Prostate cancer is the second most frequent cause of cancer mortality for men. Definitive, comparative treatment outcome data for localized prostate cancer are lacking. Men must choose among treatment options that may offer similar mortality benefits but differ in the likelihood and patterns of significant side effects that typically affect their lives for many years. The overall goal of the proposed research is to reduce decisional conflict (the confusion and anxiety many patients experience during and following decisions) associated with delayed decisions that may result in excess morbidity and other costs to the patient, family, and health care system and improve patient quality of life following prostate cancer diagnosis and treatment by increasing the likelihood that they feel well-informed about all their treatment options, clear about the impact of the treatment on their relevant personal values, and have adequate support in making their choice and undergoing treatment. We conducted a needs assessment with men treated for localized prostate cancer and based on the findings, developed a nurse-delivered, treatment decision making support intervention and conducted a limited pretest of that intervention. The intervention utilizes a Patient Notebook with a nurse navigator working with the patient and the patient's physicians to facilitate treatment decision making and (if active treatment is selected), the treatment and recovery process. In a future, large-scale randomized control trial (RCT) with 18-24 months follow-up, we plan to determine the intervention's effectiveness in: 1) reducing decisional conflict, 2) decreasing the interval between diagnosis and treatment decision (active or watchful waiting), 3) improving adjustment to treatment outcomes, 4) increasing satisfaction with care and with the treatment decision process, 5) reducing overall health care resource utilization during the decision process, and 6) improving quality of life. To better plan and justify this future study, we propose to conduct a 2-year pilot test with a historical control. We will compare outcomes at 9 months post-diagnosis between men diagnosed in a large multi- specialty health care system during an 11-month period in which the intervention was not available (N=90) with outcomes for men diagnosed in the subsequent 11 months who were exposed to the intervention (N=90). Outcomes include: decisional conflict, the interval between diagnosis and treatment decision, prostate cancer-specific quality of life and related anxiety, general health-related quality of life, and health resource utilization. We will extract relevant clinical and health resource use data from participants'electronic health records for the 9 months pre- and post-diagnosis, using this information to adjust for group differences in baseline medical and demographic characteristics. We will monitor the intervention and research process (recruitment rates, intervention fidelity and exposure) to guide planning of the RCT.
Treatment decisions for prostate cancer, the second most frequent cause of cancer deaths for men, should take into account the man's personal values and preferences, since treatment options may offer similar mortality benefits but have very different, significant, long-term side effects. We propose to pilot test an education and decision support program to find out if it facilitates more informed and satisfying choices, leading to reduced uncertainty, anxiety, and regrets about treatment decisions and improved patient quality of life.
