Multimodal Rehabilitation Program to Bladder Cancer Patients

NCT01329107 | Completed DMC

• 2 other identifiers: M20100122Aarhus University
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 2

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

Conditions

Bladder Cancer

Keywords

Rehabilitation; Enhanced Recovery; Health related Qouality of Life; Patient outcomes

Outcome Measures

Primary Outcomes (1)

• Efficacy of a Multimodal Rehabilitation Program to Bladder Cancer Patients

  * 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

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

Secondary Outcomes (1)

• 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

Study Arms (2)

No intervention

NO INTERVENTION

Standard Care

Multimodal intervention

EXPERIMENTAL

Intervention group will be assigned to specific decribed multimodal intervention

Behavioral: Multimodal Intervention

Interventions

Multimodal Intervention BEHAVIORAL

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.

Also known as: Enhanced care programme, Fasttrack pathways

Multimodal intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (2)

Michael Borre

Aarhus, Aarhus N, 8200, Denmark

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Michael Borre, PH.D

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: April 5, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

DK (2)