Prostate Cancer Clinical Trial

Soccer Intervention in Prostate Cancer Survivors

Summary

This study seeks to directly test the implementation feasibility of a soccer-based lifestyle change intervention vs a low-cost mobile-health (mHealth) enabled lifestyle intervention and determine their effects on bone health, body composition, mental health, functional and cardiometabolic status among prostate cancer survivors.

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Full Description

Prostate cancer (PCa) is the most common cancer in men in the U.S. and in other industrialized countries. The lifetime probability of PCa in males is one in nine, and it has a high economic burden, with costs expected to rise. Modern tailored treatment approaches, including androgen deprivation therapy (ADT), have resulted in longer life expectancy, but also longer treatment periods, which lead to significant adverse side effects. These often include decreased bone mineral density (BMD), increased risk of fractures, low functional capacity, loss of lean body mass (LBM), increased fat mass, insulin resistance, psychological distress and pain. Of particular concern is a sharp decline in bone health, with systemic bone loss caused by PCa-produced osteoclastogenic cytokines and drug interventions. Independent of disease stage, fractures in PCa patients are predictors of survival. In addition, concomitant physical inactivity and stress during and after treatment predispose PCa patients to elevated risk of deconditioning, BMD loss, cardiovascular and metabolic disease morbidity and mortality.

Exercise-based lifestyle interventions aimed at counteracting treatment-induced adverse effects have been shown to be safe and effective in improving bone, functional and cardiometabolic health for patients with PCa. However, men, in general, are harder to engage in physical activity (PA) and lifestyle interventions. As an alternative to traditional exercise programs, recreational team sports provide a unique environment that may lead to increased physical activity participation and motivation to engage in other lifestyle changes. More than any other sport, recreational soccer (RS) has been shown to be a successful health intervention in patients with, or at risk of chronic diseases, including PCa.

Leveraging the growing enthusiasm around soccer in Atlanta and the U.S. may lead to increased interest, participation, retention and engagement in lifestyle change programming among PCa survivors. Therefore, this study seeks to directly test the implementation feasibility of a soccer-based lifestyle change intervention to determine the effect on bone health, body composition, mental health, functional and cardiometabolic status among PCa survivors.

Participants will be offered an intensive intervention including RS programming and lifestyle education. The group will receive RS, consisting of conditioning drills and games, adapted to the population during 60-minute sessions twice per week. The researchers will evaluate health outcomes at baseline and after 3 months of the intervention.

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Eligibility Criteria

Inclusion Criteria:

men aged 18-79 years
PCa survivors that had at least 6 months of hormone therapy (i.e. ADT with testosterone lowering agents) within the past 10 years
not engaged in soccer practice or other exercise or lifestyle intervention program for the past 12 months
availability of smartphone to receive text messages
treating Oncologist clearance
ability to read in English or Spanish and provide informed consent

Exclusion Criteria:

BMI > 40 kg/m^2
resting BP ≥170/100 at screening or uncontrolled hypertension
any mobility issues or exercise program contraindications
a recent (i.e., within 12 months) myocardial infarction, diagnosis of congestive heart disease, other active cancer
bone or organ metastases
chemotherapy within past 6 months
therapies and diseases of bone unrelated to PCa e.g. systemic glucocorticoids, bisphosphonates, teriparatide, denosumab, osteomalacia; osteosarcoma; Paget's disease; systemic lupus erythematosus; inflammatory bowel diseases, rheumatoid arthritis; thyroid/parathyroid disorder or mental illness
not coronavirus disease 2019 (COVID-19) vaccinated

Study is for people with:

Prostate Cancer

Estimated Enrollment:

3

Study ID:

NCT04144127

Recruitment Status:

Completed

Sponsor:

Emory University

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There is 1 Location for this study

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Emory University Hospital
Atlanta Georgia, 30322, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

3

Study ID:

NCT04144127

Recruitment Status:

Completed

Sponsor:


Emory University

How clear is this clinincal trial information?

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