The Vitality Project for Fatigued Female Cancer Survivors

NCT03259438 | Unknown

• 1 other identifier: MiriamH 1040485
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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. 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. 2.data related to inflammation measured via inflammatory cytokines (e.g., interleukin-6 and tnf-alpha)
3. 3.data related to cardiorespiratory functioning including cardiac impedance (ICG) and mechanical lung function
4. 4.data related to parasympathetic and sympathetic signaling between the nervous system and the rest of the periphery.

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; Heart Rate Variability; Neuroimmune Interactions; Complex Systems Analysis; Female

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Electrocardiogram (ECG)

  Measured at baseline (time 1) and after 10-week intervention (time 2)

• Impedance Cardiography

  Measured at baseline (time 1) and after 10-week intervention (time 2)

• Electroencephalography (EEG)

  Measured at baseline (time 1) and after 10-week intervention (time 2)

• Tactile Acuity

  Measured at baseline (time 1) and after 10-week intervention (time 2)

• Electromyography (EMG)

  Measured at baseline (time 1) and after 10-week intervention (time 2)

Other Outcomes (5)

• Apple watches Heart Rate and Physical Steps Tracking

  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

  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)

  Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)

Study Arms (2)

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.

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.

Behavioral: Healthy Living (CHIP + Pre-Train)

Interventions

Qigong BEHAVIORAL

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.

Qigong

Healthy Living (CHIP + Pre-Train) BEHAVIORAL

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.

Healthy Living (CHIP + Pre-Train)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Must be female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Miriam Hospital: lead
• Brown University: collaborator

Study Sites (1)

Miriam Hospital Outpatient 146 West River Street

Providence, Rhode Island, 02904, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 26106345 BACKGROUND

• 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.

  PMID: 25750687 BACKGROUND

• 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.

  PMID: 24120430 BACKGROUND

• 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.

  PMID: 23692525 BACKGROUND

• 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.

  PMID: 23408771 BACKGROUND

• 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.

  PMID: 21501665 BACKGROUND

• 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.

  PMID: 21473781 BACKGROUND

• 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.

  PMID: 18512052 BACKGROUND

• 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.

  PMID: 16272874 BACKGROUND

• Zimmerman 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.

  PMID: 37204076 DERIVED

MeSH Terms

Conditions

Fatigue; Inflammation

Interventions

Qigong; Chromatin Immunoprecipitation Sequencing

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Breathing Exercises; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Chromatin Immunoprecipitation; Genetic Techniques; Investigative Techniques; High-Throughput Nucleotide Sequencing; Sequence Analysis; Sequence Analysis, DNA; Immunoprecipitation; Immunologic Techniques

Study Officials

• Ellen Flynn, MD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloe S Zimmerman, BA

CONTACT

401-863-6272; chloe_zimmerman@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Psychiatry

Model Details: 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

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: August 23, 2017
• Study Start: July 24, 2017
• Primary Completion: December 20, 2017
• Study Completion: January 30, 2018
• Last Updated: August 23, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)