Physical Therapy in Pre-cystectomy Patients

Bladder Cancer Clinical Trial

Official title:

Assessing the Impact of Physical Therapy in the Pre-cystectomy Pathway in Patients With Bladder Cancer on Patient Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978570
• Other study ID #: LCCC2251
• Status: Recruiting
• Phase: N/A
• Start date: August 27, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Sasha Knowlton
• Phone: 984 974 0293
• Email: sknow[@]email.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This single-site, non-randomized, interventional study evaluates the impact of a physical therapy consultation for patients with bladder cancer scheduled for radical cystectomy (RC). The purpose of this study is to investigate whether consultation with a physical therapist and the development of a personally tailored exercise program in the pre-cystectomy period for patients with bladder cancer will result in reduced post-operative complications, morbidity, length of inpatient stay, improve readmission 30-day and 90-day and improve 90-day mortality. This study will be partially retrospective (pre-implementation of a physical therapy consultation order) and partially prospective.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

In order to participate in this study a subject must meet all of the eligibility criteria outlined below:

Inclusion Criteria:

1. Age = 18 years at the time of bladder cancer diagnosis

2. History of bladder cancer

3. Performance of radical cystectomy

Exclusion Criteria:

1. No history of bladder cancer or radical cystectomy

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• A personally tailored exercise program
A personally tailored exercise program will be offered to the participants after Physical Therapy assessment, before the surgery.

Locations

Country	Name	City	State
United States	Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thirty-day readmission rates	Thirty-day readmission rates will be defined as the comparison of the number of hospital admission after physical therapy consultation and tailored exercises and historical hospital admission data.	Up to 30 days after the date of cystectomy
Secondary	The proportion of individuals who received a physical therapy consultation	The feasibility of implementing a physical therapy consultation and tailored exercise program in the pre-cystectomy treatment pathway will be determined by calculating the proportion of individuals who received a physical therapy consultation in the prospective group.	1 day (the date of cystectomy)
Secondary	Ninety-day readmission rates	Ninety-day readmission rates will be defined as the comparison of the number of hospital admission after physical therapy consultation and tailored exercises and historical hospital admission data.	Up to 90 days after the date of cystectomy
Secondary	Acute care length of stay	Acute care length of stay will be defined as comparing number of hospital day stay after physical therapy consultation and tailored exercises and historical hospital admission data.	Starting to the exercises to up to 90 days after the date of cystectomy
Secondary	Mortality rates	Mortality rates will be defined as the comparison of the number of subjects who died after physical therapy consultation and tailored exercises and historical hospital admission data.	Up to 90 days after the date of cystectomy
Secondary	Post-cystectomy complication types and rates	Post-cystectomy complication types and rates will be defined as comparison of the numbers and types of complications after physical therapy consultation with tailored exercises and historical data.	Up to 90 days after the date of cystectomy

External Links

•   University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials