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 2 a): 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 2 b) 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.
Although there is convincing evidence based on multiple clinical trials that neoadjuvant chemotherapy prior to surgery confers a significant survival benefit among patients with muscle- invasive bladder cancer (MIBC), only a small proportion of patients receive such treatment. We are addressing this critical public health need by developing, refining and pilot-testing a risk prediction tool and educational brochure designed to inform patients about their treatment options. The goal is to enhance patient-physician shared decision making and to develop a standard risk communication protocol that can be applied and widely disseminated.
