Clinical trial NCT02690116: Effects of Meditative Movement (Qigong/Tai Chi Easy) on Fatigued Breast Cancer Survivors
Official title: Effects of Meditative Movement (Qigong/Tai Chi Easy) on Fatigued Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: Meditative movement
Breast cancer survivors
Qigong
Tai Chi Easy
Fatigue
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: University of Arizona
name: Mayo Clinic
First posted: 2016-02-24
Enrollment: 232
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Fatigue Symptom Inventory
timeFrame: Change from baseline fatigue to fatigue at 8 weeks and fatigue at 6 months.
Secondary outcomes:
measure: Profile of Mood States Short Form (POMS-SF)
timeFrame: Change from baseline anxiety and depression to anxiety and depression at 8 weeks and anxiety and depression at 6 months.
measure: Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG)
timeFrame: Change from baseline cognitive function to cognitive function at 8 weeks and cognitive function at 6 months.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline sleep quality to sleep quality at 8 weeks and sleep quality at 6 months
measure: Women's Health Initiative Brief Physical Activity Questionnaire (WHI-BPAQ)
timeFrame: Change from baseline physical activity (PA) to PA at 8 weeks and PA at 6 months
measure: Venipuncture for serum using MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel kits
timeFrame: Change from baseline Inflammatory biomarkers (IL-1β, IL-6,TNF-α; IFN-γ) to Inflammatory biomarkers at 8 weeks
measure: Diurnal salivary samples (enzyme assay)
timeFrame: Change from baseline salivary cortisol to salivary cortisol at 8 weeks
measure: ActiGraph GT3X activity monitor
timeFrame: Change from baseline objective physical activity to objective physical activity at 8 weeks and objective physical activity at 6 months
measure: ActiGraph GT3X activity monitor
timeFrame: Change from baseline objective sleep quality to objective sleep quality at 8 weeks and objective sleep quality at 6 months
Other outcomes:
measure: Functional Assessment of Cancer Therapy-Cognitive Function Neuropathy (FACT-COGNtx)
timeFrame: Change from baseline peripheral neuropathy to peripheral neuropathy at 8 weeks and peripheral neuropathy at 6 months
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Linda Larkey, PhD
role: PRINCIPAL_INVESTIGATOR
References: