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Development, Validation, and Dissemination of an Integrated Risk Prediction Model and Decision Aid to Discern Aggressive Versus Indolent Prostate Cancer
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.
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.
Age
18 - No limit years
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
Start Date
July 19, 2018
Primary Completion Date
September 30, 2020
Completion Date
September 30, 2020
Last Updated
June 12, 2023
119
ACTUAL participants
Decision Support Intervention (DSI)
BEHAVIORAL
Lead Sponsor
University of California, San Francisco
Collaborators
NCT05691465
NCT06842498
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04550494