The personal patient profile decision support for patients with bladder cancer

膀胱癌患者的个人患者档案决策支持

• 批准号: 10247811
• 负责人: WILLIAM B LOBER
• 金额: $ 16.45万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10247811
• 关键词: Address; Age; American; Android; BCG Live; Benefits and Risks; Biological; Bladder; Body Image; Cancer Patient; Caring; Catheters; Clinic Visits; Clinical; Clinical Informatics; Communication; Complex; Computer software; Computers; Conflict (Psychology); Congenital Abnormality; Continent Urinary Reservoirs; Custom; Cystectomy; Data; Decision Aid; Decision Making; Development; Devices; Disease; Disease Management; Distress; Educational workshop; Effectiveness; Elements; Ensure; Event; Excision; Face; Feasibility Studies; Female; Goals; Guidelines; Hand; Health; Health system; Hepatic; Impairment; Influentials; Informatics; Internet; Intervention; Joints; Judgment; Kidney; Life; Malignant Neoplasms; Malignant neoplasm of prostate; Malignant neoplasm of urinary bladder; Measurement; Methodology; Methods; Online Systems; Outcome; Outcome Measure; Outcome Study; Participant; Patient Preferences; Patients; Physicians; Pilot Projects; Postoperative Period; Preparation; Procedures; Process; Program Acceptability; Provider; Proxy; Qualitative Research; Quality of life; Questionnaires; Radical Cystectomy; Randomized; Readability; Recurrence; Refractory; Relapse; Renal function; Reporting; Research; Review Literature; Sampling; Self Care; Spinal cord injury; Stomas; Structure; Sum; Surveys; Survivors; System; Tablets; Test Result; Testing; Text; Training; Treatment outcome; United States; United States National Institutes of Health; Urethra; Urinary Diversion; Urine; Visit; acceptability and feasibility; base; care systems; comorbidity; computerized; design; ethnic diversity; experience; follow-up; high risk; improved; intervention participants; literacy; model development; muscle invasive bladder cancer; non-muscle invasive bladder cancer; patient oriented; post intervention; preference; primary outcome; profiles in patients; program dissemination; programs; psychological distress; recruit; satisfaction; secondary outcome; shared decision making; side effect; skills; standard care; tool; treatment arm; treatment as usual; treatment choice; urologic; usability

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.

项目摘要 接受根治性膀胱切除术的膀胱癌患者面临着危及生命的疾病， 身体功能，需要自我护理技能来管理治疗结果。切除膀胱需要 通过三个主要程序将尿分流，失禁造口; B）可控尿储尿器 c）可控的储尿器，其连接到尿道以允许正常的排尿; 排泄这些转移选择中的每一个都有显著的副作用，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学和 功能因素（例如，年龄、与尿控制相关的值和肾功能）。不幸的是，果断 缺乏帮助患者做出这些决定的工具。根据我们先前对膀胱癌的研究（NCI- 1 R 03 CA 165768 - 01 A1; ACS-121193-MRSG）和前列腺癌患者（NIH，R29 CA 77372，R 01 - 01 A1） NR 009692），这是我们为接受膀胱癌和泌尿系统疾病的患者开发的一种基于决策的干预措施。 转移，以及我们的计算机化决策控制和信息偏好评估，我们的目标是： 开发个性化的、基于互联网的、面向患者的决策支持程序（P3-BC），以及B） 在45名接受根治性手术的患者中进行的随机、初步研究中评估其可接受性和可行性 cyclohexane。P3-BC将包括定制的文本，插图和视频辅导， 每种转移选择的潜在结果、有影响力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程序内容和软件。 (JAD)在应用程序的设计中涉及患者和开发人员的模型。节目内容 将在结构化的研讨会上通过专家小组评审，使用JAD方法进行验证。的 将在现有的通用平台和功能用例上开发和实施软件 由合作的临床信息学研究小组建立，用于成功的决策信息学 项目P3-BC工具的总体可用性将以20名用户为方便样本进行测试。 可用性测试结果将指导程序迭代细化和最终确定。最终确定的方案将是 可通过互联网、电脑或Android平板电脑访问。在7-24月，我们将进行试点， 随机化（P3-BC+常规治疗（UC）vs.仅UC），45例患者的可行性研究（即n UC = 15例患者; n P3-BC = 15例患者） BC+UC = 30例患者），从西奈山卫生系统招募。主要结局指标为 P3-BC的可行性和可接受性。干预前和干预后测量（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。退出简短调查将检查医生的效用和感知的有效性， P3-BC和共同决策。我们假设P3-BC工具是可以接受的， 与供应商共享决策和沟通。

项目成果

COVID-19 in patients with and without cancer: Examining differences in patient characteristics and outcomes.

• DOI: 10.46439/cancerbiology.2.019
• 发表时间: 2021
• 期刊: Journal of cancer biology
• 作者: Mohamed NE;Benn EK;Astha V;Shah QN;Gharib Y;Kata HE;Honore-Goltz H;Dovey Z;Kyprianou N;Tewari AK
• 通讯作者: Tewari AK