Comprehensive Optimization At-time of Radical Cystectomy Intervention

Bladder Cancer Clinical Trial

— COARC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05714826
• Other study ID #: STU-2022-1221
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2024
• Est. completion date: August 24, 2026

Study information

• Verified date: April 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Jacob Taylor, MD, MPH
• Phone: 781-789-7047
• Email: Jacob.Taylor[@]UTSouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: August 24, 2026
• Est. primary completion date: May 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Bladder Cancer
• Radical Cystectomy
• Urinary Bladder Neoplasms

Intervention

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
• Usual Care
ERAS, Usual referral and recovery care, and Standard follow-up protocol

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90 day complication rate	Number of occurrences of complications at 90 days in patients in post-operative phase	90 days
Secondary	30 day complication rate	Number of occurrences of complications at 30 days in patients in post-operative phase	30 days
Secondary	Readmission rates	Number of readmissions	90 days
Secondary	Adherence to the intervention	It is assessed via patient-self report measure	90 days
Secondary	Changes in functional fitness as measured by step count	Changes in functional fitness will be measured by step count	Baseline, 90 days
Secondary	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