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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02690116.
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.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationArizona State University