Trial Title:
Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors
NCT ID:
NCT06500169
Condition:
Localized Prostate Carcinoma
Locally Advanced Prostate Carcinoma
Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8
Stage II Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Conditions: Official terms:
Carcinoma
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Supportive care (golf program)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Discussion
Description:
Ancillary studies
Arm group label:
Supportive care (golf program)
Other name:
Discuss
Intervention type:
Other
Intervention name:
Exercise Intervention
Description:
Complete golf related exercises
Arm group label:
Supportive care (golf program)
Intervention type:
Other
Intervention name:
Interview
Description:
Ancillary studies
Arm group label:
Supportive care (golf program)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear activity tracker
Arm group label:
Supportive care (golf program)
Intervention type:
Procedure
Intervention name:
Physical Examination
Description:
Ancillary studies
Arm group label:
Supportive care (golf program)
Other name:
Assessment
Other name:
General Examination
Other name:
Physical
Other name:
Physical Assessment
Other name:
Physical Exam
Other name:
Physical examination procedure (procedure)
Other name:
physical_exam
Intervention type:
Other
Intervention name:
Physical Performance Testing
Description:
Ancillary studies
Arm group label:
Supportive care (golf program)
Other name:
Physical Fitness Testing
Other name:
Physical Function Testing
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Supportive care (golf program)
Intervention type:
Other
Intervention name:
Recreational Therapy
Description:
Participate in golf program
Arm group label:
Supportive care (golf program)
Summary:
This clinical trial evaluates a golf recreational exercise program for enhancing
survivorship in underrepresented prostate cancer survivors. Golf is a multimodal
recreational activity that requires participants to utilize all muscle groups to perform
the golf swing, walk over hilly and uneven terrain, maintain balance during putting and
squat-like tasks. Physical activity and exercise are beneficial to physical function,
cognitive function, psychosocial health, and overall quality of life during prostate
cancer survivorship. These aspects of health are impacted by prostate cancer treatment,
especially androgen deprivation therapy. Additionally, supervised, group-based activity
programs facilitate participation in physical activity. Researchers want to examine the
changes in functional abilities, psychosocial health, and quality of life following
participation in in a golf program designed for prostate cancer survivors.
Detailed description:
PRIMARY OBJECTIVES:
I. To recruit, screen, and enroll prostate cancer survivors. II. To examine the safety,
feasibility, and adherence, of the 10-week (wk) GREENS program.
III. To analyze the pre-post intervention data and examine the effects (assessed by
Hedges g) of the program on:
IIIa. Physical capacity; IIIb. Psychosocial wellness; IIIc. Health, and; IIId. Cognition.
OUTLINE:
Patients participate in the golf training program composed of group sessions over 1-2
hours with a Professional Golfers' Association of America (PGA) professional two times
per week for ten weeks. Training consists of complimentary/warm up exercises integrated
with pelvic floor muscle training, golf instruction, golf practice, and golf play on a
Par 3 public golf course. Patients also wear an activity tracker and undergo blood sample
collection on the study.
After completion of study intervention, patients are followed up at 6 months.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- First time, primary diagnosis of prostate cancer (PCa)
- Currently receiving androgen deprivation therapy (ADT) and/or androgen receptor
blocker) for more than 6 months
- Older adult male: 55-85 years old
- The ability to stand independently without external support
- No or minimal golf experience (played < 5 times in the past 10 years)
- English speaking
Exclusion Criteria:
- Second cancer diagnosis (excluding non-invasive skin cancers) or bone metastases
- Prostatectomy less than 6 months prior to study enrollment (prostatectomy is not a
requirement for study entry)
- Symptomatic cardiovascular disease, active angina, uncontrolled hypertension
(systolic blood pressure (SBP) > 160 or diastolic blood pressure (DBP) > 90, high
resting pulse heart rate (HR) > 90), symptomatic orthostatic hypotension
- Unstable asthma, exacerbated chronic obstructive pulmonary disease (COPD]
- History of injury or orthopedic operation within the last 6 months
- Movement disorders (e.g., Parkinson's disease (PD) or other neurological disorders),
hemiparesis or paraparesis
- Severe vision or hearing problems
Gender:
Male
Minimum age:
55 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Los Angeles General Medical Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
George Salem, PhD
Phone:
323-442-3113
Email:
gsalem@usc.edu
Investigator:
Last name:
George Salem, PhD
Email:
Principal Investigator
Facility:
Name:
USC / Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
George Salem, PhD
Phone:
323-442-3113
Email:
gsalem@usc.edu
Investigator:
Last name:
George Salem, PhD
Email:
Principal Investigator
Start date:
September 1, 2023
Completion date:
September 1, 2027
Lead sponsor:
Agency:
University of Southern California
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Southern California
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06500169
