancer Survivorship
- Keywords
- Qigong, Comprehensive Health Improvement Program (CHIP), Pre-Train Injury Prevention Program, Cancer Related Fatigue, Cancer Survivorship, Inflammation, Flowmetry, Corticomuscular coherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 20 Dec 2017 (estimated)
- Study completion
- 30 Jan 2018 (estimated)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- data related to inflammation measured via inflammatory cytokines (e.g., interleukin-6 and tnf-alpha)
- data related to cardiorespiratory functioning including cardiac impedance (ICG) and mechanical lung function
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Qigong | Experimental | Behavioral: QigongThis 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 | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QigongQigong 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. | Behavioural | Qigong |
| 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. | Behavioural | Healthy Living (CHIP + Pre-Train) |
Primary outcome
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)
Fatigue assessed via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire
21 secondary outcomes
Electrocardiogram (ECG)
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
Impedance Cardiography
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
Electroencephalography (EEG)
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
Tactile Acuity
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
Electromyography (EMG)
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
Precision Grip
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
Electrodermal Activity (skin conductance)
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
Working memory capacity (WMC)
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
Mechanical 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
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
Resting State Functional Magnetic Resonance Imaging (rs-fMRI)
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
Muscle Strength
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
6 Minute Walk Test
Time frame: Measured at baseline (time 1) and after 10-week intervention (time 2)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Background: PubMed 26106345Farb 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.
- Background: PubMed 25750687Desbordes 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.
- Background: PubMed 24120430Wells 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.
- Background: PubMed 23692525Daubenmier 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.
- Background: PubMed 23408771Kerr 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.
- Background: PubMed 21501665Kerr 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.
- Background: PubMed 21473781Mehling 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.
- Background: PubMed 18512052Kerr 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.
- Background: PubMed 16272874Lazar 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.
- Derived from this study: PubMed 37204076Zimmerman 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.
- Individual participant dataSharing planned: No. No sharing plan anticipated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Flynn, MD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong and Healthy Living (CHIP + Pre-Train) in people with Fatigue and Cancer Survivorship, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chloe S Zimmerman, BA (401-863-6272, chloe_zimmerman@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03259438, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.