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Brief Title: Comprehensive Optimization At-time of Radical Cystectomy Intervention

Comprehensive Optimization At-time of Radical Cystectomy Intervention Through Peri-operative Patient Care Program

INTRODUCTION

  • Org Study ID: STU-2022-1221
  • Secondary ID: N/A
  • NCT ID: NCT05714826
  • Sponsor: University of Texas Southwestern Medical Center

BRIEF SUMMARY

The proposed study is aimed at a comprehensive optimization at-time of radical cystectomy (COARC) intervention that focuses on patient optimization throughout the perioperative continuum, from the pre-operative setting to the post-operative period, among patients undergoing radical cystectomy for bladder cancer. This multi-modal strategy will focus on three phases of care around surgery: the pre-operative, peri-operative, and post-operative phases. The intervention group will focus on multiple areas of patient optimization including remote patient monitoring for the earlier identification of potential complications. The overall study mission is to decrease complication rates after radical cystectomy using this comprehensive approach.

DETAILED DESCRIPTION

The proposed study includes the following-

Part I: Pre-operative period After randomization, patients in the intervention group will be referred to the Perioperative Optimization of Senior Health (POSH) program where they will undergo nutritional, functional, and global health assessment. The POSH team will refer patients as indicated to nutrition, physical medicine and rehabilitation, and other consultants to optimize their preoperative fitness for surgery.

Patients in the intervention group will also receive a Remote Patient Monitoring (RPM) Ipad from ActiCare Health, which will serve as their remote monitoring device and educational tool. At enrollment, they will be asked to complete an initial steps intake using a pedometer that will be provided to them. They will be asked to input vital signs once per week after receiving the Ipad to become familiar with the platform pre-operatively.

At enrollment, patients in both groups will also be asked to complete a patient reported Bladder Cancer Index questionnaire, a survey that tracks quality of life in patients with bladder cancer.

Part II: Perioperative period Both the intervention and control groups will undergo standard of care Enhanced Recover After Surgery (ERAS) bladder cancer protocol, which is a medication and peri-operative management protocol developed by the anesthesia and urology departments specifically for bladder cancer patients undergoing radical cystectomy.

While admitted in the hospital recovering from surgery, patients in the intervention group will automatically receive co-management from the POSH team.

Part III: Post-operative period Both the intervention and the control groups will be followed for 90 days post-operatively. The intervention group will use the RPM Ipad to input vital signs, weight, and pedometer steps 3x/week and on an as needed basis over the follow-up period which will be monitored by the ActiCare Health 24/7 clinical support team. Abnormal parameters will be set so that the UT Southwestern Medical Center clinical care team is alerted to any abnormal values.

  • Overall Status
    Recruiting
  • Start Date
    April 25, 2024
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Bladder Cancer
  • Radical Cystectomy

ELIGIBILITY

Inclusion Criteria:
* Adults equal to or more than 18 years old

- * Diagnosis of bladder cancer with plan to undergo radical cystectomy

- * Agrees to participate in study procedures
Exclusion Criteria:
* Patients undergoing cystectomy for diagnosis other than bladder cancer

- * Do not provide informed consent

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Yair Lotan, MD

Role: Principal Investigator

Affiliation: UT Southwestern Medical Center

Overall Contact

Name: Jacob Taylor, MD, MPH

Phone: 781-789-7047

Email: Jacob.Taylor@UTSouthwestern.edu

LOCATION

Facility Status Contact