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

Cancer survivors are at an increased risk of bone loss due to previous cancer treatments and are at increased risk of obesity and other cardiometabolic diseases. Therefore it is important for cancer survivors to adhere to an active lifestyle and good nutrition. The study proposes a single site, pilot, randomized clinical trial to examine the efficacy of a lifestyle program that includes recreational soccer (RS) and nutrition education compared to mobile health lifestyle program to improve bone density and bone turnover.

It proposes that 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 prostate cancer (PCa) survivors. Therefore, this study seeks to directly test the implementation feasibility of a lifestyle change intervention in combination with RS and determine its effects in bone health, body composition, mental health, functional and cardiometabolic status among PCa survivors. A comparison group will receive usual care plus a low cost, mobile-health (mHealth) enabled lifestyle intervention, without supervised physical activity (PA) programming.

The aim is to recruit 40 men (50% African American or Latino) that have been in survivor status for at least 6 months from several Winship Cancer Institute clinical sites. The trial will exclude those with metastatic disease, already too active, and with any contraindications to exercise. The participants will be randomized after eligibility screening and will be scheduled for baseline assessments. The intervention group will be offered twice/week 60-minute soccer conditioning sessions using an evidence-based Football Fitness curriculum, delivered by trained soccer coaches. They will also receive lifestyle education including nutrition and other American Heart Association (AHA) Life's Simple 7 core messages after soccer sessions for 15 minutes. The comparison group will receive weekly educational and motivational text messages, aimed at improving physical activity (PA) and lifestyles. Both intervention and comparison groups will receive a wearable Garmin device to objectively monitor PA volume (steps) and intensity (minutes of moderate and vigorous) PA, as well as sedentary and sleep time. The study will assess pre and post differences in bone mineral density (primary outcome), body composition (DXA), bone turnover biomarkers, anthropometrics, diet, physical fitness, blood pressure and patient-reported outcomes including PA and diet self-efficacy, quality of life and depression. The trial will also compare the compliance with the federal recommendations of 150 weekly minutes of moderate-to-vigorous PA between the recreational soccer-based intervention and the comparison group, as a marker of program adherence.

All study assessments will be conducted at the Emory Clinical Research Center on the Clifton Campus and the intervention group will have their soccer sessions on a soccer field in the Atlanta area that is convenient for the participants. All participants will be given gift cards for each assessment visit.

The investigators anticipate the RS program will be more efficacious in preventing bone loss and increasing weight loss in PCa survivors. This study will engage men in a lifestyle program that has the potential to sustain healthy behaviors beyond the term of the study.

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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; 5) Treating Oncologist clearance 6) ability to read in English or Spanish and provide informed consent;

Exclusion Criteria:

BMI > 40 kg/m2
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.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

20

Study ID:

NCT04144127

Recruitment Status:

Recruiting

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 More Info
Roberto Felipe Lobelo, MD
Contact
770-488-5737
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

20

Study ID:

NCT04144127

Recruitment Status:

Recruiting

Sponsor:


Emory University

How clear is this clinincal trial information?

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