Physical Therapy in Pre-cystectomy Patients

NCT05978570 | Completed DMC

• 1 other identifier: LCCC2251
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Keywords

radical cystectomy; physical therapy; exercise program

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The proportion of individuals who received a physical therapy consultation

  1 day (the date of cystectomy)

• Ninety-day readmission rates

  Up to 90 days after the date of cystectomy

• Acute care length of stay

  Starting to the exercises to up to 90 days after the date of cystectomy

• Mortality rates

  Up to 90 days after the date of cystectomy

• Post-cystectomy complication types and rates

  Up to 90 days after the date of cystectomy

Study Arms (1)

A personally tailored exercise

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

Eligibility Criteria

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

Study Population

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

You may qualify if:

• Age ≥ 18 years at the time of bladder cancer diagnosis
• History of bladder cancer
• Performance of radical cystectomy

You may not qualify if:

• \. No history of bladder cancer or radical cystectomy

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

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

• Sasha Knowlton

  Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 7, 2023
• Study Start: August 27, 2023
• Primary Completion: April 26, 2024
• Study Completion: June 26, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)