Project HERO: Health Empowerment & Recovery Outcomes

NCT03345563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2025-01-27

No results posted yet for this study

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

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03345563 on ClinicalTrials.gov