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临床试验/NCT01329107
NCT01329107已完成不适用

Efficacy of a Multimodal Rehabilitation Program to Bladder Cancer Patients

University of Aarhus4 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
129
试验地点
4
主要终点
Efficacy of a Multimodal Rehabilitation Program to Bladder Cancer Patients

研究概览

简要总结

The incidence of bladder cancer is increasing. Denmark have approximately 1800 incidence per year. The disease is most frequently in males above the age of 70 years. In invasive bladdercancer surgery including removal of the seak bladder with constructing of a new diversion, is the first line treatment. However the procedure is followed by a high morbidity and convalescence. Extended surgical procedure cause pain, stress-induced metabolism and impaired organ function resulting in postoperative complications impacting on rehabilitation. The combination of extended surgery and the increasing numbers of elderly comorbid patients with invasive bladder cancer challenge professional treatment and care

The aim of the study is to investigate the efficacy of a multiprofessional rehabilitation programme for patients with invasive bladder cancer referred to surgery

Material and Methods The study is a randomised controlled trial. All patients > 18 years referred to radical cystectomy will be eligible for this study. The efficacy is primary expressed by the difference in length of stay(LOS). Secondly by complications, health related quality of life(HRQoL) and patient reported quality of care during hospitalization. The intervention includes precise instructions and educations in intensive pre- and postoperatively exercises and stoma-care, supported by the multiprofessional team.

Perspective It is a national goal to improve cancer care. This study is of critical importance and places great emphasis on the patients perspective and involvement in a successful outcome for participant's and involvement in nutritional support, intensive exercises and stoma care, supported by the multidisciplinary team

详细描述

PhD protocol

Efficacy of Multi-professional Rehabilitation in Patients with Bladder Cancer (offered radical cystectomy)

Bente Thoft Jensen, RN, MPH, research nurse Department of Urology Aarhus University Hospital, Skejby

Supervisors:

Michael Borre, associate professor, DMSc, PhD, Department of Urology, Aarhus University Hosptial, Skejby (head supervisor).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients > 18 years referred to radical cystectomy at the Department of Urology, Aarhus University Hospital, Skejby because of invasive bladder cancer.
  • Must have accepted the operation procedure
  • Must have accepted the pre and post-operative careprogram
  • Patients must be able to read and write in Danish.

排除标准

  • patients with neuro-muscular and cognitive diseases
  • Patients referred because of voidingdysfunctions
  • Patients with general bad condition ( judged by the surgeons)

结局指标

主要结局

Efficacy of a Multimodal Rehabilitation Program to Bladder Cancer Patients

时间窗: 2 yrs. Due to the rate of operation pr week the inclusion will close in the beginning of 2013

* Primary Endpoint is the difference in the length of stay (LOS) between the standard care gruop and the intervention group. * LOS will be measuared when the 7 defined standard discharge criteria are fulfilled. The difference between the primary outcome will be compared and published approximately 12 months after inclusion is closed

次要结局

  • Efficacy of Multimodal Rehabilitation Program to Bladder Cancer Patients(2yrs. Due to the rate of operations pr week the inclusion will close in the beginning of 2013)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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