TY - JOUR
T1 - Qigong/Tai Chi Easy for fatigue in breast cancer survivors
T2 - Rationale and design of a randomized clinical trial
AU - Larkey, Linda
AU - Huberty, Jennifer
AU - Pedersen, Maja
AU - Weihs, Karen
N1 - Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2016/9/1
Y1 - 2016/9/1
N2 - Introduction 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. Methods/study design We will recruit 250 fatigued, post-menopausal women diagnosed with breast cancer (stage 0-III), between 6 months and 5 years 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 6 months 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. Conclusions 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.
AB - Introduction 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. Methods/study design We will recruit 250 fatigued, post-menopausal women diagnosed with breast cancer (stage 0-III), between 6 months and 5 years 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 6 months 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. Conclusions 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.
KW - Breast neoplasm
KW - Fatigue
KW - Qigong
KW - Survivor symptoms
KW - Tai Chi
UR - http://www.scopus.com/inward/record.url?scp=84984876280&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84984876280&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2016.08.002
DO - 10.1016/j.cct.2016.08.002
M3 - Article
C2 - 27543065
AN - SCOPUS:84984876280
SN - 1551-7144
VL - 50
SP - 222
EP - 228
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
ER -