Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors (GREENS)

Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors Undergoing Hormone Therapy (GREENS)

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.

Study Overview

• Status: Recruiting
• Conditions: Localized Prostate Carcinoma; Stage II Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Locally Advanced Prostate Carcinoma; Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Biospecimen Collection; Other: Interview; Other: Physical Performance Testing; Other: Medical Device Usage and Evaluation; Procedure: Discussion; Other: Exercise Intervention; Procedure: Physical Examination; Other: Recreational Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Garry Cai; Phone Number: (323)442-3113; Email: Guanrong@usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC / Norris Comprehensive Cancer Center
      • Contact: George Salem, PhD; Phone Number: 323-442-3113; Email: gsalem@usc.edu
      • Principal Investigator: George Salem, PhD
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Los Angeles General Medical Center
      • Contact: George Salem, PhD; Phone Number: 323-442-3113; Email: gsalem@usc.edu
      • Principal Investigator: George Salem, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive care (golf program); Patients participate in the golf training program composed of group sessions over 1-2 hours with a 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.

Other: Questionnaire Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Interview; Ancillary studies; Other: Physical Performance Testing; Ancillary studies; Other Names: Physical Fitness Testing; Physical Function Testing; Other: Medical Device Usage and Evaluation; Wear activity tracker; Procedure: Discussion; Ancillary studies; Other Names: Discuss; Other: Exercise Intervention; Complete golf related exercises; Procedure: Physical Examination; Ancillary studies; Other Names: Assessment; General Examination; Physical; Physical Assessment; Physical Exam; physical_exam; Physical examination procedure (procedure); Other: Recreational Therapy; Participate in golf program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate	Will be defined as the final number of enrolled individuals / the number of qualified individuals screened.	Up to 3 years
Participant adherence to the program	Will be assessed by the number of participants who adhere to the study and attend > 80% of supervised training sessions.	Up to 3 years
Cost of the program	Will be assessed by the cost that the program will be < $1,000/participant.	Up to 3 years
Staff adherence	Will be assessed by trained staff who attend > 90% of scheduled sessions.	Up to 3 years
Program accommodations	Will be defined as the program accommodating course scheduling for > 95% of training sessions.	Up to 3 years
Incidence of adverse events	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).	Up to 3 years
Quality of life scores	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).	Up to 3 years
Circulating inflammatory biomarker levels	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.	Up to 3 years
Senior fitness test scores	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.	Up to 3 years
Gait speed	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.	Up to 3 years
Balance Confidence	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.	Up to 3 years
Cognitive function	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.	Up to 3 years
Participant feedback of the program	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.	Up to 3 years

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: George Salem, PhD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Diagnostic Techniques, Respiratory System; Diagnostic Techniques, Cardiovascular; Behavior Control; Immobilization; Heart Function Tests; Respiratory Function Tests; Ergometry; Interviews as Topic; Specimen Handling; Restraint, Physical; Exercise Test; Recreation Therapy
• Other Study ID Numbers: 4P-23-4 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2023-09213 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No