# The personal patient profile decision support for patients with bladder cancer

> **NIH NIH R21** · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2020 · $303,614

## Abstract

Project Summary
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 effect...

## Key facts

- **NIH application ID:** 10057735
- **Project number:** 1R21NR018942-01A1
- **Recipient organization:** ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
- **Principal Investigator:** WILLIAM B LOBER
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $303,614
- **Award type:** 1
- **Project period:** 2020-09-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10057735

## Citation

> US National Institutes of Health, RePORTER application 10057735, The personal patient profile decision support for patients with bladder cancer (1R21NR018942-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10057735. Licensed CC0.

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