Prostate Cancer Clinical Trial
Official title:
Development, Validation, and Dissemination of an Integrated Risk Prediction Model and Decision Aid to Discern Aggressive vs Indolent Prostate Cancer (Aim 2A)
A UCSF PI-initiated study with a primary goal to improve decision quality, anxiety, and
uncertainty, thereby increasing appropriate uptake of active surveillance and reducing
over-treatment of low-risk prostate cancer.
This study involves: completion of questionnaires through the secure website; consultation by
a health coach to aid men with prostate cancer in making informed treatment decision
(personalized coaching session(s)).
A UCSF PI-initiated study which includes comprehensive decision support intervention that may
incorporate clinical, lifestyle, tumor genomic, and germline gene variant data.
The web and coaching intervention will: 1) summarize key prognostic data elements, 2)
communicate relative and absolute risks of upgrading/upstaging based on each of these
elements, individually and in aggregate, and 3) provide tailored educational information for
informed decision making on treatment options. A key aspect of the intervention will be
provision of tiered coaching to the men prior to their physician visits to help them enter
information accurately into the system, understand the results of the prediction model,
document their questions for their physicians, and prepare them to make better-informed
treatment decisions. UCSF research team will develop the decision support intervention in
phases, initially using only clinical variables, BMI (body mass index), and smoking data;and
then extend it to include information from genomic and genetic inputs, as validation work
progresses. Variables will be retained based on statistical evaluation of the predictive
values.
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