Novel Approach to Facilitate Decisions in Patients w/ Muscle Invasive Bladder CA

促进肌肉侵袭性膀胱 CA 患者决策的新方法

• 批准号: 8876159
• 负责人: Michael A Diefenbach
• 金额: $ 25.25万
• 依托单位: FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-01 至 2017-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8876159
• 关键词: Address; Adoption; Belief; Benefits and Risks; Bladder; Cancer Advocacy; Cancer Patient; Cancer Survivor; Cisplatin; Clinical Trials; Combination Drug Therapy; Communication; Complex; Consultations; Counseling; Cystectomy; Data; Decision Aid; Decision Making; Development; Disease; Effectiveness; Feasibility Studies; Focus Groups; Goals; Individual; Internet; Knowledge; Malignant Neoplasms; Malignant neoplasm of urinary bladder; Measurement; Medical Oncologist; Meta-Analysis; Modeling; Muscle; Neoadjuvant Therapy; Newly Diagnosed; Oncologist; Online Systems; Operative Surgical Procedures; Pamphlets; Patient Education; Patient risk; Patients; Physicians; Prior Chemotherapy; Probability; Process; Protocols documentation; Public Health; Radical Cystectomy; Randomized Clinical Trials; Randomized Controlled Trials; Recruitment Activity; Recurrence; Research; Resources; Risk; Site; Statistical Models; Structure; Surveys; Survivors; Testing; Training; Universities; Urologist; base; chemotherapy; clinical practice; design; evidence base; expectation; high risk; illness perceptions; improved; innovation; insight; mortality; novel strategies; population based; post intervention; preference; prognostic; public health relevance; risk perception; satisfaction; shared decision making; standard care; tool; uptake; usability

 DESCRIPTION (provided by applicant): Radical cystectomy (RC) is standard treatment for patients with muscle­invasive bladder cancer (MIBC). Level I evidence in the form of two randomized clinical trials and a meta­analysis have demonstrated an improvement in survival with the integration of neoadjuvant cisplatin­based combination chemotherapy (NC). Yet, a recent population­based study demonstrated that only 1.2% of patients receive NC. Barriers to NC uptake are a) a lack of a tool predicting survival benefits with neoadjuvant therapy; and b) lack of evidence­based protocols to communicate complex data about the risks and benefits of such therapy. To address these issues, we have recently developed a model to predict survival in patients with MIBC treated with surgery based on commonly available pre­operative variables. While such a model is the first critical step for decision making, there is a paucity o data on what type of information patients need to make a decision, along with how this individualized prognositic information would be best conveyed and integrated into the patient­physician consultation process. Thus, the specific aims are: Specific Aim 1: To develop and refine a counseling protocol consisting of a web­based risk prediction tool and two educational brochures, one for patients and one for physicians. Two focus groups (FG) will provide insights about MIBC survivors' information needs and preferences. 1 FG with physicians will explore barriers to recommending NC. An Internet survey with physicians through the Bladder Cancer Advocacy Network will identify additional barriers. Results will be incorporated in the content and layout of the educational brochures and the risk prediction tool. Usability of the risk prediction tool and content of the brochures will be evaluated by physicians (Urologists (n=5) and medical oncologists (n=5)) and patients (n = 10). Specific Aim 2a): To train urologists and oncologists in the use of the counseling protocol. During a 30­min training session, physicians will be introduced in the use of the risk­prediction tool and the physician brochure and be educated about appropriate risk communication principles. Aim 2b) To evaluate acceptability and feasibility of the counseling protocol with physicians and MIBC survivors. Newly diagnosed MIBC patients eligible for NC (N = 36), recruited in equal numbers from two study sites (Mount Sinai & Duke University), will participate in the counseling protocol. Pre­ and post­intervention measurements will assess patients' risk perception, satisfaction with patient­physician communication, and decision­ making variables. The present research has the potential to significantly impact and change clinical practice through the integration of a structured risk communication protocol into the patient physician consultation. It is innovative, a it is the first of its kind to combine an evidence­based risk prediction tool with patient educatin into a physician­patient counseling protocol for patients with MIBC.

 描述（由适用提供）：自由基膀胱切除术（RC）是针对肌肉发染症患者（MIBC）患者的标准治疗方法。 I级的证据以两项随机临床试验和荟萃分析的形式表明，随着基于新辅助顺铂的结合化疗（NC）的整合，存活率有所提高。然而，最近的一项基于人群的研究表明，只有1.2％的患者接受NC。 NC吸收的障碍是a）缺乏预测新辅助治疗的生存益处的工具； b）缺乏基于证据的协议来传达有关这种疗法的风险和好处的复杂数据。为了解决这些问题，我们最近开发了一个模型来预测基于常见的术前变量接受手术治疗的MIBC患者的生存。尽管这样的模型是决策的第一步，但对于患者需要做出决定的信息类型的数据很少，以及如何将这种个性化的预测信息最好地传达和整合到患者的介学咨询过程中。这是：具体目的是：具体目的1：制定和完善由基于网络的风险预测工具和两个教育手册组成的咨询协议，一本针对患者，另一个用于医生。两个焦点小组（FG）将提供有关MIBC表面表面的信息需求和偏好的见解。与医生的1 FG将探索推荐NC的障碍。通过膀胱癌倡导网络与医生进行的互联网调查将确定其他障碍。结果将纳入教育手册的内容和布局和风险预测工具。风险预测工具的可用性和小册子的内容将由医生（泌尿科医生（n = 5）和医学肿瘤学家（n = 5））和患者（n = 10）评估。特定目的2a）：培训泌尿科医生和肿瘤学家的使用方案。在30分钟的培训课程中，将在使用风险预测工具和身体手册时引入医生，并接受有关适当风险交流原则的教育。目标2b） 评估与医生和MIBC存活的咨询方案的可接受性和可行性。新诊断的MIBC患者有资格获得NC（n = 36），在两项研究中以相等的数量招募 网站（西奈山和杜克大学）将参加咨询协议。干预前和干预后的测量结果将评估患者的风险感知，对患者沟通的满意度以及决策变量。本研究有可能通过将结构化风险交流方案整合到患者医师咨询中，从而显着影响和改变临床实践。它具有创新性，这是第一个将基于证据的风险预测工具与患者教育蛋白结合到MIBC患者的身体患者咨询方案中的第一个。