Project HERO: Health Empowerment & Recovery Outcomes

NCT03345563 | Completed DMC

• 2 other identifiers: 131816Pro2018002020
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer; Bladder Cancer; Kidney Cancer; Colon Cancer; Rectum Cancer; Thyroid Cancer; Lung Cancer; Small Intestine Cancer; Soft Tissue Cancer

Keywords

Prostate Cancer; Fatigue; Elderly; Supportive Care; Light Exercise; Quality of Life; Bladder Cancer; Kidney Cancer; Colon Cancer; Rectum Cancer; Throid Cancer; Lung Cancer; Small Intestine Cancer; Soft Tissue Cancer

Outcome Measures

Primary Outcomes (1)

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

  Change in fatigue levels from baseline to 3-months post intervention: measured with 13-item scale assessing the level of fatigue during usual activities over the 7 days prior to the measurement timepoint, with higher scores indicating less fatigue. Administered at several time points to measure the effect the intervention.

  Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months

Secondary Outcomes (6)

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months

• Inflammation Biology Measures: Changes in circulating levels pro- and anti-inflammatory biomarkers will be assessed by measuring NF-κB and AP-1.

  Baseline (2 weeks pre-intervention), and post-intervention at week 13, 3 months, and 12 months

• Gene Expression

  Baseline (2 weeks pre-intervention), and post-intervention at week 13, 3 months, and 12 months

• Brief Symptom Inventory-18 (BSI-18)

  Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months

• SF-36v2 Health-Related Quality of Life Survey (Mental and Physical)

  Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months

Study Arms (3)

Body Mind Training (BMT)

EXPERIMENTAL

Body mind training

Behavioral: Body Mind Training (BMT)

Body Training (BT)

ACTIVE COMPARATOR

Body training only

Behavioral: Body Training (BT):

Usual care (UC):

OTHER

Control

Behavioral: Usual Care (UC)

Interventions

Body Mind Training (BMT) BEHAVIORAL

Participants will practice BMT under the instruction of a BMT instructor. There will be 24 sessions. Each session will last 60 minutes and will occur twice a week for 12 weeks. Each session will include both light physical exercise and mind training. Sessions will be supplemented with home-based practice using an instructional DVD and handouts. Participants will be instructed to practice at least 30 minutes a day (at least 3 days per week) throughout the intervention and post-intervention period.

Body Mind Training (BMT)

Body Training (BT): BEHAVIORAL

Participants will practice BT under the instruction of a BT instructor. There will be 24 sessions. Each session will last 60 minutes and will occur twice a week for 12 weeks. Sessions will be supplemented with home-based practice using an instructional DVD and handouts. Participants will be instructed to practice at least 30 minutes a day (at least 3 days per week) throughout the intervention and post-intervention period.

Body Training (BT)

Usual Care (UC) BEHAVIORAL

Participants in the usual care arm will receive care as normal and will not attend classes but will complete the same assessments as participants in the BMT and BT classes.

Usual care (UC):

Eligibility Criteria

• Age: 55 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• University of California, Los Angeles: collaborator
• University of New Mexico: collaborator

Study Sites (1)

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (1)

• Kinney 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 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Bladder Neoplasms; Kidney Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Thyroid Neoplasms; Lung Neoplasms; Sarcoma; Fatigue

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases; Kidney Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anita Y Kinney, PhD, RN

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

• Michael R. Irwin, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will be instructed not to discuss their arm assignment with study personnel during their assessments. We avoided the use of the terms Tai Chi and Qigong for participant recruitment, patient-faced materials, and intervention implementation. Questionnaires will be self-administered, administered in person or by telephone based on participant need and preference. Some investigators, the data manager, biostatisticians, biometric testing and lab technicians will be blinded to intervention allocation. The technicians who analyze biospecimens will be blinded to all other data.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator; Associate Director for Cancer Health Equity

Model Details: After obtaining informed consent and baseline assessments, cancer survivors aged 55 years and older with some level of fatigue will be randomized to the BMT arm or intensity-matched Body Training (BT), or Usual Care (UC) arms. Patient-reported assessments (surveys) will occur at baseline (within 2-weeks pre- intervention), mid-intervention (6 weeks), 1-week post-intervention (13 weeks), and at 3 months and 12 months post-intervention. Phlebotomy is done at baseline, 1 week post intervention (13 weeks), and 3 months and 12 months post intervention. Dietary assessments are done at baseline, and week 13 (1 week post intervention), 3 months and 1 year post-intervention. Physical activity is assessed weekly throughout the intervention. Sleep diaries are collected at all time points.

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 17, 2017
• Study Start: July 31, 2017
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)