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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 belowSelect...
I have been diagnosed with a specific type of cancer before.
Select...
I am 55 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My prostate cancer has spread to other organs.
Select...
I need considerable assistance and medical care.
Select...
I am currently on a specific chemotherapy or other treatment.
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
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 moreAwards & 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
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.