Prostate cancer is diagnosed in approximately 16% of U.S. men, at a median age of 67 years, and the survival rates are high. Survivors are likely to experience poorer quality of life (QOL) due to the long-term side effects of treatment that are coupled with age-related declines in physical, mental and social functioning. Fatigue is 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 of sleep quality, and impairments in health-related QOL. Inflammatory processes and changes in the hypothalamic- pituitary-adrenal (HPA) axis and autonomic nervous system may also play a role in cancer-related fatigue. Thus, effective treatments for fatigue in elderly prostate cancer survivors are urgently needed. Prior research has shown that Tai Chi Qigong (TCQ), a mind-body exercise intervention, can improve physical and emotional health. However, no definitive clinical trial has demonstrated its efficacy compared to activity-matched and health education control groups as a treatment for fatigue in senior, inactive prostate cancer survivors. Therefore, we propose to conduct a randomized controlled trial of TCQ for reducing fatigue in prostate cancer survivors. This mind-body exercise intervention focuses on deep breathing techniques, slow deliberate movements, holding specific postures, and meditation to induce relaxation. In this trial, 210 elderly prostate cancer survivors (? 60 years) with fatigue will complete either a TCQ, streching movement or health education class. Classes will be held for 60 minutes, twice a week, over a 12-week period. Guided by biopsychosocial and psycho-neuroimmunology models we will test the hypotheses that a TCQ intervention, as compared to stretching movement or health education, will: 1) reduce fatigue (primary outcome) in inactive, elderly, prostate cancer survivors; 2) reduce inflammation as indexed by a vertically integrated approach: systemic levels of pro- and anti-inflammatory cytokines (ELISA), Toll-like receptor (TLR)-4 stimulated monocyte production of inflammatory cytokines, activation of inflammation-related transcription factors (e.g., NF-?B) and gene expression profiling with promoter based bioinformatics; and 3) regulate the expression of genes from two major functional clusters previously found to be associated with fatigue in prostate cancer patients: a) inflammation, vasodilation and metabolite sensing and b) energy and adrenergic activation. Measurements (baseline, 6-week midpoint intervention, and 1-week, 3-months, and 12-months post-intervention) will assess fatigue as well as potential mediating factors including psychological distress, mental and physical QOL, sleep quality, perceived stress, physical activity, and social well being. We hypothesize that relative to the streching movement and health education control conditions, TCQ will result in improvements in fatigue, in inflammation biomarkers and gene expression markers associated with fatigue. We will also evaluate underlying physical, psychosocial and biological pathways by which TCQ exerts its effects on fatigue.

Public Health Relevance

Effective interventions for reducing fatigue experienced by elderly cancer survivors are needed. This study evaluates the efficacy of a mind-body intervention, Tai Chi Qigong, to improve fatigue experienced by elderly prostate cancer survivors. Examination of the effects of Tai Chi Qigong on physical, psychosocial and biological measures, including inflammatory biology pathways and fatigue-related gene expression, will increase our understanding of underlying biobehavioral mechanisms and inform evidence-based recommendations for survivorship care.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
7R01CA203930-03
Application #
9605018
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
Green, Paige A
Project Start
2016-12-09
Project End
2021-11-30
Budget Start
2018-12-01
Budget End
2019-11-30
Support Year
3
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Rbhs -Cancer Institute of New Jersey
Department
Type
Overall Medical
DUNS #
078728091
City
New Brunswick
State
NJ
Country
United States
Zip Code
08901