Clinical trial · Interventional
Devel. and Eval. of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer
CDC SIP: Rochester Prevention Research Center: Development and Evaluation of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer
NCT02342626CI-TRIAL-00031099completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer.
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 |
|---|---|---|---|
| Adenocarcinoma of Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dashboard | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- No use of the decision aid dashboard before, during or after the treatment decision time period.
- type
- EXPERIMENTAL
- label
- Dashboard
- description
- Use of the decision aid dashboard before, during and after the treatment decision time period.
- interventionNames
- Behavioral: Dashboard
Primary outcomes (1)
- measure
- Increase in KUJ score through education
- timeFrame
- 2 years
- description
- The use of the dashboard will increase patient knowledge and understanding of treatment options as measured using KUJ questionnaire.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 40 to 85 years * Sex: male * Race/ethnicity: no restrictions * Diagnosis: Patients will be eligible for the study if they have not yet decided on a management plan and present with either: * localized, low grade prostate cancer, defined as Gleason score ≤ 6, T1-T2a stage cancers, and PSA values \< 10 ng/ml, OR * Intermediate risk prostate cancer, defined as Gleason score = 7, T2b-T2c stage cancers (these tumors involve more of the prostate but do not extend beyond the prostatic capsule), or PSA 10-20 ng/ml * Willing to participate and able to give informed consent * Able to adequately see the study intervention which is an interactive decision dashboard \& complete study-related questionnaires * Able to understand English language adequately to use the decision dashboard and complete study-related questionnaires Exclusion Criteria: * Unable to complete study-related tasks due to cognitive deficits or English non-fluency * Unwilling to participate. * Deemed clinically unsuitable for active surveillance as a prostate cancer management option
References
Publications (0)
Data not yet available
No reference posted for this study.