Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Biospecimen Collection, Discussion, Exercise Intervention, Interview.
- Кому может быть актуально
- Состояния в реестре: Localized Prostate Carcinoma, Locally Advanced Prostate Carcinoma, Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage II Prostate Cancer AJCC v8. Базовые параметры: 55 лет — 85 лет · Мужчины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors Undergoing Hormone Therapy (GREENS)
Обзор
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.
Подробное описание
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.
Вмешательства
- Процедура Biospecimen Collection
Undergo blood sample collection - Процедура Discussion
Ancillary studies - Другое Exercise Intervention
Complete golf related exercises - Другое Interview
Ancillary studies - Другое Medical Device Usage and Evaluation
Wear activity tracker - Процедура Physical Examination
Ancillary studies - Другое Physical Performance Testing
Ancillary studies - Другое Questionnaire Administration
Ancillary studies - Другое Recreational Therapy
Participate in golf program
Первичные конечные точки
- Enrollment rate [Срок оценки: Up to 3 years]
- Participant adherence to the program [Срок оценки: Up to 3 years]
- Cost of the program [Срок оценки: Up to 3 years]
- Staff adherence [Срок оценки: Up to 3 years]
- Program accommodations [Срок оценки: Up to 3 years]
- Incidence of adverse events [Срок оценки: Up to 3 years]
- Quality of life scores [Срок оценки: Up to 3 years]
- Circulating inflammatory biomarker levels [Срок оценки: Up to 3 years]
- Senior fitness test scores [Срок оценки: Up to 3 years]
- Gait speed [Срок оценки: Up to 3 years]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 2 центра
- Los Angeles General Medical Center — Los Angeles
- USC / Norris Comprehensive Cancer Center — Los Angeles
Идентификаторы
NCT: NCT06500169 · 4P-23-4 · NCI-2023-09213 · 4P-23-4 · P30CA014089