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Multimodal Rehabilitation Program to Bladder Cancer Patients (MRPBC)

This study is currently recruiting participants.
Verified October 2012 by University of Aarhus
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01329107
First received: March 10, 2011
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Bladder Cancer
 Behavioral: Multimodal Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of a Multimodal Rehabilitation Program to Bladder Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    • 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:
  • 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 ] [ Designated as safety issue: Yes ]
    • 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


Estimated Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329107

Contacts
Contact: Bente Thoft Jensen, PH.D-STUD 0045 89495918 benjense@rm.dk
Contact: Michael Borre, Professor 0045 89495926 borre@ki.au.dk

Locations
Denmark
Michael Borre Recruiting
Aarhus, Aarhus N, Denmark, 8200
Contact: Bente Thoft Jensen, ph.d.-stud     004578452728     benjense@rm.dk    
Contact: Michael Borre, Professor     004578452728     benjense@rm.dk    
Sub-Investigator: Ingrid Søndergaard, RN            
Sub-Investigator: Berit Kiesbye, ET            
Sub-Investigator: Anne Hauge, ET            
Sub-Investigator: Annemette krintel Petersen, Ph.d.            
Sub-Investigator: Tine Weinrich, Physio.            
Sub-Investigator: Mette Borre, ED            
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Bente Thoft Jensen, MPH/ ph.d.-stud     0045 78452728     benjense@rm.dk    
Contact: Michael Borre, Professor     004578452701     borre@ki.au.dk    
Principal Investigator: Bente Thoft Jensen, Ph.D.-Stud            
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Michael Borre, PH.D University of Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01329107     History of Changes
Other Study ID Numbers: M20100122, Aarhus University
Study First Received: March 10, 2011
Last Updated: October 29, 2012
Health Authority: Denmark: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 19, 2013