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Clinical Trial NCT05714826 (COARC) for Bladder Cancer, Radical Cystectomy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University of Texas Southwestern Medical CenterComprehensive Optimization At-time of Radical Cystectomy Intervention (COARC) 194 Remote
Clinical Trial NCT05714826 (COARC) is an interventional study for Bladder Cancer, Radical Cystectomy that is recruiting. It started on 25 April 2024 with plans to enroll 194 participants. Led by University of Texas Southwestern Medical Center, it is expected to complete by 24 August 2026. The latest data from ClinicalTrials.gov was last updated on 2 May 2025.
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-opera...Show More
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 optim...
Show MoreOfficial Title
Comprehensive Optimization At-time of Radical Cystectomy Intervention Through Peri-operative Patient Care Program
Conditions
Bladder CancerRadical CystectomyOther Study IDs
- COARC
- STU-2022-1221
NCT ID Number
Start Date (Actual)
2024-04-25
Last Update Posted
2025-05-02
Completion Date (Estimated)
2026-08-24
Enrollment (Estimated)
194
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Peri-operative
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalIntervention 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 | 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 |
Active ComparatorControl Arm Enhanced Recovery After Surgery Usual referral and recovery care as needed Standard follow-up protocol | Usual Care ERAS, Usual referral and recovery care, and Standard follow-up protocol |
Primary Outcome Measures
Secondary 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 |
| 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- Patients undergoing cystectomy for diagnosis other than bladder cancer
- Do not provide informed consent
University of Texas Southwestern Medical Center284 active studies to exploreStudy Responsible Party
yair lotan, Principal Investigator, Professor, University of Texas Southwestern Medical Center
Study Central Contact
Contact: Jacob Taylor, MD, MPH, 781-789-7047, [email protected]
1 Study Locations in 1 Countries
Texas
University of Texas Southwestern Medical Center, Dallas, Texas, 75390-9164, United States
Sonobia Garrett, Contact, 2146458482, [email protected]
Holly L Ford, Contact, 2146458790, [email protected]
Recruiting