Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors
NCT Number: NCT06500169
Acronym: GREENS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: 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
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
Sponsor: University of Southern California
Collaborators: National Cancer Institute (NCI)
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-09-01
Completion Date: 2027-09-01
Locations: Los Angeles General Medical Center, Los Angeles, California, 90033, United States|USC / Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States

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.

Primary Outcome Measures: 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