Pioneering Advances in Care and Education (PACE)
NCT03397160 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119
Last updated 2023-06-12
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.
Conditions
- Decision Support Systems, Clinical
- Prostate Cancer
Interventions
- 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).
Sponsors & Collaborators
-
CentraCare Adult & Pediatric Urology
collaborator UNKNOWN -
Lancaster Urology
collaborator UNKNOWN -
San Francisco Veterans Affairs Medical Center
collaborator FED -
Palo Alto Medical Foundation
collaborator OTHER -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Peter R Carroll, MD, MPH · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-19
- Primary Completion
- 2020-09-30
- Completion
- 2020-09-30
Countries
- United States
Study Locations
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