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Brief Title: Project HERO: Health Empowerment & Recovery Outcomes
Official Title: Biobehavioral Effects of Body Mind Training (BMT) for Male Cancer Cancer Survivors With Fatigue (HERO)
Study ID: NCT03345563
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.
Minimum Age: 55 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Rutgers University, New Brunswick, New Jersey, United States
Name: Anita Y Kinney, PhD, RN
Affiliation: Rutgers, The State University of New Jersey
Role: PRINCIPAL_INVESTIGATOR
Name: Michael R. Irwin, MD
Affiliation: University of California, Los Angeles
Role: PRINCIPAL_INVESTIGATOR