Biobehavioral effects of Tai Chi Qigong in men with prostate cancer: Study design of a three-arm randomized clinical trial.

Author: Kinney AY1,2, Blair CK3,4, Guest DD4, Ani JK2, Harding EM4, Amorim F5, Boyce T4, Rodman J4, Ford CG4,6, Schwartz M3,4, Rosenberg L2, Foran O2, Gardner J7, Lin Y1,2, Arap W8,9, Irwin MR10,11
1Department of Biostatistics and Epidemiology, School of Public Health, Rutgers University, Piscataway, NJ, USA.
2Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
3Department of Internal Medicine, University of New Mexico, Albuquerque, NM, USA.
4University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA.
5Department of Health, Exercise and Sports Sciences, University of New Mexico, Albuquerque, NM, USA.
6Department of Psychology, University of New Mexico, Albuquerque, NM, USA.
7Department of Theatre, University of Utah, Salt Lake City, UT, USA.
8Division of Hematology/Oncology, Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.
9Rutgers Cancer Institute of New Jersey, Newark, NJ, USA.
10Cousins Center for Psychoneuroimmunology, Semel Institute for Neurosciences, University of California Los Angeles, California, USA.
11Department of Psychiatry, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
Conference/Journal: Contemp Clin Trials Commun.
Date published: 2019 Aug 21
Other: Volume ID: 16 , Pages: 100431 , Special Notes: doi: 10.1016/j.conctc.2019.100431. eCollection 2019 Dec. , Word Count: 284

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;

© 2019 The Authors.

KEYWORDS: Cancer survivors; Clinical trial; Prostate cancer; Qigong; Tai chi

PMID: 31650067 PMCID: PMC6804681 DOI: 10.1016/j.conctc.2019.100431