The personal patient profile decision support for patients with bladder cancer

项目摘要 接受根治性膀胱切除术的膀胱癌患者面临着一种危及生命的疾病，失去了重要的 身体功能，并需要自我护理技能来管理治疗结果。切除膀胱是必要的 通过三个主要程序分流尿液：失禁造口术；b)可控性尿液储存库 由患者进行导尿；或c)连接到尿路的可控性储尿器，以允许正常 排尿。每一种转移注意力的方法都有很大的副作用，需要特定的自我护理技能。 尿流改道的决定是困难的，可能会受到包括患者的人口统计和 功能因素(例如，年龄、与尿液控制相关的数值和肾功能)。不幸的是，决定权 缺乏帮助患者做出这些决定的工具。根据我们以前对膀胱癌的研究(NCI- 1R03CA165768-01A1；acs-121193-msg)和前列腺癌患者(美国国立卫生研究院，R29CA77372，R01- NR009692)，我们为接受膀胱切除术和尿路手术的患者开发了一种基于决策的干预措施 我们的计算机决策控制和信息偏好评估，目标是：a) 制定个性化、基于互联网、以患者为导向的决策支持计划(P3-BC)，以及b) 在45例根治术患者的随机先导性研究中评估其可接受性和可行性 膀胱切除术。P3-BC将由定制文本、插图和视频指导组成，内容涉及 每个转移选项的潜在结果，有影响的个人因素，以及与医生的沟通。 在前6个月，我们将使用联合应用程序开发来开发计划内容和软件 (JAD)模型，在应用程序的设计中同时涉及患者和开发人员。节目内容 将在一次有组织的研讨会上利用联合专家小组的方法，通过专家小组审查进行验证。这个 将在现有的通用平台和功能用例上开发和实施软件 由协作的临床信息学研究小组为成功的决策信息学而构建 项目。P3-BC工具的总体可用性将通过20个用户的便利样本进行。 可用性测试结果将指导程序的迭代求精和定稿。最终确定的计划将是 可通过互联网、计算机或Android平板电脑访问。在7-24个月期间，我们将进行一次试点， 随机(P3-BC+常规护理(UC)与仅UC)，对45名患者进行可行性研究(即n UC=15名患者；n P3- BC+UC=30例)，来自西奈山卫生系统。主要结果衡量标准将是 P3-BC的可行性和可接受性。干预前后测量(干预后1个月和3个月) 将探讨共同决策、决策冲突、心理困扰和治疗选择， 控制协变量。退出简要调查将检查医生的效用和感知的有效性 P3-BC和共享决策。我们假设P3-BC工具将被接受，并将促进 与提供商共享决策和沟通。

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 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.