Bladder cancer patients undergoing radical cystectomy face a life-threatening disease, loss of an important body function and require self-care skills to manage treatment outcomes. Removal of the bladder necessitates diversion of urine via three major procedures, an incontinent stoma; b) a continent urinary reservoir catheterized by the patient; or c) a continent urinary reservoir connected to the urethra to allow for normal voiding. Each of these diversion options has significant side effects and requires specific self-care skills. Urinary diversion decision is difficult and could be influenced by factors including patient's demographic and functional factors (e.g., age, values related to urine control, and kidney function). Unfortunately, decisional tools to help patients with these decisions are lacking. Guided by our prior studies in bladder cancer (NCI- 1R03CA165768-01A1; ACS-121193-MRSG) and prostate cancer patients (NIH, R29CA77372, R01- NR009692), a decisional-based intervention we developed for patients undergoing cystectomy and urinary diversion, and our computerized decisional control and information preference assessments, we aim to: a) develop a personalized, Internet-based, patient-oriented decision-support program (the P3-BC), and b) evaluate its acceptability and feasibility in a randomized, pilot study in 45 patients undergoing radical cystectomy. The P3-BC will be comprised of customized text, illustrations, and video coaching regarding potential outcomes of each diversion option, influential personal factors, and communication with physicians. During the first 6 months, we will develop program content and software using a Joint Application Development (JAD) model that involves both the patient and the developer in the design of the application. Program content will be validated by expert panel review using the JAD methodology in a structured workshop session. The software will be developed and implemented on an existing, generalized, platform and functional use cases built by the collaborating Clinical informatics Research Group for a successful decision making informatics project. The overall usability of the P3-BC tool will be conducted with a convenience sample of 20 users. Usability test results will guide program iterative refinement and finalization. The finalized program will be accessible via the Internet, computer, or Android tablet. During month 7-24, we will conduct a pilot, randomized (P3-BC+usual care (UC) vs. UC only), feasibility study with 45 patients (i.e. n UC = 15 patients; n P3- BC+UC = 30 patients) recruited from Mount Sinai Health System. The primary outcome measures will be the feasibility and acceptability of the P3-BC. Pre-and post-intervention measurements (1 and 3 months thereafter) will explore shared decision making, decisional conflict, psychological distress, and treatment choice, controlling for covariates. An exit brief survey will examine physicians' utility and perceived effectiveness of the P3-BC and shared decision making. We hypothesize that the P3-BC tool will be acceptable and will facilitate shared decision making and communication with providers.
There is a pressing need to develop a personalized, value-based decisional tool for bladder cancer patients undergoing radical cystectomy (bladder removal) and urinary diversion to help them with communication with the physicians, shared decision making, and preparation for disease-management and follow-up care. The proposed intervention, the Personal Patient Profile - Bladder Cancer (P3-BC), will be the first intervention to address these issues. Results of this pilot randomized feasibility study will provide evidence of the feasibility and acceptability of the P3-BC and will guide further refinement of the tool for a larger experimental trial, with potential dissemination of the program via the Internet and hand-held computing devices.
