Efficacy of a Multimodal Rehabilitation Program to Bladder Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 129
- Locations
- 4
- Primary Endpoint
- Efficacy of a Multimodal Rehabilitation Program to Bladder Cancer Patients
Study Overview
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
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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)
Outcomes
Primary Outcomes
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 Outcomes
- 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)