Effects of Meditative Movement (Qigong/Tai Chi Easy) on Fatigued Breast Cancer Survivors

June 4, 2021 updated by: Arizona State University
The purpose of this study is to test whether Meditative Movement (based on a standardized and tested Qigong/Tai Chi Easy protocol) is more efficacious for improving fatigue and other symptoms in women after treatment for breast cancer than (a) a non-meditative "sham" Qigong active intervention and (b) an inactive education / support group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with breast cancer often report fatigue and other associated symptoms that persist for months, even years, after treatment ends. In a recent pilot study of Qigong/Tai Chi Easy (QG/TCE, a low-intensity form of Meditative Movement), fatigued breast cancer survivors experienced greater improvements in fatigue (medium effect size, .56); compared to a "sham" Qigong control intervention (also low-intensity activity). Trends for improvement compared to control were found for sleep quality and depression. Recruitment for the single-site implementation was steady, and feasible. To build upon the promise of this pilot study, and to further test intervention components that may elucidate what aspects of the intervention have the most impact, a three-group, randomized trial will be undertaken to test effects of an 8-week QG/TCE intervention on fatigue and other symptoms at the end of 8 weeks, and 24 weeks post-intervention. 246 (attrition to 210) women who are 6 months to 10 years past treatment for Stage 0- III breast cancer, aged 45-75, and post-menopausal, will be randomized into one of three study arms. Two comparison groups will be used, an educational support (ES) group control and an active sham Qigong (SQG) group with movements that are similar to and with the same level of physical activity intensity as QG/TCE, but without the focus on the breath and meditative state. These treatments allow for separation of effects associated with gentle exercise alone (controlled in SQG) and education/social support alone without any exercise (controlled in ES) relative to the mind-body practice of QG/TCE, to distinguish unique effects of the meditative and breath foci. The study will be implemented in two sites in a large, metropolitan area, including one low-income hospital (and catchment neighborhood) with larger numbers of Latina survivors where our research team has extensive community connections and cultural experience implementing exercise and meditative movement programs. Psychometrics and biomarkers related to symptoms before and after the interventions will be examined to further our understanding of the mechanisms associated with effects of QG/TCE, as distinct from ES and SQG.

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Arizona State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosed with breast cancer, stage 0-III
  • Between 6 months and 10 years past primary treatment
  • Post-menopausal
  • Experiencing fatigue (scoring < 75 on "Vitality" scale of Short Form (SF)-36)
  • English-speaking or Spanish-speaking

Exclusion Criteria:

  • Women who are unable to stand for 10-minute segments
  • Women who have had substantial experience with mind-body practices that blend movement with mindfulness/breathing techniques, such as Yoga, Tai Chi, or Qigong
  • Women who work night shifts (fatigue-related factor)
  • Restless leg syndrome (fatigue-related factor)
  • Hypothyroidism (fatigue-related factor)
  • Currently diagnosed with anemia (fatigue-related factor)
  • Uncontrolled diabetes (fatigue-related factor)
  • Major severe clinical depression (fatigue-related factor)
  • Use of antihistamine, cyclosporins, corticosteroids, sleeping aids
  • Regular use of alcohol (more than 2 drinks per day)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Qigong/Tai Chi Easy
The Qigong/Tai Chi Easy (QG/TCE) intervention has been standardized, manualized, and has a formal training program for instructors from the Institute of Integral Qigong and Tai Chi (IIQTC).
Other: Qigong/Tai Chi Easy
Classes will be at two different times of day (to accommodate working and non-working participants). Participants will attend one 60 minute class per week for the 8 weeks, with a recommended home practice time of 2 1/2 hours each week.
Sham Comparator: Sham Qigong
This active control group uses a gentle movement intervention, with similar types of movements with the same energy expenditure, but without the meditative states and breath focus as QG/TCE (validated in the pilot study using the Meditative Movement Inventory).
Other: Sham Qigong
Classes will be at two different times of day (to accommodate working and non-working participants). Participants will attend one 60 minute class per week for the 8 weeks, with a recommended home practice time of 2 1/2 hours each week.
Active Comparator: Educational Support
The Recovery Support Group will consist of a classroom-style intervention, designed to educate, engage interaction, and maintain participation and attention over 8 weeks. This group will include readings/discussions specific to breast cancer, and social interaction facilitation.
Other: Educational Support
Class times and at-home readings correspond to dose set for the QG/TCE and SQG class times and home practice. Participants will attend one 60-minute class per week for the 8 weeks, with a recommended home practice time (reading, workbook completion) of 2 1/2 hours each week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Symptom Inventory
Time Frame: Change from baseline fatigue to fatigue at 8 weeks and fatigue at 6 months.
Fatigue
Change from baseline fatigue to fatigue at 8 weeks and fatigue at 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Profile of Mood States Short Form (POMS-SF)
Time Frame: Change from baseline anxiety and depression to anxiety and depression at 8 weeks and anxiety and depression at 6 months.
Anxiety and depression
Change from baseline anxiety and depression to anxiety and depression at 8 weeks and anxiety and depression at 6 months.
Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG)
Time Frame: Change from baseline cognitive function to cognitive function at 8 weeks and cognitive function at 6 months.
Cognitive function
Change from baseline cognitive function to cognitive function at 8 weeks and cognitive function at 6 months.
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Change from baseline sleep quality to sleep quality at 8 weeks and sleep quality at 6 months
Sleep quality
Change from baseline sleep quality to sleep quality at 8 weeks and sleep quality at 6 months
Women's Health Initiative Brief Physical Activity Questionnaire (WHI-BPAQ)
Time Frame: Change from baseline physical activity (PA) to PA at 8 weeks and PA at 6 months
Physical activity
Change from baseline physical activity (PA) to PA at 8 weeks and PA at 6 months
Venipuncture for serum using MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel kits
Time Frame: Change from baseline Inflammatory biomarkers (IL-1β, IL-6,TNF-α; IFN-γ) to Inflammatory biomarkers at 8 weeks
Inflammatory biomarkers (IL-1β, IL-6,TNF-α; IFN-γ)
Change from baseline Inflammatory biomarkers (IL-1β, IL-6,TNF-α; IFN-γ) to Inflammatory biomarkers at 8 weeks
Diurnal salivary samples (enzyme assay)
Time Frame: Change from baseline salivary cortisol to salivary cortisol at 8 weeks
Salivary cortisol
Change from baseline salivary cortisol to salivary cortisol at 8 weeks
ActiGraph GT3X activity monitor
Time Frame: Change from baseline objective physical activity to objective physical activity at 8 weeks and objective physical activity at 6 months
Objective measurement of physical activity
Change from baseline objective physical activity to objective physical activity at 8 weeks and objective physical activity at 6 months
ActiGraph GT3X activity monitor
Time Frame: Change from baseline objective sleep quality to objective sleep quality at 8 weeks and objective sleep quality at 6 months
Objective measurement of sleep quality
Change from baseline objective sleep quality to objective sleep quality at 8 weeks and objective sleep quality at 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy-Cognitive Function Neuropathy (FACT-COGNtx)
Time Frame: Change from baseline peripheral neuropathy to peripheral neuropathy at 8 weeks and peripheral neuropathy at 6 months
Peripheral Neuropathy
Change from baseline peripheral neuropathy to peripheral neuropathy at 8 weeks and peripheral neuropathy at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arizona State University

Collaborators

Mayo Clinic
University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

February 19, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01CA182901-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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