TY - JOUR
T1 - Biobehavioral effects of Tai Chi Qigong in men with prostate cancer
T2 - Study design of a three-arm randomized clinical trial
AU - Kinney, Anita Y.
AU - Blair, Cindy K.
AU - Guest, Dolores D.
AU - Ani, Julianne K.
AU - Harding, Elizabeth M.
AU - Amorim, Fabiano
AU - Boyce, Tawny
AU - Rodman, Joseph
AU - Ford, C. Graham
AU - Schwartz, Matthew
AU - Rosenberg, Larissa
AU - Foran, Olivia
AU - Gardner, Jerry
AU - Lin, Yong
AU - Arap, Wadih
AU - Irwin, Michael R.
N1 - Funding Information:
We would like to acknowledge David Medrano for his assistance with project implementation and Dr. Ji-Hyun Lee for her input into the study design, including the statistical analysis plan and calculating statistical power and the sample size. We would also like to thank James McIntire, Sifu Dug Corpolongo, Curtis Hardison, Jerry LaSarre Gardner, and John Henry Moore for their contributions to the TCQ and BT intervention implementation and treatment fidelity. This work is supported by the National Cancer Institute of the National Institutes of Health [grant number R01CA203939 to A.Y.K and M.I.]; Biometrics Shared Resource and Biospecimen Repository and Histopathology Service of Rutgers Cancer Institute of New Jersey [NIH/NCI P30CA072720], the New Jersey Alliance for Clinical Translational Science; NJ ACTS, and the Behavioral and Population Science and Biostatistics shared resources of the UNM Comprehensive Cancer Center core grant [NIH/NCI P30 CA118100], and the University of New Mexico Clinical and Translational Science Center [UL1TR001449-04].
Funding Information:
We would like to acknowledge David Medrano for his assistance with project implementation and Dr. Ji-Hyun Lee for her input into the study design, including the statistical analysis plan and calculating statistical power and the sample size. We would also like to thank James McIntire, Sifu Dug Corpolongo, Curtis Hardison, Jerry LaSarre Gardner, and John Henry Moore for their contributions to the TCQ and BT intervention implementation and treatment fidelity. This work is supported by the National Cancer Institute of the National Institutes of Health [grant number R01CA203939 to A.Y.K and M.I.]; Biometrics Shared Resource and Biospecimen Repository and Histopathology Service of Rutgers Cancer Institute of New Jersey [ NIH/NCI P30CA072720 ], the New Jersey Alliance for Clinical Translational Science; NJ ACTS , and the Behavioral and Population Science and Biostatistics shared resources of the UNM Comprehensive Cancer Center core grant [ NIH/NCI P30 CA118100 ], and the University of New Mexico Clinical and Translational Science Center [ UL1TR001449-04 ].
Publisher Copyright:
© 2019 The Authors
PY - 2019/12
Y1 - 2019/12
N2 - Fatigue is often one of the most commonly reported symptoms in prostate cancer survivors, but it is also one of the least understood cancer-related symptoms. Fatigue is associated with psychological distress, disruptions in sleep quality, and impairments in health-related quality of life. Moreover, inflammatory processes and changes related to the hypothalamic-pituitary-adrenal (HPA) axis and/or autonomic nervous system may also play a role in cancer-related fatigue. Thus, effective treatments for fatigue in prostate cancer survivors represent a current unmet need. Prior research has shown that Tai Chi Qigong, a mind-body exercise intervention, can improve physical and emotional health. Herein, we describe the protocol of the ongoing 3-arm randomized controlled Health Empowerment & Recovery Outcomes (HERO) clincal trial. One hundred sixty-six prostate cancer survivors with fatigue are randomized to a modified Tai Chi Qigong intervention (TCQ), intensity-matched body training intervention (BT), or usual care (UC) condition. Guided by biopsychosocial and psychoneuroimmunology models, we propose that TCQ, as compared to BT or UC will: i) reduce fatigue (primary outcome) in prostate cancer survivors; ii) reduce inflammation; and iii) regulate the expression of genes from two major functional clusters: a) inflammation, vasodilation and metabolite sensing and b) energy and adrenergic activation. Assessments are conducted at baseline, the 6-week midpoint of the intervention, and 1 week, 3 months, and 12 months post-intervention. If our findings show that TCQ promotes recovery from prostate cancer and its treatment, this type of intervention can be integrated into survivorship care plans as the standard of care. The study's findings will also provide novel information about underlying biobehavioral mechanisms of cancer-related fatigue. Trial registration number: NCT03326713; clinicaltrials.gov.
AB - Fatigue is often one of the most commonly reported symptoms in prostate cancer survivors, but it is also one of the least understood cancer-related symptoms. Fatigue is associated with psychological distress, disruptions in sleep quality, and impairments in health-related quality of life. Moreover, inflammatory processes and changes related to the hypothalamic-pituitary-adrenal (HPA) axis and/or autonomic nervous system may also play a role in cancer-related fatigue. Thus, effective treatments for fatigue in prostate cancer survivors represent a current unmet need. Prior research has shown that Tai Chi Qigong, a mind-body exercise intervention, can improve physical and emotional health. Herein, we describe the protocol of the ongoing 3-arm randomized controlled Health Empowerment & Recovery Outcomes (HERO) clincal trial. One hundred sixty-six prostate cancer survivors with fatigue are randomized to a modified Tai Chi Qigong intervention (TCQ), intensity-matched body training intervention (BT), or usual care (UC) condition. Guided by biopsychosocial and psychoneuroimmunology models, we propose that TCQ, as compared to BT or UC will: i) reduce fatigue (primary outcome) in prostate cancer survivors; ii) reduce inflammation; and iii) regulate the expression of genes from two major functional clusters: a) inflammation, vasodilation and metabolite sensing and b) energy and adrenergic activation. Assessments are conducted at baseline, the 6-week midpoint of the intervention, and 1 week, 3 months, and 12 months post-intervention. If our findings show that TCQ promotes recovery from prostate cancer and its treatment, this type of intervention can be integrated into survivorship care plans as the standard of care. The study's findings will also provide novel information about underlying biobehavioral mechanisms of cancer-related fatigue. Trial registration number: NCT03326713; clinicaltrials.gov.
KW - Cancer survivors
KW - Clinical trial
KW - Prostate cancer
KW - Qigong
KW - Tai chi
UR - http://www.scopus.com/inward/record.url?scp=85072197654&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85072197654&partnerID=8YFLogxK
U2 - 10.1016/j.conctc.2019.100431
DO - 10.1016/j.conctc.2019.100431
M3 - Article
AN - SCOPUS:85072197654
VL - 16
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
SN - 2451-8654
M1 - 100431
ER -