Back to resultsPhysical Therapy in Pre-cystectomy Patients
Primary Purpose
Bladder Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A personally tailored exercise program
Sponsored by
About this trial
This is an interventional supportive care trial for Bladder Cancer focused on measuring radical cystectomy, physical therapy, exercise program
Eligibility Criteria
In order to participate in this study a subject must meet all of the eligibility criteria outlined below: Inclusion Criteria: Age ≥ 18 years at the time of bladder cancer diagnosis History of bladder cancer Performance of radical cystectomy Exclusion Criteria: 1. No history of bladder cancer or radical cystectomy
Sites / Locations
- Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel HillRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A personally tailored exercise
Arm Description
A personally tailored exercise program will be offered to the participants after the Physical Therapy assessment, before the surgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05978570
First Posted
July 28, 2023
Last Updated
August 28, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05978570
Brief Title
Physical Therapy in Pre-cystectomy Patients
Official Title
Assessing the Impact of Physical Therapy in the Pre-cystectomy Pathway in Patients With Bladder Cancer on Patient Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
radical cystectomy, physical therapy, exercise program
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A personally tailored exercise
Arm Type
Experimental
Arm Description
A personally tailored exercise program will be offered to the participants after the Physical Therapy assessment, before the surgery.
Intervention Type
Other
Intervention Name(s)
A personally tailored exercise program
Other Intervention Name(s)
Exercise
Intervention Description
A personally tailored exercise program will be offered to the participants after Physical Therapy assessment, before the surgery.
Primary Outcome Measure Information:
Title
Thirty-day readmission rates
Description
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.
Time Frame
Up to 30 days after the date of cystectomy
Secondary Outcome Measure Information:
Title
The proportion of individuals who received a physical therapy consultation
Description
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.
Time Frame
1 day (the date of cystectomy)
Title
Ninety-day readmission rates
Description
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.
Time Frame
Up to 90 days after the date of cystectomy
Title
Acute care length of stay
Description
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.
Time Frame
Starting to the exercises to up to 90 days after the date of cystectomy
Title
Mortality rates
Description
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.
Time Frame
Up to 90 days after the date of cystectomy
Title
Post-cystectomy complication types and rates
Description
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.
Time Frame
Up to 90 days after the date of cystectomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
In order to participate in this study a subject must meet all of the eligibility criteria outlined below:
Inclusion Criteria:
Age ≥ 18 years at the time of bladder cancer diagnosis
History of bladder cancer
Performance of radical cystectomy
Exclusion Criteria:
1. No history of bladder cancer or radical cystectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sasha Knowlton
Phone
984 974 0293
Email
sknow@email.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sasha Knowlton
Organizational Affiliation
Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasha Knowlton
First Name & Middle Initial & Last Name & Degree
Sasha E Knowlton, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
Description
University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Learn more about this trial
Physical Therapy in Pre-cystectomy Patients
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