Project HERO: Health Empowerment & Recovery Outcomes
Completed · Not applicable
Conditions studied: Prostate Cancer, Bladder Cancer, Kidney Cancer, Colon Cancer, Rectum Cancer, Thyroid Cancer, Lung Cancer, Small Intestine Cancer, Soft Tissue Cancer
In brief
Project HERO is a 12-week study of the efficacy of Body Mind Training (BMT, i.e. Tai Chi and Qigong in this project) for reducing fatigue in male cancer survivors. This 3-arm randomized clinical trial will examine inflammatory biology and selected gene-expression pathways that are hypothesized to contribute to the intervention's effect.
Key facts
- Study ID
- NCT03345563
- Run by
- Rutgers, The State University of New Jersey
- People needed
- 113
- Starts
- 2017-07-31
- Expected to finish
- 2023-03-07
- Last updated by the study team
- 2026-07-07
Who can join
Age: 55 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 55 years
- Previous diagnosis of local, regional, or metastatic cancer. If treated for cancer, prostate cancer therapy completed, 3+ months. If on ADT/ hormone manipulation, must be for 4 or more months
- Previous diagnosis of small intestine, thyroid, oral, non-muscle invasive bladder, kidney/renal, lung, colon, rectum, soft tissue, or other cancer
- Meet study criteria for fatigue: Medical Health Outcome Study Short Form Vitality/Fatigue subscale (SF-36 Vitality scale-4 items; 5 Likert scale) using a fatigue cut-off value of ≤13; or the Patient-Reported Outcomes Measurement Information System Fatigue scale (PROMIS Fatigue scale) using a cut-off value of ≥9
- Live within 75 miles of New Brunswick or Newark
- Inactive (<150 minutes of vigorous exercise/week within the past 3 months)
- Has transportation to attend on-site classes and assessments
You may not qualify if…
- 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 a 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
- Currently receiving chemotherapy with VePesid, Cytoxan, Enzalutamide (XTANDI®), 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
- Have had a diagnosis of another cancer, unless:
- Non-melanoma skin cancer or
- Completed treatment AND cancer-free for 5 or more years.
- We will not include any of the following special populations:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Where it is running
- Rutgers University — New Brunswick, New Jersey, United States
Full record on ClinicalTrials.gov
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