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NCT number NCT03345563
Study type Interventional
Source University of New Mexico
Contact Mark L Andrews, MA
Phone 505-272-4359
Email MAndrews@salud.unm.edu
Status Recruiting
Phase N/A
Start date September 1, 2017
Completion date August 31, 2021

Clinical Trial Summary

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.


Clinical Trial 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, 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.


Study Design


Related Conditions & MeSH terms


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