Pioneering Advances in Care and Education (PACE)
Completed · Not applicable
Conditions studied: Decision Support Systems, Clinical, Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT03397160
- Run by
- University of California, San Francisco
- People needed
- 119
- Starts
- 2018-07-19
- Expected to finish
- 2020-09-30
- Last updated by the study team
- 2023-06-12
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Male >=18 years of age and newly diagnosed prostate cancer (PCa) (within 3-months).
- Documentation of a low-risk PCa diagnosis as evidenced by clinical features of the following criteria:
- PSA test at diagnosis <=15 ng/ml
- Localized PCa (cT1/T2,N0,M0)
- Biopsy Gleason grade 2-6 OR (or 3+4 AND <=33% cores are positive for adenocarcinoma)
- **A minimum of 10 diagnostic cores taken by a systematic directed approach. Sampling may be obtained by target transrectal ultrasound (TRUS) or MRI imaging.
- No treatment yet
- No previous radiation or simultaneous use of androgen deprivation
- Prior use of 5-alpha reductase inhibitor is allowed if they have been stopped for 6 or more months and biopsy performed when patient was not taking the drug
- English language proficient and ability to provide informed consent
- Managing urologist considers them a candidate for active surveillance
- Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study, including the ability to read and speak English.
You may not qualify if…
- Participants will be ineligible if they:
- have pursued any active therapy for prostate cancer will be excluded;
- are unable to read/speak English; or
- if their managing urologist does NOT deem them as a candidate for active surveillance.
Where it is running
- 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
Full record on ClinicalTrials.gov
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