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Completed

NCT Number: NCT05978570

Physical Therapy in Pre-cystectomy Patients

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • No history of bladder cancer or radical cystectomy

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. The proportion of individuals who received a physical therapy consultation

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2023
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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