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临床试验/NCT04027270
NCT04027270撤回不适用

Pelvic Health and Physical Therapy to Improve Lives of Prostate Cancer Patients

University of Missouri-Columbia2 个研究点 分布在 1 个国家开始时间: 2021年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
International Prostate Symptom Score Change

研究概览

简要总结

Patients will be randomized into standard of care or receiving pre and post operative physical therapy intervention following prostatectomy. Outcome measures will be gathered to assess impact of physical therapy on function and quality of life.

详细描述

This is a prospective, randomized, non-blinded, research study undergoing robotic-assisted laparoscopic prostatectomy at the University of Missouri/Ellis Fischel Hospital. Participants will be randomized in a 1:1 fashion. Data also will be tracked on those who are post-operatively stratified by cancer grade and addition of radiation therapy (XRT) as XRT after surgery is dependent on participant pathology therefore would not be able to be determined in advance.

The study will be broken up into four phases, as described in detail below:

Phase 1:

  • Urologic oncology team will consist of a urologic oncologist/surgeon, urologic nurse, and oncology nurse navigator practicing in a specialty oncology hospital which is part of a large regional hospital network in the Midwest section of the United States. A pelvic health physical therapist will be an additional member of this team practicing primarily in outpatient based clinics affiliated with a with the same large regional hospital network.
  • Enrollment will be offered during first hospital visit with urologic oncology team confirming diagnosis of prostate cancer in and decision for robotic radical prostatectomy. Enrollment goal will be at least 40 men but caps at 100.
  • The capture of participants for enrollment will be limited to a 12 month period.
  • Consent is obtained and the participant is enrolled
  • At the time of enrollment, all participants will have baseline measurements taken to obtain baseline physical assessment, complete baseline quality of life questionnaires, and receive education on exercises to begin as prehabilitation protocol prior to surgical intervention.

o Baseline questionnaires include:

  1. International Prostate Symptom Score (IPSS)
  2. International Index of Erectile Function (IIEF)
  3. National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI)
  4. Pain Visual Analog Scale (VAS)
  5. Beck's Depression Index (BDI)
  6. Bristol Stool Form Scale (BSFS)
  • After obtaining written consent, subjects will be randomized to receive post-operative pelvic health physical therapy (Rehab group) or no post-operative intervention (control).
  • Both groups will be given pre-operative prehabilitative exercise program and education of continence behavioral training.
  • At the time of enrollment, all participants the will receive the same educational packet and home exercise program education from the urologic oncology team.

研究设计

研究类型
Interventional
分配方式
Randomized
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
Male
接受健康志愿者

入选标准

  • - Age greater than or equal to 18 years
  • Men who have prostate cancer (regardless of grade or metastasis)
  • Robotic assisted RALP performed by Urologic Oncologist
  • Fluent in speaking and understanding English

排除标准

  • - Inability to obtain written informed consent
  • Atrioventricular conduction blocks
  • CV instability and concomitant use of alpha agonists or beta blockers
  • Recent myocardial infarction (≤ 6 months ago)
  • Cardiac arrhythmia disorders
  • Stokes-Adams syndrome
  • Wolff-Parkinson-White syndrome
  • Seizure disorders
  • Liver failure or hepatic dysfunction
  • Significant renal disease with a serum creatinine ≥ 2 mg/dl
  • A family history of malignant hyperthermia
  • Current abuse of opioids or documented history of opioid abuse
  • Unavailability for reliable transportation
  • Combined surgical cases that include robotic prostatectomy
  • Non-fluent in English speaking and understanding

结局指标

主要结局

International Prostate Symptom Score Change

时间窗: Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively

Change in IPPS from preoperative through to 18 months post operatively, assessed at intervals

Pain Visual Analog Scale Change

时间窗: Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively

Change in Pain VAS from preoperative through to 18 months post operatively, assessed at intervals

Pelvic Floor Strength Test Change

时间窗: Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively

Change in strength from preoperative through to 18 months post operatively, assessed at intervals

International Index of Erectile Function Change

时间窗: Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively

Change in IIEF from preoperative through to 18 months post operatively, assessed at intervals

National Institute of Health Chronic Prostatitis Symptom Index Change

时间窗: Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively

Change in NIH-CPSI from preoperative through to 18 months post operatively, assessed at intervals

Beck's Depression Index Change

时间窗: Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively

Change in BDI from preoperative through to 18 months post operatively, assessed at intervals

Bristol Stool Scale Change

时间窗: Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively

Change in Bristol Stool Scale from preoperative through to 18 months post operatively, assessed at intervals

次要结局

未报告次要终点

研究者

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

Jennifer Y Stone

Manager, Clinical Rehabilitative Services

University of Missouri-Columbia

研究点 (2)

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