Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors

NCT06500169 | Recruiting

• 3 other identifiers: 4P-23-4NCI-2023-09213P30CA014089
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Localized Prostate Carcinoma; Locally Advanced Prostate Carcinoma; Stage II Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (1)

Supportive care (golf program)

EXPERIMENTAL

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.

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

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Supportive care (golf program)

Discussion PROCEDURE

Ancillary studies

Also known as: Discuss

Supportive care (golf program)

Exercise Intervention OTHER

Complete golf related exercises

Supportive care (golf program)

Interview OTHER

Ancillary studies

Supportive care (golf program)

Medical Device Usage and Evaluation OTHER

Wear activity tracker

Supportive care (golf program)

Physical Examination PROCEDURE

Ancillary studies

Also known as: Assessment, General Examination, Physical, Physical Assessment, Physical Exam, Physical examination procedure (procedure), physical_exam

Supportive care (golf program)

Physical Performance Testing OTHER

Ancillary studies

Also known as: Physical Fitness Testing, Physical Function Testing

Supportive care (golf program)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (golf program)

Recreational Therapy OTHER

Participate in golf program

Supportive care (golf program)

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Specimen Handling; Interviews as Topic; Restraint, Physical; Exercise Test; Recreation Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• George Salem, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Garry Cai

CONTACT

(323)442-3113; Guanrong@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: July 15, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (2)