Comprehensive Optimization At-time of Radical Cystectomy Intervention (COARC)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Bladder Cancer; Radical Cystectomy
• Intervention / Treatment: Other: Preop Intervention and Monitored Recovery; Other: Usual Care

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390-9164
      • Recruiting
      • University of Texas Southwestern Medical Center
      • Contact: Holly L Ford; Phone Number: 2146458790; Email: holly.ford@utsouthwestern.edu
      • Contact: Sonobia Garrett; Phone Number: 2146458482; Email: Sonobia.Garrett@UTSouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Preop intervention Arm Referral to Perioperative Optimization of Senior Health (POSH) Program Remote patient monitoring device orientation, initial intake, and education UTSW ERAS protocol perioperatively Inpatient geriatrics co-management Monitored recovery Post-operative monitoring with Acticare for 90 days Post-op specialist continuity of care	Other: Preop Intervention and Monitored Recovery; Perioperative Optimization of Senior Health (POSH) Program; patient monitoring by device orientation, initial intake, education; ERAS protocol, inpatient geriatric co-management; and remote monitoring with Acticare device; post-op continuity of care; Other Names: Monitored recovery during post-operative phase
Active Comparator: Control Arm; Enhanced Recovery After Surgery Usual referral and recovery care as needed Standard follow-up protocol	Other: Usual Care; ERAS, Usual referral and recovery care, and Standard follow-up protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90 day complication rate	Number of occurrences of complications at 90 days in patients in post-operative phase	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 day complication rate	Number of occurrences of complications at 30 days in patients in post-operative phase	30 days
Readmission rates	Number of readmissions	90 days
Adherence to the intervention	It is assessed via patient-self report measure	90 days
Changes in functional fitness as measured by step count	Changes in functional fitness will be measured by step count	Baseline, 90 days
QOL changes as measured by the Bladder Cancer Index and FACT-Bl-Cys Questionnaire measures	Changes in patient reported outcomes will be measured by QOL (Bladder Cancer Index questionnaire). Possible scores range from 0-100, where higher scores indicate better HRQOL outcome. Changes will also be measured using the FACT-Bl-Cys tool to assess changes in bladder related quality of life in patients undergoing cystectomy over the course of the study.	Baseline, 90 days

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Yair Lotan, MD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): August 24, 2026

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Peri-operative
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: STU-2022-1221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No