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Prostate Cancer Soccer

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ClinicalTrials.gov Identifier: NCT04144127
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Roberto Felipe Lobelo, Emory University

Tracking Information
First Submitted Date  ICMJE October 28, 2019
First Posted Date  ICMJE October 30, 2019
Last Update Posted Date October 31, 2019
Actual Study Start Date  ICMJE October 25, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
Change in Lumbar Spine Bone Mineral Density (BMD) [ Time Frame: 6 months post-intervention ]
Bone mineral density will be measured by dual x-ray absorptiometry (DXA) scan at the lumbar spine (L2-L4). Decreased BMD at 6 months post-intervention is associated with worse outcome.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04144127 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
  • Change in total hip BMD [ Time Frame: 6 months post-intervention ]
    Bone mineral density will be measured by dual x-ray absorptiometry (DXA) scan at the hip. Decreased BMD at 6 months post-intervention is associated with worse outcome.
  • Change in Osteocalcin [ Time Frame: 6 months post-intervention ]
    Osteocalcin is marker of bone formation
  • Change in C-terminal telopeptide of collagen (CTx) [ Time Frame: 6 months post-intervention ]
    C-terminal telopeptide of collagen (CTx) is a bone resorption marker
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prostate Cancer Soccer
Official Title  ICMJE A Soccer-based Lifestyle Intervention vs mHealth-based Physical Activity Intervention to Improve Bone Health and Metabolic Health in Prostate Cancer Survivors
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Behavioral: 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.
    Other Name: Recreational Soccer (RS)
  • Behavioral: mHealth
    It is an online platform is accessible on a smartphone application (IOS or Android) or desktop, to help patients monitor their physical activity (PA) data weekly and receive messages for behavior change support and reminders for data synchronization. The study team will send two short text messages twice weekly: one message will be focused on a weekly goal for minutes of moderate-to-vigorous PA; and the second will be based on one of the AHA's Life's Simple 7, including lifestyle messages so the participants can improve through lifestyle changes, helping to achieve ideal cardiovascular health.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Soccer
  • Active Comparator: mHealth Education Group

    The mHealth education group receive brochures on the American Heart Association (AHA) Life's Simple 7 and encouraged to visit the AHA's My Life Check website for customized lifestyle recommendations. All participants will receive a Garmin Vivofit wearable device to help monitor their PA goals and achievements.

    Participants will be offered (for free) 4 sessions of recreational soccer instruction on the basics of the program.

    Intervention: Behavioral: mHealth
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 28, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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/m2
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Roberto Felipe Lobelo, MD 770-488-5737 felipelobelo@emory.edu
Contact: Jennifer Frediani, PhD, RD 404-727-3766 jfredia@emory.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04144127
Other Study ID Numbers  ICMJE IRB00110890
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Roberto Felipe Lobelo, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roberto Felipe Lobelo, MD Emory University
PRS Account Emory University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP