NCT03397160

Pioneering Advances in Care and Education (PACE)

Development, Validation, and Dissemination of an Integrated Risk Prediction Model and Decision Aid to Discern Aggressive Versus Indolent Prostate Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Decision Support Systems, Clinical
• Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Decision Support Intervention (DSI)	A question list (QL) that includes areas of patient concern are created by the health coach for use by the patient and the urologist at their first consultation visit where they discuss the extent of their cancer and consider treatment options. The coach uses the Prostate Cancer SCOPED model to complete a "Prostate Cancer SCOPED Model Form". The SCOPED model uses concepts such as the situation, choices (treatment), objectives (personal goals and priorities), people (involved in supporting a treatment decision), evaluation and decisions (clarifying which choice is best and next steps).

Timeline

• Start date: 2018-07-19
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2018-01-11
• Last updated: 2023-06-12

Locations

4 sites across 1 country: United States