Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors

Not Applicable

Recruiting

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

• Registration Number: NCT06500169
• Lead Sponsor: University of Southern California

Brief 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.

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2024-05-24
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (golf program)	Interview	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.
Supportive care (golf program)	Medical Device Usage and Evaluation	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.
Supportive care (golf program)	Biospecimen Collection	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.
Supportive care (golf program)	Physical Examination	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.
Supportive care (golf program)	Physical Performance Testing	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.
Supportive care (golf program)	Questionnaire Administration	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.
Supportive care (golf program)	Exercise Intervention	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.
Supportive care (golf program)	Recreational Therapy	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.
Supportive care (golf program)	Discussion	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.

Primary Outcome Measures

Name	Time	Method
Staff adherence	Up to 3 years	Will be assessed by trained staff who attend \> 90% of scheduled sessions.
Program accommodations	Up to 3 years	Will be defined as the program accommodating course scheduling for \> 95% of training sessions.
Incidence of adverse events	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).
Circulating inflammatory biomarker levels	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	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.
Cost of the program	Up to 3 years	Will be assessed by the cost that the program will be \< $1,000/participant.
Enrollment rate	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	Up to 3 years	Will be assessed by the number of participants who adhere to the study and attend \> 80% of supervised training sessions.
Quality of life scores	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).
Gait speed	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	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	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	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.

Trial Locations

Locations (2)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Los Angeles General Medical Center; 🇺🇸 Los Angeles, California, United States