Project HERO: Health Empowerment & Recovery Outcomes



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:55 - Any
Updated:11/19/2017
Start Date:September 1, 2017
End Date:August 31, 2021
Contact:Mark L Andrews, MA
Email:MAndrews@salud.unm.edu
Phone:505-272-4359

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

Project HERO is a 12-week study of the efficacy of Body Mind Training (BMT) for reducing
fatigue in prostate 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.

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, including men with prostate cancer. For prostate 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.

Criteria: Inclusion Criteria:

- Age ≥ 55 years

- Previous diagnosis of local, regional, or metastatic prostate cancer If treated for
cancer, prostate cancer therapy completed, 3+ months If on ADT/ hormone manipulation,
must be for 4 or more months

- 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 Albuquerque

- 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
We found this trial at
1
site
Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Albuquerque, NM
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