Effects of Meditative Movement (Qigong/Tai Chi Easy) on Fatigued Breast Cancer Survivors
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Qigong/Tai Chi Easy; Sham Qigong; Educational Support
Intervention type(s): Other; Other; Other
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Meditative movement; Breast cancer survivors; Qigong; Tai Chi Easy; Fatigue