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

 描述（由申请人提供）：根治性膀胱癌（RC）是肌层浸润性膀胱癌（MIBC）患者的标准治疗。 两项随机临床试验和一项Meta分析的I级证据表明，新辅助顺铂联合化疗（NC）可改善生存率。 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摄取的障碍是a）缺乏预测新辅助治疗的生存益处的工具;和B）缺乏基于证据的方案来传达关于这种治疗的风险和益处的复杂数据。 为了解决这些问题，我们最近开发了一个模型，根据常用的术前变量预测手术治疗MIBC患者的生存率。 虽然这样的模型是决策的第一个关键步骤，但关于患者需要什么类型的信息来做出决定，以及如何最好地传达和整合这种个性化预后信息的数据却很少。患者与医生的咨询过程。沿着。 因此，具体目标是：具体目标1：制定和完善一个咨询协议，包括一个基于网络的风险预测工具和两个教育手册，一个是病人，一个是医生。两个焦点小组（FG）将提供有关MIBC幸存者的信息需求和偏好的见解。 1 FG与医生将探讨推荐NC的障碍。通过膀胱癌宣传网络与医生进行的互联网调查将确定其他障碍。 评估结果将纳入教育手册和风险预测工具的内容和布局。 风险预测工具的可用性和手册的内容将由医生（泌尿科医生（n=5）和医学肿瘤学家（n=5））和患者（n = 10）进行评价。 具体目标2a）： 培训泌尿科医生和肿瘤科医生使用咨询方案。在30分钟的培训课程中，将向医生介绍风险评估预测工具和医生手册的使用，并就适当的风险沟通原则进行教育。 目标2b） 与医生和MIBC幸存者评估咨询方案的可接受性和可行性。 符合NC条件的新诊断MIBC患者（N = 36），从两项研究中招募相同数量的患者 地点（西奈山和杜克大学），将参加咨询协议。 介入治疗前后的测量将评估患者的风险感知、患者与医生沟通的满意度以及决策制定变量。 本研究有可能通过将结构化风险沟通协议整合到患者医生咨询中来显著影响和改变临床实践。它是创新的，它是第一个将基于证据的风险预测工具与患者教育结合起来的联合收割机，用于MIBC患者的医生-患者咨询协议。

 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.