Pioneering Advances in Care and Education (PACE)
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/27/2018 |
| Start Date: | October 10, 2017 |
| End Date: | September 30, 2019 |
| Contact: | Jeffrey Belkora, PhD |
| Email: | Jeff.Belkora@ucsf.edu |
| Phone: | 415-964-0401 |
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.
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.
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.
Inclusion Criteria:
- Male ≥18 years of age and newly diagnosed PCa (within 3-months).
- Documentation of a low-risk PCa diagnosis as evidenced by clinical features of the
following criteria:
1. Prostate-specific antigen (PSA) test at diagnosis ≤15 ng/ml
2. Localized prostate cancer (PCa) (clinical tumor staging 1/2,N0,M0)
d. No treatment yet
- English language proficient and ability to provide informed consent
- Managing urologist considers them a candidate for active surveillance
Exclusion Criteria:
- Participants will be ineligible if they: 1) have pursued any active therapy for
prostate cancer will be excluded; 2) are unable to read/speak English; or 3) if their
managing urologist does NOT deem them as a candidate for active surveillance.
We found this trial at
4
sites
Lancaster, Pennsylvania 17604
Principal Investigator: Paul Sieber, MD
Phone: 717-431-2285
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San Francisco, California 94121
Principal Investigator: Matthew R Cooperberg, MD, MPH
Phone: 800-526-4433
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San Francisco, California 94143
Principal Investigator: Peter R Carroll, MD, MPH
Phone: 415-353-7348
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Sartell, Minnesota 56377
Principal Investigator: Lori A Pinke, MD
Phone: 320-229-4547
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