N/A
Completed N=103
Decision Aids to Improve Knowledge in Patients With Prostate Cancer
Source: ClinicalTrials.gov NCT03182998 ↗Enrolled (actual)
103
Serious AEs
—
Results posted
Aug 2023
Primary outcomePrimary: Knowledge Assessed by Prostate Cancer Treatment Questionnaire — 0.69; 0.69; 0.64 score on a scale
Summary
This randomized phase III trial studies how well decision aids work in improving knowledge in patients with prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knowledge Assessed by Prostate Cancer Treatment Questionnaire |
0.69; 0.69; 0.64 | — |
| SECONDARY Decisional Quality as Measured by Decisional Regret Scale |
2; 3; 2; 3; 2; 5 | — |
| SECONDARY Quality of Life Assessed by Questionnaire |
79.7; 67.2; 85.8; 80.0; 90.0; 83.9 | — |
| SECONDARY Utilization as Determined by Chart Review |
1; 0; 1; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have prostate biopsy within 4 months prior to registration showing newly diagnosed prostate cancer, stage T1-3N0M0; in addition, patients must have: Gleason score 6-10
- Prostate-specific antigen (PSA) < 50 ng/mL
- Patients who have had a history of non-cutaneous malignancy in the previous 5 years are not eligible; exception: patients with history of non-melanoma skin cancer are eligible
- Scheduled prostate cancer consultation to be the first consultation after diagnosis (i.e. not a second-opinion or a consultation following previous discussions of treatment options)
- Patients may not be concurrently enrolled to another clinical trial for the treatment of cancer; co-enrollment to biospecimen studies is allowed
- Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
- Patients must be able to read and comprehend English; non-English-speaking patients may participate so long as an interpreter (e.g., family member, clinic staff, etc.) is present for consent, for the decision aid administration, and gathering of baseline and follow-up measures
Data sourced from ClinicalTrials.gov (NCT03182998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.