Project HERO: Health Empowerment & Recovery Outcomes
NCT03345563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113
Last updated 2025-01-27
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
Interventions
- BEHAVIORAL
-
Body Mind Training (BMT)
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.
- BEHAVIORAL
-
Body Training (BT):
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.
- BEHAVIORAL
-
Usual Care (UC)
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.
Sponsors & Collaborators
-
University of California, Los Angeles
collaborator OTHER -
University of New Mexico
collaborator OTHER -
Rutgers, The State University of New Jersey
lead OTHER
Principal Investigators
-
Anita Y Kinney, PhD, RN · Rutgers, The State University of New Jersey
-
Michael R. Irwin, MD · University of California, Los Angeles
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-31
- Primary Completion
- 2023-03-07
- Completion
- 2023-03-07
Countries
- United States
Study Locations
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