Pilot Feasibility Trial for the Exercise Oncology Clinic in Breast and Gynecologic Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment rate calculated as the number of participants enrolled divided by the number approached or referred over the study period.
研究概览
简要总结
The purpose of this pilot study is to test a supervised exercise program for adults with a history of breast or gynecologic cancer to see if it is safe, helpful, and easy to take part in.
详细描述
This pilot study will enroll up to 30 adult cancer patients to participate in a structured exercise oncology clinic to evaluate and refine clinical procedures for individualized exercise assessment and prescription. The study is designed to generate preliminary data on the feasibility, acceptability, and safety of implementing a supervised exercise program integrated into oncology care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Confirmed diagnosis of breast or gynecologic cancer (any stage)
- •Willingness to participate in the exercise oncology program and associated research procedures Ability to provide informed consent
- •Clearance to participate in exercise as determined by completion of the Physical Activity Readiness Questionnaire Plus (PAR-Q+) and any additional clinical screening as needed
排除标准
- •Presence of absolute contraindications to exercise (e.g., unstable cardiovascular disease, acute illness, or other conditions that preclude safe participation in physical activity)
- •Determination by a referring or treating healthcare provider that the patient is not appropriate for exercise participation at the time of screening
- •Inability to complete required screening procedures, including the PAR-Q+
研究组 & 干预措施
Supervised, Personalized Exercise Program
The clinic will conduct comprehensive patient assessments, develop personalized exercise programs, and monitor progress through fitness evaluations and wearable devices.
干预措施: Supervised, Personalized Exercise Program (Other)
结局指标
主要结局
Recruitment rate calculated as the number of participants enrolled divided by the number approached or referred over the study period.
时间窗: Recruitment period which will start at day 1 through two months
Recruitment rate will be reported as a proportion (percentage) each month
Retention rate defined as the proportion of enrolled participants who complete the 12-week intervention and post-intervention assessment.
时间窗: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
Retention rate will be reported as a proportion (percentage)
Adherence to exercise sessions calculated as the number of completed supervised exercise sessions divided by the number of prescribed sessions.
时间窗: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
Summarized as mean adherence (%) and proportion meeting predefined adherence thresholds (e.g., \>70%;\>80%).
Completeness of functional testing procedures defined as the proportion of participants with complete baseline and follow-up fitness assessments.
时间窗: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
All feasibility outcomes will be summarized using descriptive statistics (means, standard deviations, medians, ranges, and proportions with 95% confidence intervals where appropriate).
次要结局
- Participant satisfaction (e.g., Likert-scale survey items) summarized as means and distributions across response categories.(Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks)
- Participant perceived burden (e.g., time, effort, difficulty) reported descriptively and categorized (low/moderate/high burden)(Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks)
- Willingness to participate or continue exercise programming reported as proportions (%) endorsing continued participation.(Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks)
- Participant qualitative feedback (if collected) summarized using brief thematic categorization to identify common facilitators and barriers.(Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks)
研究者
Jess S. Gorzelitz
Assistant Professor
University of Iowa