Physical Therapy in Pre-cystectomy Patients

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

This single-site, non-randomized, 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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Other: A personally tailored exercise program

• Study Type: Observational
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who are with bladder cancer and receiving treatment at the study site.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
A personally tailored exercise; A personally tailored exercise program will be offered to the participants after the Physical Therapy assessment, before the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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
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

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Sasha Knowlton, Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill

Publications and helpful links

Helpful Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2023
• Primary Completion (Actual): April 26, 2024
• Study Completion (Actual): June 26, 2024

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: physical therapy; radical cystectomy; exercise program
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: LCCC2251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No