Multimodal Rehabilitation Program to Bladder Cancer Patients (MRPBC)
|ClinicalTrials.gov Identifier: NCT01329107|
Recruitment Status : Completed
First Posted : April 5, 2011
Last Update Posted : August 7, 2013
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
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Behavioral: Multimodal Intervention||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy of a Multimodal Rehabilitation Program to Bladder Cancer Patients|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
No Intervention: No intervention
Experimental: Multimodal intervention
Intervention group will be assigned to specific decribed multimodal intervention
Behavioral: Multimodal Intervention
Patients in the intervention group will be taught to manage their new urinary diversion BEFORE operation. Traing kit will be provided so they can train the procedure forehanded. Second they will get a personally physical training program to optimize the total body function before operation. Nutritional status will be meassured and appropriate advices will be given BEFORE operation.
After operation the intervention group will be mobilised in a fast speed compared to standard care.
- Efficacy of a Multimodal Rehabilitation Program to Bladder Cancer Patients [ Time Frame: 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
- Efficacy of Multimodal Rehabilitation Program to Bladder Cancer Patients [ Time Frame: 2yrs. Due to the rate of operations pr week the inclusion will close in the beginning of 2013 ]
- HeQoL will be measured at baseline and 120 days postoperatively.( EORTC questionaire)
- Complications postoperatively will be meassured at discharge and at 120 days postoperatively with the listed domaines on the Memorial Sloan Kettering Tool.
- Management of the urinary diversion will be measured on a patient stoma skill score ( baseline, before operation, +35 days and at 120 days)
- All outcomes is expected to be published in 12 months on average after operation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329107
|Aarhus, Aarhus N, Denmark, 8200|
|Aarhus University Hospital|
|Aarhus, Denmark, 8200|
|Principal Investigator:||Michael Borre, PH.D||University of Aarhus|