Decision Support Tools for Men With Prostate Cancer- Clinical & Lifestyle Model
Status: | Active, not recruiting |
---|---|
Conditions: | Prostate Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/17/2017 |
Start Date: | March 2015 |
End Date: | April 2020 |
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)).
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.
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.
Inclusion criteria are the following:
1. Men >18 years of age with newly diagnosed (within 3 month) low risk prostatecancer ,
who have not yet received cancer-directed therapy, Or Men who are at risk of prostate
cancer and coming to have a diagnostic biopsy, and diagnosed with low grade of
prostate cancer
2. Biopsy Gleason score < 3+3,
3. Has localized (clinical stage < T2N0M0) prostate cancer with a PSA <10ng/ml
4. Consent to research follow-up
Exclusion Criteria:
1. men with missing data on PSA, stage, Gleason, or extent of biopsy core involvement; no
baseline (diagnostic) biopsy or germline DNA sample for research; or no follow-up
pathology (from biopsy or RP) after diagnosis.
2. men unable to consent, prisoners, those with ECOG performance status >2, or
psychiatric illness/social situations that would limit compliance with study
requirements, or inability to read English or Spanish.
We found this trial at
2
sites
San Francisco, California 94143
Principal Investigator: Benjamin Breyer, MD, MAS
Phone: 415-353-7348
Click here to add this to my saved trials
1600 Divisadero Street
San Francisco, California 94115
San Francisco, California 94115
888.689.8273
Phone: 877-827-3222
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
Click here to add this to my saved trials