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Brief Title: Project HERO: Health Empowerment & Recovery Outcomes

Biobehavioral Effects of Body Mind Training (BMT) for Male Cancer Cancer Survivors With Fatigue (HERO)

INTRODUCTION

  • Org Study ID: 131816
  • Secondary ID: N/A
  • NCT ID: NCT03345563
  • Sponsor: Rutgers, The State University of New Jersey

BRIEF 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.

DETAILED 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.

  • Overall Status
    Active, not recruiting
  • Start Date
    July 19, 2019
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Prostate Cancer
  • Bladder Cancer
  • Kidney Cancer
  • Colon Cancer
  • Rectum Cancer
  • Thyroid Cancer
  • Lung Cancer
  • Small Intestine Cancer
  • Soft Tissue Cancer

ELIGIBILITY

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 exercise/week 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

Gender: Male

Minimum Age: 55 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Anita Y Kinney, PhD, RN, Michael R. Irwin, MD

Role: Principal Investigator, Principal Investigator

Affiliation: Rutgers, The State University of New Jersey, University of California, Los Angeles

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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