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Grant Details

Grant Number: 5R21CA176551-02 Interpret this number
Primary Investigator: Diefenbach, Michael
Organization: Feinstein Institute For Medical Research
Project Title: Novel Approach to Facilitate Decisions in Patients W Muscle Invasive Bladder CA
Fiscal Year: 2016


¿ 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.


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