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Brief Title: Pioneering Advances in Care and Education (PACE)
Official Title: Development, Validation, and Dissemination of an Integrated Risk Prediction Model and Decision Aid to Discern Aggressive Versus Indolent Prostate Cancer
Study ID: NCT03397160
Brief Summary: This clinical trial evaluates the use of novel decision support educational materials and services using health coaches. The study includes men newly diagnosed with low-risk prostate cancer. A 160 men will be recruited. Half of the men will receive a call from a health coach before their initial consultation visit with their urologist to review their treatment concerns and questions. The other half will receive usual care provided by the urologist, such as educational materials and services provided by the urologist.
Detailed Description: A critical public health need exists for improved prognostic tools to distinguish aggressive from slow growing prostate cancer at diagnosis, and for better support systems to guide patients in decision-making regarding management options. Decision support interventions that are tailored to specific clinical conditions are known to have increased patient self-efficacy, knowledge, question-asking, and satisfaction; and decreased decisional conflict, regret, anxiety, and distress. To reduce the risk of over-treatment, our team has developed individual risk prediction models that we have now integrated into our decision support intervention (DSI). Delivering such decision support intervention should increase patient knowledge and question-asking by the patient to their doctor. The decision support intervention can be delivered by telephone and or the Internet.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Palo Alto Medical Foundation, Palo Alto, California, United States
University of California San Francisco, San Francisco, California, United States
CentraCare Clinic Adult & Pediatric Urology, Sartell, Minnesota, United States
Lancaster Urology, Lancaster, Pennsylvania, United States
Name: Peter R Carroll, MD, MPH
Affiliation: University of California, San Francisco
Role: PRINCIPAL_INVESTIGATOR