Clinical trial · Interventional
Decision Support Tools for Men With Prostate Cancer- Clinical & Lifestyle Model
Development, Validation, and Dissemination of an Integrated Risk Prediction Model and Decision Aid to Discern Aggressive vs Indolent Prostate Cancer (Aim 2A)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Personalized risk model+website+coaching intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Personalized risk model+website+phone coaching
- interventionNames
- Behavioral: Personalized risk model+website+coaching intervention
Primary outcomes (1)
- measure
- Decision Quality measured using the Decision Quality Index
- timeFrame
- 12 months
- description
- measured using the Decision Quality Index
Secondary outcomes (2)
- measure
- Prostate Cancer Specific Anxiety measured using MAXPC survey
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available