Status:
COMPLETED
Project HERO: Health Empowerment & Recovery Outcomes
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
University of California, Los Angeles
University of New Mexico
Conditions:
Prostate Cancer
Bladder Cancer
Eligibility:
MALE
55+ years
Phase:
NA
Brief Summary
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...
Detailed Description
This study will establish the efficacy of a 12-week Body Mind Training (BMT) for reductions in fatigue (the study's primary outcome). Secondary patient-reported outcomes include quality of life change...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2023
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT03345563
Start Date
July 31 2017
End Date
March 7 2023
Last Update
January 27 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rutgers University
New Brunswick, New Jersey, United States, 08901