NCT06500169 · University of Southern California
Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors
(GREENS)
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Discussion
Ancillary studies
OTHER
Exercise Intervention
Complete golf related exercises
OTHER
Interview
Ancillary studies
OTHER
Medical Device Usage and Evaluation
Wear activity tracker
PROCEDURE
Physical Examination
Ancillary studies
OTHER
Physical Performance Testing
Ancillary studies
OTHER
Questionnaire Administration
Ancillary studies
OTHER
Recreational Therapy
Participate in golf program
Primary outcome measures
Enrollment rate
Time frame: Up to 3 years
Will be defined as the final number of enrolled individuals / the number of qualified individuals screened.
Participant adherence to the program
Time frame: Up to 3 years
Will be assessed by the number of participants who adhere to the study and attend \> 80% of supervised training sessions.
Cost of the program
Time frame: Up to 3 years
Will be assessed by the cost that the program will be \< $1,000/participant.
Staff adherence
Time frame: Up to 3 years
Will be assessed by trained staff who attend \> 90% of scheduled sessions.
Program accommodations
Time frame: Up to 3 years
Will be defined as the program accommodating course scheduling for \> 95% of training sessions.
Incidence of adverse events
Time frame: Up to 3 years
Will be assessed across all participants, and defined by less than 3 program-related adverse events (AEs) and any/all AEs will be mild (grade 3 or below according to Common Terminology Criteria for Adverse Events version 5).
Quality of life scores
Time frame: Up to 3 years
Will be assessed by the Functional Assessment of Cancer Therapy - Prostate (FACT-P), a 39-item self-reported questionnaire. FACT-P scores range from 0 to 156, with higher scores indicating a better quality of life. It is expected that the scores will improve with medium to large effect sizes and exceed the established minimal clinically important difference (MCID).
Circulating inflammatory biomarker levels
Time frame: Up to 3 years
Will be assessed by C-reactive protein and tumor necrosis factor alpha (TNFa) which are indicators of inflammation. Based on prior study, C-reactive protein and TNFa levels are expected to decrease with medium to large effect sizes and exceed the calculated MCID levels.
Senior fitness test scores
Time frame: Up to 3 years
Will be assessed by Short physical performance battery (SPPB). The SPPB is scored out of 12 points and higher score indicates better performance. The SPPB is a reliable (intraclass correlation coefficient \[ICC\] was between 0.82-0.92) and validated (MDC=2; MCID=1-3) measure for physical capacity in community-dwelling and clinical older adults.
Gait speed
Time frame: Up to 3 years
Will be assessed with self-selected gait and fast gait using a 10-feet designated walkway and timing device. Faster gait speeds in both condition indicate higher physical capacity. For reference, men in the 60-65 years age group, gait speeds over 1.53 m/s is considered above 80th percentile.
Balance Confidence
Time frame: Up to 3 years
Will be assessed by Activities-specific Balance Confidence (ABC) scale, a 16-item self-reported questionnaire. The ABC is scored from 0% to 100%, where higher scores indicate greater confidence in maintaining balance during activities.
Cognitive function
Time frame: Up to 3 years
Will be assessed by the Food and Drug Administration approved Sway Medical application (app) designed to assess cognition with a smart phone device and will be used to assess cognitive function. The app includes validated tests for processing speed, sensory processing, neuromotor response speed, inhibition, memory, and executive function, which are areas of cognitive function that are potentially influenced by prostate cancer treatments. The app has established normative values for different age group and will be used as reference.
Participant feedback of the program
Time frame: Up to 3 years
Will be assessed by a semi-structured focus group that will be conducted post intervention where participants will be asked about positive affect and negative affect associated with the intervention, their perceived mastery of different components of golf (i.e. putting, chipping, golf swing, etiquette, rules, etc.), facilitators and barriers that pertained to their participation in the intervention. These assessments will provide information unique to prostate cancer survivors and be used directly to improve the protocol and intervention design for future studies in this population. The facilitators and barriers will also be compared to established ones reported by Sattar et al. to qualitatively assess whether they are similar with our diverse cohort of minority participants located in Los Angeles, California.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations