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Body Mind Training for Cancer Fatigue in Male Survivors (HERO Trial)
N/A
Waitlist Available
Led By Michael R. Irwin, MD
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
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
HERO Trial 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.Check my eligibility
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.See study design
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.
HERO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of cancer before.
Select...
I am 55 years old or older.
HERO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional Assessment of Chronic Illness (FACIT)-Fatigue Scale
Secondary outcome measures
Berlin Sleep Questionnaire
Brief Symptom Inventory-18 (BSI-18)
Consensus Sleep Diary
+3 moreHERO 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
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can travel to attend classes and assessments.I am willing to be assigned to a study group and can commit to 12 weeks of classes and assessments.I have been diagnosed with a specific type of cancer before.Your PHQ-9 score is higher than 12.I have used alternative medicine or BMT in the last year.You have shown signs of feeling suicidal on the PHQ-9 questionnaire.You have fatigue as determined by specific measurements and thresholds.My prostate cancer has spread to other organs.I have been cancer-free for 5+ years, except for non-melanoma skin cancer.My doctor has cleared me to participate despite my respiratory, cardiovascular, or neurological conditions.You have not been doing enough intense exercise in the past three months.I am 55 years old or older.I need considerable assistance and medical care.I have conditions or do activities that make me very tired.I finished prostate cancer treatment over 3 months ago or have been on hormone therapy for 4+ months.I am currently on a specific chemotherapy or other treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care (UC):
- Group 2: Body Training (BT)
- Group 3: Body Mind Training (BMT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment phase for this clinical trial ongoing?
"Affirmative. According to clinicaltrials.gov, this trial is presently seeking participants; it first appeared on July 19th 2019 and was last revised on September 27th 2022. Altogether, 210 patients need to be enrolled from two separate sites."
Answered by AI
How many individuals have committed to participating in this research project?
"Affirmative, the clinical trial database reveals that recruitment is still in progress. This study was originally posted on July 19th 2019 and last edited September 27th 2022. The two sites are looking to enroll 210 participants combined."
Answered by AI
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