Clinical trial NCT02451345: Decision Support Tools for Men With Prostate Cancer- Clinical & Lifestyle Model
Official title: Development, Validation, and Dissemination of an Integrated Risk Prediction Model and Decision Aid to Discern Aggressive vs Indolent Prostate Cancer (Aim 2A)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Tranformative Impact Award
Early stage
Active Surveillance
Decision aid
Coaching session
Personalized
UCSF
validation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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)).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Decision Quality measured using the Decision Quality Index
timeFrame: 12 months
Secondary outcomes:
measure: Prostate Cancer Specific Anxiety measured using MAXPC survey
timeFrame: 12 months
measure: Decision Self- Efficacy measured using Decision Self-Efficacy survey
timeFrame: 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco (SFGH)
state: California
Study officials:
affiliation: University of California, San Francisco
name: Peter Carroll, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: