Optimizing Prehabilitation in Gynecologic Oncology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Six Minute Walk Test
研究概览
简要总结
Patients will be randomized to a unimodal or trimodal prehabilitation program prior to surgery for known or suspected gynecologic cancer.
详细描述
Prehabilitation generally refers to the act of an intervention prior to a known potentially debilitating event. Usually taking the form of physical therapy prior to surgery, prehabilitation programs have demonstrated success in colorectal, urological, and surgical oncology cases. Patients with a gynecologic oncology diagnosis face an arduous course. Their treatment generally involves a major surgery and is often followed by chemotherapy, radiation, or both.The patient population is generally older in life as the average age for an endometrial or ovarian cancer diagnosis is 63. These patients may already have a lower performance status at baseline deeming their treatment course exponentially more difficult to endure. Women with gynecologic cancer suffer significant mental duress often living in fear of the high rates of recurrence from some of these malignancies suggesting they may benefit from psychologic support and counseling through their treatment.
Given the proven success in other surgical disciplines, we believe that instituting prehabilitation programs should be standard of care. Patients will be randomized to a trimodal approach (physical therapy, nutritional counseling, cognitive behavioral therapy) versus a unimodal intervention (physical therapy) for a formal prehabilitation program. Our primary outcome will be functional return to baseline following surgery with secondary outcomes including items such as quality of life assessments, patient satisfaction, and compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient who will be undergoing a planned surgery for known or presumed gynecologic cancer diagnosis.
排除标准
- •Non-English speaking patients
- •Surgeries done for palliative intent
- •Poor performance status or other inability to participate in physical therapy
结局指标
主要结局
Six Minute Walk Test
时间窗: During the approximate 12 week study period
Patients will have a preoperative physical therapy assessment incorporating standard evaluations of a 6 minute walk test, grip strength, and timed up and go. These will serve as the individual patient's baseline for subsequent comparison after surgery.
Timed Up and Go
时间窗: During the approximate 12 week study period
Patients will have a preoperative physical therapy assessment incorporating standard evaluations of a 6 minute walk test, grip strength, and timed up and go. These will serve as the individual patient's baseline for subsequent comparison after surgery.
Grip Strength
时间窗: During the approximate 12 week study period
Patients will have a preoperative physical therapy assessment incorporating standard evaluations of a 6 minute walk test, grip strength, and timed up and go. These will serve as the individual patient's baseline for subsequent comparison after surgery.
次要结局
- Patient Satisfaction(At the conclusion of the approximate 12 week study period)
- Complication Rates(During the 12 week approximate total study period)
- Treatment Completion(At the conclusion of the 12 week approximate total study period)
- Readmission Rates(During the 8 weeks after surgery (12 week approximate total study period))
- Quality of Life FACT-G Assessment(During the 12 week approximate total study period)
研究者
Shannon Grabosch, MD
Assistant Professor of Gynecologic Oncology
St. Louis University
