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Body Mind Training for Cancer Fatigue in Male Survivors (HERO Trial)

N/A
Waitlist Available
Led By Anita Y Kinney, PhD, RN
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previous diagnosis of specific types of cancer including small intestine, thyroid, oral, non-muscle invasive bladder, kidney/renal, lung, colon, rectum, soft tissue, or other cancer
Age ≥ 55 years
Must not have
Prostate cancer that has metastasized to specific organs
Karnofsky performance status score of 50 or below
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how well BMT (Body Mind Training) works in reducing fatigue in male cancer survivors.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this study involves exercise and mind-body training rather than drugs or invasive procedures, side effects may include muscle soreness or strain from physical activity. Psychological discomfort could occur but is less likely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a specific type of cancer before.
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I am 55 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My prostate cancer has spread to other organs.
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I need considerable assistance and medical care.
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I am currently on a specific chemotherapy or other treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Functional Assessment of Chronic Illness (FACIT)-Fatigue Scale
Secondary study objectives
Brief Symptom Inventory-18 (BSI-18)
Consensus Sleep Diary
Gene Expression
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Usual care (UC):Experimental Treatment1 Intervention
Control
Group II: Body Mind Training (BMT)Experimental Treatment1 Intervention
Body mind training
Group III: Body Training (BT)Active Control1 Intervention
Body training only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Usual Care (UC)
2016
N/A
~3810

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
452 Previous Clinical Trials
69,399 Total Patients Enrolled
University of California, Los AngelesOTHER
1,567 Previous Clinical Trials
10,266,887 Total Patients Enrolled
University of New MexicoOTHER
387 Previous Clinical Trials
3,526,292 Total Patients Enrolled
Anita Y Kinney, PhD, RNPrincipal InvestigatorRutgers, The State University of New Jersey
5 Previous Clinical Trials
1,247 Total Patients Enrolled
Michael R. Irwin, MDPrincipal InvestigatorUniversity of California, Los Angeles
2 Previous Clinical Trials
263 Total Patients Enrolled

Media Library

Body Mind Training (BMT) Clinical Trial Eligibility Overview. Trial Name: NCT03345563 — N/A
Lung Cancer Research Study Groups: Usual care (UC):, Body Training (BT), Body Mind Training (BMT)
Lung Cancer Clinical Trial 2023: Body Mind Training (BMT) Highlights & Side Effects. Trial Name: NCT03345563 — N/A
Body Mind Training (BMT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03345563 — N/A
~18 spots leftby Dec 2025