Soccer Intervention in Prostate Cancer Survivors

NCT ID: NCT04144127

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-25
• Study Completion Date: 2022-07-15

Brief Summary

This study seeks to directly test the implementation feasibility of a soccer-based and lifestyle education intervention to determine the effects on bone health, body composition, mental health, functional and cardiometabolic status among prostate cancer survivors.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Soccer Group

Participants in the soccer group will participate in soccer drills and other fitness routines (two 1-hour sessions per week). They will meet with the soccer coach after the soccer sessions to discuss the lifestyle education topics (Life's Simple 7 education topics). During the soccer sessions participants will be fitted with a wearable soccer-specific device to measure how much they move and their heart rate. All participants will receive a Garmin Vivofit wearable device to help monitor their PA goals and achievements.

Group Type: EXPERIMENTAL

Soccer

Intervention Type: BEHAVIORAL

• Soccer drills and other fitness routines (two 1-hour sessions per week)
• In person education in Life's Simple 7 to help improve life through Lifestyle changes: smoking status, physical activity, weight, diet, blood glucose, cholesterol, and blood pressure.

Interventions

Soccer

• Soccer drills and other fitness routines (two 1-hour sessions per week)
• In person education in Life's Simple 7 to help improve life through Lifestyle changes: smoking status, physical activity, weight, diet, blood glucose, cholesterol, and blood pressure.

Intervention Type: BEHAVIORAL

Other Intervention Names

Recreational Soccer (RS)

Eligibility Criteria

Inclusion Criteria

1. men aged 18-79 years

2. PCa survivors that had at least 6 months of hormone therapy (i.e. ADT with testosterone lowering agents) within the past 10 years

3. not engaged in soccer practice or other exercise or lifestyle intervention program for the past 12 months

4. availability of smartphone to receive text messages

5. treating Oncologist clearance

6. ability to read in English or Spanish and provide informed consent

Exclusion Criteria

1. BMI > 40 kg/m^2

2. resting BP ≥170/100 at screening or uncontrolled hypertension

3. any mobility issues or exercise program contraindications

4. a recent (i.e., within 12 months) myocardial infarction, diagnosis of congestive heart disease, other active cancer

5. bone or organ metastases

6. chemotherapy within past 6 months

7. 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

8. not coronavirus disease 2019 (COVID-19) vaccinated

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Felipe Lobelo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Felipe Lobelo, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00110890

Identifier Type: -

Identifier Source: org_study_id