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 |
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.
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.
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
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
Click here to add this to my saved trials