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

Anita Y. Kinney; Cindy K. Blair; Dolores D. Guest; Julianne K. Ani; Elizabeth M. Harding; Fabiano Amorim; Tawny Boyce; Joseph Rodman; C. Graham Ford; Matthew Schwartz; Larissa Rosenberg; Olivia Foran; Jerry Gardner; Yong Lin; Wadih Arap; Michael R. Irwin

Contemporary Clinical Trials Communications (Dec 2019)

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

Anita Y. Kinney,
Cindy K. Blair,
Dolores D. Guest,
Julianne K. Ani,
Elizabeth M. Harding,
Fabiano Amorim,
Tawny Boyce,
Joseph Rodman,
C. Graham Ford,
Matthew Schwartz,
Larissa Rosenberg,
Olivia Foran,
Jerry Gardner,
Yong Lin,
Wadih Arap,
Michael R. Irwin

Affiliations

Anita Y. Kinney: Department of Biostatistics and Epidemiology, School of Public Health, Rutgers University, Piscataway, NJ, USA; Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA; Corresponding author. Rutgers Cancer Institute of New Jersey, 195 Little Albany Street New Brunswick, New Jersey, 08901, USA.
Cindy K. Blair: Department of Internal Medicine, University of New Mexico, Albuquerque, NM, USA; University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA
Dolores D. Guest: University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA
Julianne K. Ani: Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA
Elizabeth M. Harding: University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA
Fabiano Amorim: Department of Health, Exercise and Sports Sciences, University of New Mexico, Albuquerque, NM, USA
Tawny Boyce: University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA
Joseph Rodman: University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA
C. Graham Ford: University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA; Department of Psychology, University of New Mexico, Albuquerque, NM, USA
Matthew Schwartz: Department of Internal Medicine, University of New Mexico, Albuquerque, NM, USA; University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA
Larissa Rosenberg: Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA
Olivia Foran: Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA
Jerry Gardner: Department of Theatre, University of Utah, Salt Lake City, UT, USA
Yong Lin: Department of Biostatistics and Epidemiology, School of Public Health, Rutgers University, Piscataway, NJ, USA; Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA
Wadih Arap: Division of Hematology/Oncology, Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA; Rutgers Cancer Institute of New Jersey, Newark, NJ, USA
Michael R. Irwin: Cousins Center for Psychoneuroimmunology, Semel Institute for Neurosciences, University of California Los Angeles, California, USA; Department of Psychiatry, David Geffen School of Medicine, University of California, Los Angeles, CA, USA

Journal volume & issue: Vol. 16

Abstract

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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. Keywords: Prostate cancer, Clinical trial, Tai chi, Qigong, Cancer survivors

Published in Contemporary Clinical Trials Communications

ISSN: 2451-8654 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Medicine (General)
Website: https://www.journals.elsevier.com/contemporary-clinical-trials-communications/

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