Clinical trial NCT06500169: Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors
Official title: Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors Undergoing Hormone Therapy (GREENS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: 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
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-07-15
Enrollment: 20
Sex: MALE
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Enrollment rate
timeFrame: Up to 3 years
measure: Participant adherence to the program
timeFrame: Up to 3 years
measure: Cost of the program
timeFrame: Up to 3 years
measure: Staff adherence
timeFrame: Up to 3 years
measure: Program accommodations
timeFrame: Up to 3 years
measure: Incidence of adverse events
timeFrame: Up to 3 years
measure: Quality of life scores
timeFrame: Up to 3 years
measure: Circulating inflammatory biomarker levels
timeFrame: Up to 3 years
measure: Senior fitness test scores
timeFrame: Up to 3 years
measure: Gait speed
timeFrame: Up to 3 years
measure: Balance Confidence
timeFrame: Up to 3 years
measure: Cognitive function
timeFrame: Up to 3 years
measure: Participant feedback of the program
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles General Medical Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: George Salem, PhD
role: PRINCIPAL_INVESTIGATOR
References: