The Vitality Project for Fatigued Female Cancer Survivors

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:

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.

Study Overview

• Status: Unknown
• Conditions: Fatigue; Cancer Survivorship
• Intervention / Treatment: Behavioral: Qigong; Behavioral: Healthy Living (CHIP + Pre-Train)

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 Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chloe S Zimmerman, BA; Phone Number: 401-863-6272; Email: chloe_zimmerman@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Recruiting
      • Miriam Hospital Outpatient 146 West River Street
      • Contact: Ellen Flynn, MD; Phone Number: 401-793-7020; Email: eflynn@lifespan.org
      • Contact: Susan Martin, LDN, IBCLC; Phone Number: 401-793-7822; Email: smartin8@lifespan.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: 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.
ACTIVE_COMPARATOR: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Other Outcome Measures

Outcome Measure	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.
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)

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: Brown University
• Investigators: Principal Investigator: Ellen Flynn, MD, The Miriam Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 24, 2017
• Primary Completion (ANTICIPATED): December 20, 2017
• Study Completion (ANTICIPATED): January 30, 2018

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (ACTUAL): August 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2017
• Last Update Submitted That Met QC Criteria: August 21, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Inflammation; Heart Rate Variability; Female; Qigong; Cancer Survivorship; Corticomuscular coherence; Cancer Related Fatigue; Comprehensive Health Improvement Program (CHIP); Pre-Train Injury Prevention Program; Flowmetry; Neuroimmune Interactions; Complex Systems Analysis
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: MiriamH 1040485

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing plan anticipated.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No