Exercise Oncology Clinic Pilot Feasibility Trial
2026年8月10日 更新者：Jess S. Gorzelitz
Pilot Feasibility Trial for the Exercise Oncology Clinic in Breast and Gynecologic Oncology Patients
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jess Gorzelitz, PhD, MS
- 电话号码：(319) 467-0849
- 邮箱：jessica-gorzelitz@uiowa.edu
学习地点
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Iowa
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Iowa City、Iowa、美国、52242
- 招聘中
- University of Iowa Health Care
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接触：
- Jess Gorzelitz, PhD, MS
- 电话号码：(319) 467-0849
- 邮箱：jess-gorzelitz@uiowa.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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+
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Supervised, Personalized Exercise Program
The clinic will conduct comprehensive patient assessments, develop personalized exercise programs, and monitor progress through fitness evaluations and wearable devices.
|
Sessions will include both resistance (strength) training and aerobic exercise, delivered under the guidance of trained personnel to ensure appropriate technique, progression, and safety.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recruitment rate calculated as the number of participants enrolled divided by the number approached or referred over the study period.
大体时间：Recruitment period which will start at day 1 through two months
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Recruitment rate will be reported as a proportion (percentage) each month
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Recruitment period which will start at day 1 through two months
|
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Retention rate defined as the proportion of enrolled participants who complete the 12-week intervention and post-intervention assessment.
大体时间：Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
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Retention rate will be reported as a proportion (percentage)
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Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
|
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Adherence to exercise sessions calculated as the number of completed supervised exercise sessions divided by the number of prescribed sessions.
大体时间：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%).
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Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
|
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Completeness of functional testing procedures defined as the proportion of participants with complete baseline and follow-up fitness assessments.
大体时间：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).
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Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Participant satisfaction (e.g., Likert-scale survey items) summarized as means and distributions across response categories.
大体时间：Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
|
Satisfaction survey responses summarized as means and distributions across response categories.
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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)
大体时间：Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
|
Perceived burden survey responses reported descriptively and categorized (low/moderate/high burden)
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Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
|
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Willingness to participate or continue exercise programming reported as proportions (%) endorsing continued participation.
大体时间：Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
|
Proportion of participant endorsement of exercising or continuing exercise programming.
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Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
|
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Participant qualitative feedback (if collected) summarized using brief thematic categorization to identify common facilitators and barriers.
大体时间：Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
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Participant qualitative feedback summarized by brief theme categorization,
|
Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jess Gorzelitz, PhD, MS、University of Iowa
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年8月3日
初级完成 (估计的)
2026年12月15日
研究完成 (估计的)
2027年4月15日
研究注册日期
首次提交
2026年7月31日
首先提交符合 QC 标准的
2026年8月10日
首次发布 (实际的)
2026年8月14日
研究记录更新
最后更新发布 (实际的)
2026年8月14日
上次提交的符合 QC 标准的更新
2026年8月10日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.