CompletedNot Applicable

Project HERO: Health Empowerment & Recovery Outcomes

United States113 participantsStarted 2017-07-31

Plain-language 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 will examine inflammatory biology and selected gene-expression pathways that are hypothesized to contribute to the intervention's effect.

Who can participate

Age range

55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 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 m…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale

Timeframe: Baseline, 6 weeks, 1 week post-intervention, 3 months, 12 months post-intervention

Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale

Timeframe: Baseline, 6 weeks, 1 week post-intervention, 3 months, 12 months post-intervention

Trial details

NCT IDNCT03345563

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-07

Results submitted2026-04-28

View on ClinicalTrials.gov More Prostate Cancer trials

Plain-language summary

Who can participate

Age range

55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale

Timeframe: Baseline, 6 weeks, 1 week post-intervention, 3 months, 12 months post-intervention

Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale

Timeframe: Baseline, 6 weeks, 1 week post-intervention, 3 months, 12 months post-intervention