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

Anita Y Kinney^{1

2}, Cindy K Blair^{3

4}, Dolores D Guest⁴, Julianne K Ani², Elizabeth M Harding⁴, Fabiano Amorim⁵, Tawny Boyce⁴, Joseph Rodman⁴, C Graham Ford^{4

6}, Matthew Schwartz^{3

4}, Larissa Rosenberg², Olivia Foran², Jerry Gardner⁷, Yong Lin^{1

2}, Wadih Arap^{8

9}, Michael R Irwin^{10

11}

Affiliations

¹ Department of Biostatistics and Epidemiology, School of Public Health, Rutgers University, Piscataway, NJ, USA.
² Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
³ Department of Internal Medicine, University of New Mexico, Albuquerque, NM, USA.
⁴ University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA.
⁵ Department of Health, Exercise and Sports Sciences, University of New Mexico, Albuquerque, NM, USA.
⁶ Department of Psychology, University of New Mexico, Albuquerque, NM, USA.
⁷ Department of Theatre, University of Utah, Salt Lake City, UT, USA.
⁸ Division of Hematology/Oncology, Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.
⁹ Rutgers Cancer Institute of New Jersey, Newark, NJ, USA.
¹⁰ Cousins Center for Psychoneuroimmunology, Semel Institute for Neurosciences, University of California Los Angeles, California, USA.
¹¹ Department of Psychiatry, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.

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

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

Anita Y Kinney et al. Contemp Clin Trials Commun. 2019.

. 2019 Aug 21:16:100431.

doi: 10.1016/j.conctc.2019.100431. eCollection 2019 Dec.

Authors

Affiliations

¹ Department of Biostatistics and Epidemiology, School of Public Health, Rutgers University, Piscataway, NJ, USA.
² Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
³ Department of Internal Medicine, University of New Mexico, Albuquerque, NM, USA.
⁴ University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA.
⁵ Department of Health, Exercise and Sports Sciences, University of New Mexico, Albuquerque, NM, USA.
⁶ Department of Psychology, University of New Mexico, Albuquerque, NM, USA.
⁷ Department of Theatre, University of Utah, Salt Lake City, UT, USA.
⁸ Division of Hematology/Oncology, Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.
⁹ Rutgers Cancer Institute of New Jersey, Newark, NJ, USA.
¹⁰ Cousins Center for Psychoneuroimmunology, Semel Institute for Neurosciences, University of California Los Angeles, California, USA.
¹¹ Department of Psychiatry, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.

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

Abstract

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

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Figures

**Fig. 2**
Proposed Study Design and CONSORT Diagram showing the flow of participants and anticipated numbers at each stage.

See this image and copyright information in PMC

References

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

Affiliations

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

Authors

Affiliations

Abstract

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References

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical