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Recruiting NCT06500169

Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors

No phase Interventional Localized Prostate Carcinoma Locally Advanced Prostate Carcinoma Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8 Stage II Prostate Cancer AJCC v8

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biospecimen Collection, Discussion, Exercise Intervention, Interview.
Who it may be relevant to
Registry 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. Basic parameters: 55 years — 85 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure Biospecimen Collection
    Undergo blood sample collection
  • Procedure Discussion
    Ancillary studies
  • Other Exercise Intervention
    Complete golf related exercises
  • Other Interview
    Ancillary studies
  • Other Medical Device Usage and Evaluation
    Wear activity tracker
  • Procedure Physical Examination
    Ancillary studies
  • Other Physical Performance Testing
    Ancillary studies
  • Other Questionnaire Administration
    Ancillary studies
  • Other Recreational Therapy
    Participate in golf program

Primary outcome measures

  • Enrollment rate [Time frame: Up to 3 years]
  • Participant adherence to the program [Time frame: Up to 3 years]
  • Cost of the program [Time frame: Up to 3 years]
  • Staff adherence [Time frame: Up to 3 years]
  • Program accommodations [Time frame: Up to 3 years]
  • Incidence of adverse events [Time frame: Up to 3 years]
  • Quality of life scores [Time frame: Up to 3 years]
  • Circulating inflammatory biomarker levels [Time frame: Up to 3 years]
  • Senior fitness test scores [Time frame: Up to 3 years]
  • Gait speed [Time frame: Up to 3 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 2 centers
  • Los Angeles General Medical Center — Los Angeles
  • USC / Norris Comprehensive Cancer Center — Los Angeles

Identifiers

NCT: NCT06500169 · 4P-23-4 · NCI-2023-09213 · 4P-23-4 · P30CA014089

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗