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临床试验/NCT02690116
NCT02690116已完成不适用

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

Arizona State University2 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
232
试验地点
2
主要终点
Fatigue Symptom Inventory

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Fatigue Symptom Inventory

时间窗: Change from baseline fatigue to fatigue at 8 weeks and fatigue at 6 months.

Fatigue

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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