title: Qigong/Tai Chi Easy for fatigue in breast cancer survivors: Rationale and design of a randomized clinical trial.
abstract: Breast cancer survivors (BCSs) often report fatigue that persists for years following treatment. Despite a growing body of evidence for meditative movement practices to improve symptoms among BCSs, few studies have explored using Qigong/Tai Chi to reduce fatigue. Additionally, few have examined the biological mechanisms through which fatigue may be reduced using Qigong/Tai Chi.
  
  
  
  We will recruit 250 fatigued, post-menopausal women diagnosed with breast cancer (stage 0-III), between 6months and 5years past primary treatment and randomize to a standardized Qigong/Tai Chi Easy (QG/TCE) intervention, a "sham" Qigong group (movements without a focus on the breath and meditative state) (SQG), or an educational support (ES) group. The primary outcome (fatigue), secondary outcomes (anxiety, depression, sleep quality, cognitive function, physical activity), and a biomarker of HPA axis dysregulation (diurnal cortisol) will be assessed at baseline, post-intervention and 6months postintervention, and biomarkers of inflammation (IL1ra, IL6, TNFα and INFᵧ) at pre/post-intervention. We hypothesize that QG/TCE will reduce fatigue (and improve other symptoms associated with fatigue) in BCSs experiencing persistent cancer-related fatigue more than SQG and ES. Biomarkers will be examined for relationships to changes in fatigue.
  
  
  
  Findings from this study may reveal the effects of the unique mind-body aspects of QG/TCE on fatigue in BCSs with a complex design that separates the effects of low-intensity physical activity (SQG) and social support/attention (ES) from the primary intervention. Further, results will likely contribute greater understanding of the biological mechanisms of these practices related to improved symptoms among BCSs.
authors.affiliation: Arizona State University, School of Nutrition and Health Promotion, ASU PANW Program, Phoenix, AZ 85004, United States.
authors.forename: Linda
authors.initials: L
authors.lastname: Larkey
authors.affiliation: Arizona State University, School of Nutrition and Health Promotion, ASU PANW Program, Phoenix, AZ 85004, United States.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Huberty
authors.affiliation: Arizona State University, School of Nutrition and Health Promotion, ASU PANW Program, Phoenix, AZ 85004, United States. Electronic address: maja.pedersen@asu.edu.
authors.forename: Maja
authors.initials: M
authors.lastname: Pedersen
authors.affiliation: Arizona State University, School of Nutrition and Health Promotion, ASU PANW Program, Phoenix, AZ 85004, United States.
authors.forename: Karen
authors.initials: K
authors.lastname: Weihs
mesh_terms: D000367:Age Factors; D001943:Breast Neoplasms / Q000150:complications*; D000073116:Cancer Survivors; D015444:Exercise; D005221:Fatigue / Q000209:etiology* / Q000628:therapy*; D005260:Female; D006801:Humans; D018836:Inflammation Mediators / Q000378:metabolism; D008603:Mental Health; D010523:Peripheral Nervous System Diseases / Q000209:etiology / Q000628:therapy; D064906:Qigong / Q000379:methods*; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method; D012890:Sleep; D012944:Social Support; D026302:Tai Ji / Q000379:methods*; D015599:Trauma Severity Indices
chemical_list: D018836:Inflammation Mediators
keywords: Breast neoplasm; Fatigue; Qigong; Survivor symptoms; Tai Chi