Clinical trial · Interventional
Project HERO: Health Empowerment & Recovery Outcomes
Biobehavioral Effects of Tai Chi Qigong (TCQ) for Male Cancer Survivors With Fatigue (HERO)
NCT03345563CI-TRIAL-00117037HEROcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Rectum Cancer | Rectal Carcinoma | ALIAS | 0.90 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
| Soft Tissue Cancer | — | UNRESOLVED | — |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Body Mind Training (BMT) | Behavioral | — | UNRESOLVED |
| Body Training (BT): | Behavioral | — | UNRESOLVED |
| Usual Care (UC) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Body Mind Training (BMT)
- description
- Body mind training
- interventionNames
- Behavioral: Body Mind Training (BMT)
- type
- ACTIVE_COMPARATOR
- label
- Body Training (BT)
- description
- Body training only
- interventionNames
- Behavioral: Body Training (BT):
- type
- OTHER
- label
- Usual care (UC):
- description
- Control
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 55 Years
Show eligibility criteria text
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 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
References
Publications (2)
- DERIVEDTundealao S, Irwin MR, Cole S, Blair CK, Lu SE, Saraiya B, Kim IY, Guest DD, Lin Y, An J, Arana-Chicas E, Chen C, Handorf E, Stroup A, Kang Y, Arap W, Kinney AY. Biological correlates of cancer-related fatigue in older male cancer survivors. Transl Psychiatry. 2026 Jul 17. doi: 10.1038/s41398-026-04274-1. Online ahead of print. PMID 42469198
- DERIVEDKinney AY, An J, Lin Y, Tundealao S, Saraiya B, Lu SE, Guest DD, Harding EM, Amorim F, Heidt E, Arana-Chicas E, Chen C, Boyce T, Kim IY, Arap W, Blair CK, Irwin MR. Project HERO: a randomized trial of Tai Chi qigong versus intensity-matched exercise and usual care for fatigue in older male cancer survivors. BMC Complement Med Ther. 2025 Jul 4;25(1):239. doi: 10.1186/s12906-025-04988-7. PMID 40616105