Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
Peter R Carroll, MD, MPH
Photo of Peter R Carroll
Peter R Carroll

Description

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.

Official Title

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

Details

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.

Keywords

Decision Support Systems, Clinical Prostate Cancer Transformative Impact Award Early stage Active surveillance Decision aid Coaching session Personalized University of California, San Francisco (UCSF) Validation Prostatic Neoplasms Decision Support Intervention (DSI)

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • University of California San Francisco
    San Francisco California 94158 United States
  • Palo Alto Medical Foundation
    Palo Alto California 94301 United States

Lead Scientist at UCSF

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
UCSF Department of Urology - Study Proposals and Working with Data
ID
NCT03397160
Study Type
Interventional
Last Updated