Physical Therapy in Pre-cystectomy Patients

Sponsor
UNC Lineberger Comprehensive Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05978570
Collaborator
(none)
75
1
1
10
7.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: A personally tailored exercise program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Assessing the Impact of Physical Therapy in the Pre-cystectomy Pathway in Patients With Bladder Cancer on Patient Outcomes
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: A personally tailored exercise

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

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

    Primary Outcome Measures

    1. Thirty-day readmission rates [Up to 30 days after the date of cystectomy]

      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.

    Secondary Outcome Measures

    1. The proportion of individuals who received a physical therapy consultation [1 day (the date of cystectomy)]

      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.

    2. Ninety-day readmission rates [Up to 90 days after the date of cystectomy]

      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.

    3. Acute care length of stay [Starting to the exercises to up to 90 days after the date of cystectomy]

      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.

    4. Mortality rates [Up to 90 days after the date of cystectomy]

      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.

    5. Post-cystectomy complication types and rates [Up to 90 days after the date of cystectomy]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599

    Sponsors and Collaborators

    • UNC Lineberger Comprehensive Cancer Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    UNC Lineberger Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05978570
    Other Study ID Numbers:
    • LCCC2251
    First Posted:
    Aug 7, 2023
    Last Update Posted:
    Aug 7, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by UNC Lineberger Comprehensive Cancer Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 7, 2023