Muscle Invasive Bladder Cancer Quality of Care Initiative: A Two Phased Improvement Protocol

Study ID
STU 052012-044

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Allison Beaver
214-645-8788
allison.beaver@utsouthwestern.edu

Principal Investigator
Yair Lotan

Summary

The study will involve a duel phased format: The first phase will involve retrospective collection of data from the MSKCC database and participating institutions regarding patterns of care for patients with muscle invasive bladder cancer, specifically evaluating the use of peri-operative chemotherapy. The second phase will focus on the reasons of non-compliance to established standards.

Phase 1 - Retrospective review of institutional practice patterns for the care of patients with resectable, non-metastatic muscle invasive bladder cancer from 2003-2005. A de-identified data template will be utilized for data collection. Once retrospective data collection is complete within 3 months, data will be analyzed and reviewed. Outcome variables include: Primary: Rate of use of Peri-operative chemotherapy. Secondary: Rate of cisplatin-based therapy used, number of chemotherapy cycles, neoadjuvant vs. adjuvant administration, adequacy of surgical stagine, lymph node dissection.

Phase 2 - This study does not involve any human interaction. In this prospective phase, data will be pulled from subject files who have previously consented to their data being used for other studies via enrollment into the IRB approved database study: STU032011-187 Each site and amp;apos;s primary investigator will use the MSKCC designed and implemented web-link to prospectively add patients wtih non-metastatic muscle invasive bladder cancer in series and in parallel, and change the entered data should it be necessary. A web based survey system will be developed and implemented within MSKCC, and data storage will be within the centralized encrypted database. A senior programming analyst is currently employed as part of our team at MSKCC for this purpose and will be utilizing Microsoft SQL2005 Database for storage and Microsoft Visual Studio 2005 for the web design interface. Outcome variables include: Primary: Raste of peri-operative chemotherapy use. Secondary: Reasons for non-compliance and practice variations, rates of cisplatin chemotherapy usage, number of cycles used, and to determine the change in compliance based on the intiation of quality of care indicators.


Participant Eligibility

The population of interest is those who are candidates for operative management (radical cystectomy) and clinical stage T2-4N0M0.. This study does not include any human interaction. All subject data to be used for the prospective phase of this study will be pulled from subject files who have previously consented to their data being used for another study via enrollment into the IRB approved database study STU 032011-187.