Bladder Cancer Clinical Trial
— COARCOfficial title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
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 |
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