Prostate Cancer Clinical Trial

Project HERO: Health Empowerment & Recovery Outcomes

Summary

Project HERO is a 12-week study of the efficacy of Body Mind Training (BMT) 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.

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Full Description

This study will establish the efficacy of a 12-week Body Mind Training (BMT) for reductions in fatigue (the study's primary outcome). Secondary patient-reported outcomes include quality of life changes (e.g. changes in sleep and perceived psychological distress), changes in the biomarkers of inflammation; including genome wide transcriptional factors, and expression of fatigue-related genes.

There are over 9 million cancer survivors that are 55 years of age or older. Cancer survivors in this age group have unique challenges coping with late and long-term effects of having had a cancer diagnosis and treatment, coupled with age-related declines and comorbidities. This may influence their ability to engage in lifestyle interventions because of slower post-treatment recovery, increased functional limitations, and other quality of life (QOL) impairments. Fatigue is common, under-recognized, undertreated and correlated with impairments in psychological distress, social and functional well-being and health-related QOL in cancer survivors. For male cancer survivors suffering from fatigue, body-mind training (BMT) may be more appealing because it is not overly physically exertive and is safe for people 55 years of age or older.

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Eligibility Criteria

Criteria: Inclusion Criteria:

Age ≥ 55 years
Previous diagnosis of local, regional, or metastatic cancer. If treated for cancer, prostate cancer therapy completed, 3+ months If on ADT/ hormone manipulation, must be for 4 or more month
Previous diagnosis of small intestine, thyroid, oral, non-muscle invasive bladder, kidney/renal, lung, colon, rectum, soft tissue, or other cancer
Meet study criteria for fatigue (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAEv4.0)) using a fatigue cut-off value of ≥1 or a general fatigue grading scale (i.e., fatigue currently and in the past week from a scale of 0-100) with a cut-off value of >20
Live within 75 miles of New Brunswick or Newark
Inactive (<150 minutes of vigorous exerciseweek within the past 3 months)
Has transportation to attend on-site classes and assessments

Exclusion Criteria:

Patient Health Questionnaire PHQ-9 Score >12
Indication of suicidality from PHQ-9, reports that he has several or more days of "thoughts that you would be better off dead, or of hurting yourself"
Karnofsky performance status score of 50 or below
Current regular practice within the past year (2-3 times a week over a period of two months that is not interrupted) of BMT or other complementary and alternative medicine that shares similar principles of BMT.
Inability to speak and read English proficiently
Unable to understand informed consent
Current health conditions that may interfere with the intervention: respiratory, cardiovascular, or neurological problems unless released by physician
Medical conditions or activities that can cause severe fatigue: Severe hearing loss that would cause difficulty following an instructor in a group setting, chronic fatigue syndrome, current major depression, alcohol use disorder, shift work
Prostate cancer that has metastasized to the liver, brain, or lungs
Currently receiving chemotherapy with VePesid, Cytoxan, Enzalutamide (XTANDI®), intravenous chemotherapy or radionucleotides (Strontium-89, Samarium (Quadramet®), Radium-223 (Xofigo®)), or other therapy (as confirmed by study team)
Unwilling to be randomized to study arms and/or commit to 12 weeks of classes and assessments

Have had a diagnosis of another cancer, unless:

Non-melanoma skin cancer, or
Completed treatment AND cancer-free for 5 or more years.

We will not include any of the following special populations:

Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners

Study is for people with:

Prostate Cancer

Estimated Enrollment:

210

Study ID:

NCT03345563

Recruitment Status:

Recruiting

Sponsor:

Rutgers, The State University of New Jersey

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There are 2 Locations for this study

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RWJ Barnabas Health - Jersey City Medical Center
Jersey City New Jersey, 07302, United States
Rutgers University
New Brunswick New Jersey, 08901, United States More Info
Anita Y Kinney, PhD, RN
Contact
[email protected]

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

210

Study ID:

NCT03345563

Recruitment Status:

Recruiting

Sponsor:


Rutgers, The State University of New Jersey

How clear is this clinincal trial information?

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