Evaluating Qigong as a Clinical Intervention for Cancer Survivors' Fatigue

NCT02845492 | Unknown

• 1 other identifier: MiriamH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares Qigong movement-based meditation exercise with a healthy living exercise-wellness course. There are two primary goals of this research:

1. 1.Evaluate and compare physiological mechanisms underlying the two wellness-exercise interventions with the specific goal of understanding the physiology of Qigong.
2. 2.Compare effect sizes of the two interventions in decreasing fatigue in order to plan for a larger clinical trial.

Conditions

Fatigue

Keywords

Exercise; Qigong; Mind-Body; Fatigue; Cancer; EEG; HRV

Outcome Measures

Primary Outcomes (1)

• Fatigue Symptom Inventory Questionnaire

  Questions about daily experience of fatigue

  Change from baseline to 10 weeks

Secondary Outcomes (4)

• EEG meditative brain measures,

  at baseline and at 10 weeks

• Self-reported Vitality (a component of the Medical Outcomes Short-Form 36)

  at baseline and 10 weeks

• Heart Rate Variability (HRV)

  at baseline and 10 weeks

• Inflammatory cytokines

  at baseline and 10 weeks

Other Outcomes (2)

• Difficulties in emotion regulation self-report scale (DERS)

  at baseline and 10 weeks

• Handgrip strength

  at baseline and 10 weeks

Study Arms (2)

Qigong intervention

EXPERIMENTAL

Qigong meditative exercise intervention meets three times a week for 10 weeks. The qigong group (n=30) will meet at the Women's Medicine Collaborative, Miriam Hospital (146 W. River St., Providence, RI) for Qigong classes. The lesson will be taught by a validated Qi Gong master with over forty years of experience and the interventional protocol will be validated. Two and a half hours of weekly outside personal practice will also be required of participants.

Other: Qigong

CHIP healthy wellness-exercise class

ACTIVE COMPARATOR

The Complete Health Improvement Program is a validated set of weekly classes designed to promote gentle exercise and wellness related activities in a supportive group setting led by an experienced trainer.

Other: Complete Health Improvement Program (CHIP)

Interventions

Qigong OTHER

Qigong is a mind-body exercise based around gentle exercise and the cultivation of a meditative focus on bodily sensations

Also known as: Meditative Exercise Therapy

Qigong intervention

Complete Health Improvement Program (CHIP) OTHER

The CHIP program is a validated weekly wellness and exercise program designed to promote health and wellbeing.

Also known as: Wellness-Exercise Program

CHIP healthy wellness-exercise class

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients
• Aged 18-70 years
• Self-report of fatigue =/\> 3/10 on fatigue interference scale
• Have been diagnosed and completed treatment for cancer (with surgery or radiation or chemotherapy)
• no surgery, radiation or chemotherapy received in the past 8 weeks (ongoing treatment with Herceptin \[trastuzumab\] or other adjuvant therapies is permitted)
• Currently cancer-free
• Have a primary care or other physician
• Ability to understand English
• Willingness to have blood drawn, have an EEG taken and complete questionnaires
• 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 practice.

You may not qualify if:

• History or current diagnosis of medical or psychiatric disorder that would interfere with ability to participate in wellness classes or in scientific assessment sessions (e.g., rheumatoid arthritis, diabetes, major psychiatric disorder, connective tissue disorder)
• Body Mass Index (BMI) \> 31
• Active alcohol or drug abuse
• Tobacco use
• Pregnancy
• Regular daily use of anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs, (does not apply to common use of daily "baby aspirin" as daily prophylactic cardiovascular treatment)
• Resting systolic blood pressure of less than 90 or greater than 160 and resting diastolic blood pressure of greater than 110.
• Ingestion of caffeine or cocoa products less than two hours from data collection
• Contraindication to regular physical activity participation
• Already engaging in \>60 min of vigorous physical activity per week for the prior month
• Weekly practice of yoga, Tai Chi, Qigong, or meditation since the diagnosis of cancer
• Peripheral neuropathy

Sponsors & Collaborators

• The Miriam Hospital: lead
• Brown University: collaborator

Study Sites (1)

Miriam Hospital

Providence, Rhode Island, 02904, United States

RECRUITING

Related Publications (2)

• 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

• Schmalzl L, Kerr CE. Editorial: Neural Mechanisms Underlying Movement-Based Embodied Contemplative Practices. Front Hum Neurosci. 2016 Apr 26;10:169. doi: 10.3389/fnhum.2016.00169. eCollection 2016. No abstract available.

  PMID: 27199700 BACKGROUND

MeSH Terms

Conditions

Fatigue; Motor Activity; Neoplasms

Interventions

Qigong

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Breathing Exercises; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Catherine Kerr, PhD

  Women's Medicine Collaborative, Miriam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloe Zimmerman, BA

CONTACT

4018636272; chloe_zimmerman@brown.edu

Brendan Cullen, BA

CONTACT

4018636272; Brendan_Cullen@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Family Medicine

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 27, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 1, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)