A Body Mind Training (Tai Chi Qigong) in Reducing Fatigue in Prostate Cancer Survivors
This randomized phase II trial studies how well a body mind training called Tai Chi Qigong works in reducing fatigue in prostate cancer survivors. Tai Chi Qigong, a stretching movement program, may help reduce fatigue and improve well-being and quality of life in prostate cancer survivors.
Inclusion Criteria
- Previous diagnosis of local, regional, or metastatic prostate cancer
- If treated for cancer, prostate cancer therapy completed, 3+ months
- If on androgen deprivation therapy (ADT) / hormone manipulation, must be for 4 or more months
- Medical Health Outcome Study Short Form Vitality/Fatigue subscale (SF-36 Vitality scale) using a fatigue cut-off value of =< 13; or the Patient-Reported Outcomes Measurement Information System Fatigue scale (PROMIS Fatigue scale) using a cutoff value of >= 9
- Inactive (< 150 minutes of exercise/week within the past 3 months)
- Has transportation to attend on-site classes and assessments
Exclusion Criteria
- Patient Health Questionnaire PHQ-9 Score >= 12
- Indication of suicidality from PHQ-9, reports that he has several or more days of “thoughts that you would be better off dead, or of hurting yourself”
- Karnofsky performance status score of 50 or below
- Current regular practice within the past year (2-3 times a week over a period of two months that is not interrupted) of BMT or other complementary and alternative medicine that shares similar principles of BMT
- Inability to speak and read English proficiently
- Unable to understand informed consent
- Current health conditions that may interfere with the intervention: respiratory, cardiovascular, or neurological problems unless released by physician
- Medical conditions or activities that can cause severe fatigue: Severe hearing loss that would cause difficulty following an instructor in a group setting, chronic fatigue syndrome, current major depression, alcohol use disorder, shift work
- Prostate cancer that has metastasized to the liver, brain, or lungs
- Have had a diagnosis of other cancer, unless: * The diagnosis was of non-melanoma skin cancer; or * They completed treatment and have been cancer free for >= 5 year
- Currently receiving chemotherapy with VePesid, Cytoxan, intravenous chemotherapy or radionucleotides (Strontium-89, Samarium (Quadramet), Radium-223 (Xofigo), or other therapy (as confirmed by study team)
- Unwilling to be randomized to study arms and/or commit to 12 weeks of classes and assessments
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03345563.
PRIMARY OBJECTIVE:
I. Test the hypothesis that body mind training (BMT), as compared to body training (BT) or usual care (UC), will reduce fatigue (primary outcome) in inactive, elderly, prostate cancer survivors
SECONDARY OBJECTIVES:
I. Test the hypothesis that BMT, as compared to BT or UC, will reduce inflammation as indexed by a vertically integrated approach: systemic levels of pro- and anti-inflammatory cytokines, Toll-like receptor (TLR)-4 stimulated monocyte production of inflammatory cytokines, inflammatory signaling (e.g., nuclear factor, NF-kappaB) and promoter-based bioinformatics inflammatory transcriptional profiling.
II. Test the hypothesis that BMT, as compared to BT or UC, will alter expression of two major fatigue-associated functional clusters of genes: 1) inflammation, vasodilation and metabolite sensing and 2) energy and adrenergic activation.
III. Examine potential underlying theoretical mediating (changes in distress, perceived stress, sleep quality, functional and social well-being, physical activity, inflammation pathway markers, and gene expression) and moderating mechanisms (sociodemographic and clinical factors; body mass index [BMI], and participation of a companion in intervention classes) that are related to improvements in fatigue, which will further specify and elucidate intervention effects.
OUTLINE: Participants are randomized to 1 of 3 arms.
ARM I: Participants attend BMT (TCQ) sessions led by a certified BMT instructor consisting of series of exercises with low-intensity postures and deep breathing for 60 minutes twice per week (BIW) for 12 weeks. Participants also perform home-based BMT practice using a DVD and handouts for at least 30 minutes per day, 3 days per week for 12 weeks
ARM II: Participants attend BT sessions consisting of light intensity exercise classes for strength and flexibility for 60 minutes BIW for 12 weeks. Participants also perform home-based BT practice using a DVD and handouts for at least 30 minutes per day, 3 days per week for 12 weeks.
ARM III: Participants receive care as usual care.
After completion of study intervention, participants are followed up at 1 week, 3 months, and 12 months.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationRutgers Cancer Institute of New Jersey
Principal InvestigatorAnita Y. Kinney
- Primary IDUNM 1605
- Secondary IDsNCI-2018-00233, 131816, Pro2018002020
- ClinicalTrials.gov IDNCT03345563