Body Mind Training for Cancer Fatigue in Male Survivors

(HERO Trial)

Recruiting at 1 trial location

Overseen By Olivia R Foran

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must be taking: Hormone manipulation

Must not be taking: Chemotherapy, Radionucleotides

Disqualifiers: Suicidality, Major depression, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

113 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Anita Y Kinney, PhD, RN

Principal Investigator

Rutgers, The State University of New Jersey

Michael R. Irwin, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

Men over 55, inactive with fatigue after cancer treatment, living near New Brunswick or Newark. They must have had certain cancers and finished therapy at least 3 months ago or been on hormone therapy for prostate cancer for over 4 months. Excluded if severely depressed, suicidal, very ill, practicing similar therapies recently, non-English speakers, or with specific medical conditions.

Inclusion Criteria

I can travel to attend classes and assessments.

I have been diagnosed with a specific type of cancer before.

Lives within 75 miles of New Brunswick or Newark

Exclusion Criteria

I am willing to be assigned to a study group and can commit to 12 weeks of classes and assessments.

Your PHQ-9 score is higher than 12.

Inability to speak and read English proficiently

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants undergo a 12-week Body Mind Training (BMT) intervention to reduce fatigue

12 weeks

Weekly sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits at week 13, 3 months, and 12 months

Treatment Details

Interventions

• Body Mind Training (BMT)
• Body Training (BT)
• Usual Care (UC)

Trial Overview Project HERO tests Body Mind Training (BMT) against Body Training (BT) and Usual Care (UC) to see if BMT reduces fatigue in male cancer survivors. It's a randomized trial that also looks at inflammation and gene changes possibly affected by the training.

Participant Groups

Group I: Usual care (UC): Experimental Treatment 1 Intervention

Control

Group II: Body Mind Training (BMT) Experimental Treatment 1 Intervention

Body mind training

Group III: Body Training (BT) Active Control 1 Intervention

Body training only

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+