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Completed

NCT Number: NCT02690116

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

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.

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Key information

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Qigong/Tai Chi Easy

Other

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 Qigong

Other

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.

Educational Support

Other

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.

Primary outcomes

  1. Fatigue Symptom Inventory

    Time frame: Change from baseline fatigue to fatigue at 8 weeks and fatigue at 6 months.

    Fatigue

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. Diurnal salivary samples (enzyme assay)

    Time frame: Change from baseline salivary cortisol to salivary cortisol at 8 weeks

    Salivary cortisol

  7. 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

  8. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Mayo Clinic
  • University of Arizona

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 24, 2016
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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