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临床试验/NCT04298827
NCT04298827已完成不适用

Optimizing Prehabilitation in Gynecologic Oncology

St. Louis University2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2020年7月21日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shannon Grabosch, MD

Assistant Professor of Gynecologic Oncology

St. Louis University

研究点 (2)

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