Bladder CancerNCT05978570
Physical Therapy in Pre-cystectomy Patients
An observational study of Bladder Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2023to 26 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are with bladder cancer and receiving treatment at the study site.
Who may be able to join
- Age ≥ 18 years at the time of bladder cancer diagnosis
- History of bladder cancer
- Performance of radical cystectomy
Who cannot join
- 1. No history of bladder cancer or radical cystectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
- Conditions
- Bladder Cancer
- Keywords
- radical cystectomy, physical therapy, exercise program
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days after the date of cystectomy
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 90 days after the date of cystectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start27 Aug 2023
- Primary completion26 Apr 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sasha Knowlton, Principal investigator, Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978570
- Sponsor's protocol ID
- LCCC2251
- Status last verified
- Mar 2025
- First submitted
- 28 Jul 2023
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Physical Therapy in the Pre-cystectomy Pathway in Patients With Bladder Cancer on Patient Outcomes
- ClinicalTrials.gov ID
- NCT05978570
- Acronym / sponsor ID
- LCCC2251
- Conditions
- Bladder Cancer
- Keywords
- radical cystectomy, physical therapy, exercise program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 27 Aug 2023 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A personally tailored exercise | – | –A personally tailored exercise program will be offered to the participants after the Physical Therapy assessment, before the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are with bladder cancer and receiving treatment at the study site.
Key inclusion criteria (3 listed)
- Age ≥ 18 years at the time of bladder cancer diagnosis
- History of bladder cancer
- Performance of radical cystectomy
Key exclusion criteria (1 listed)
- 1. No history of bladder cancer or radical cystectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thirty-day readmission rates
Time frame: 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.
5 secondary outcomes
The proportion of individuals who received a physical therapy consultation
Time frame: 1 day (the date of cystectomy)
Ninety-day readmission rates
Time frame: Up to 90 days after the date of cystectomy
Acute care length of stay
Time frame: Starting to the exercises to up to 90 days after the date of cystectomy
Mortality rates
Time frame: Up to 90 days after the date of cystectomy
Post-cystectomy complication types and rates
Time frame: Up to 90 days after the date of cystectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sasha Knowlton principal investigator
Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thirty-day readmission rates (time frame: Up to 30 days after the date of cystectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.