Multimodal Rehabilitation Program to Bladder Cancer Patients (MRPBC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01329107
Recruitment Status : Completed
First Posted : April 5, 2011
Last Update Posted : August 7, 2013
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: No intervention
Standard Care
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.

Other Names:
  • Enhanced care programme
  • Fasttrack pathways

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01329107

Michael Borre
Aarhus, Aarhus N, Denmark, 8200
Aarhus University Hospital
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Principal Investigator: Michael Borre, PH.D University of Aarhus

Responsible Party: University of Aarhus Identifier: NCT01329107     History of Changes
Other Study ID Numbers: M20100122
Aarhus University ( Other Grant/Funding Number: Aarhus University )
First Posted: April 5, 2011    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013

Keywords provided by University of Aarhus:
Enhanced Recovery
Health related Qouality of Life
Patient outcomes

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases