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The Vitality Project for Fatigued Female Cancer Survivors

Primary Purpose

Fatigue, Cancer Survivorship

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Qigong

Healthy Living (CHIP + Pre-Train)

About this trial

This is an interventional treatment trial for Fatigue focused on measuring 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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Miriam Hospital Outpatient 146 West River StreetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Qigong

Healthy Living (CHIP + Pre-Train)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Reduction in Fatigue (via FACIT-Fatigue scale)

Fatigue assessed via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire

Secondary Outcome Measures

Electrocardiogram (ECG)

Will be measured to calculate heart rate variability (HRV)

Impedance Cardiography

Will be used to assess exercise related improvements in cardiovascular tone.

Electroencephalography (EEG)

Will be used to assess changes in cortical brain waves (particularly alpha and beta rhythms)

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

Electromyography (EMG)

A measure of muscle rhythms

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

Electrodermal Activity (skin conductance)

to assess sympathetic tone

Working memory capacity (WMC)

Assessed via the short-form O-SPAN computer-based task to assess overall memory impairments

Mechanical lung function

to determine the impact of exercise and movement on overall lung function

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

Resting State Functional Magnetic Resonance Imaging (rs-fMRI)

Optional measure: To assess changes in functional connectivity associated with participation in the intervention

Muscle Strength

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

Test of how far a participant can walk in six minutes to assess overall endurance

Patient Health Questionnaire

Measure of anxiety and depression

Functional Assessment of cancer therapy-General (FACT-G) Questionnaire

Measure of physical, social, emotional, and functional well-being

Multidimensional Assessment of Interoceptive Awareness (MAIA) Questionnaire

Questionnaire to measure subjectively reported interoceptive and bodily awareness (including body-specific sensations, emotions, and cognitions)

Profile of Mood States (POMS) Questionnaire

To assess fatigue, vigor, and overall mood

Pittsburgh Sleep Quality Index (PSQI)

Measurement of sleep quality, habits, and patterns

Rand 36-Item Short Form Health Survey (SF-36)

Measurement of overall quality of life

Difficulties in Emotion Regulation Scale (DERS)

Measures multiple factors of emotional dysregulation

Fatigue Symptom Inventory (FSI)

Measures overall fatigue interfrerence

Full Information

NCT ID

NCT03259438

First Posted

July 19, 2017

Last Updated

August 21, 2017

Sponsor

The Miriam Hospital

Collaborators

Brown University

1. Study Identification

Unique Protocol Identification Number

NCT03259438

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 24, 2017 (Actual)

Primary Completion Date

December 20, 2017 (Anticipated)

Study Completion Date

January 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Miriam Hospital

Collaborators

Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatigue, Cancer Survivorship

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

InvestigatorOutcomes Assessor

Masking Description

Participants will not find out what interventional group they are placed in (qigong vs. healthy living) until after they have completed their first testing session. Pre intervention data collection and post intervention data analysis will be completely masked.

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Qigong

Arm Type

Experimental

Arm Description

Arm Title

Healthy Living (CHIP + Pre-Train)

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Qigong

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Healthy Living (CHIP + Pre-Train)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Reduction in Fatigue (via FACIT-Fatigue scale)

Description

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)

Secondary Outcome Measure Information:

Title

Electrocardiogram (ECG)

Description

Will be measured to calculate heart rate variability (HRV)

Time Frame