Phase 3
Completed N=158
Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer
Stage II Prostate Cancer · Stage IIA Prostate Cancer · Stage IIB Prostate Cancer · Stage III Prostate Cancer
Source: ClinicalTrials.gov NCT03103321 ↗
Enrolled (actual)
158
Serious AEs
—
Results posted
Jan 2022
Primary outcomePrimary: Knowledge Assessed by Prostate Cancer Treatment Questionnaire — 0.69; 0.65; 0.58; 0.56 percentage of items correct
◆ Published Evidence
Emerging
18citations · ~5 / year
Decision aids for localized prostate cancer in diverse minority men: Primary outcome results from a multicenter cancer care delivery trial (Alliance A191402CD).
Summary
This randomized phase III trial studies how well decision aids work in improving knowledge in patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.
Linked Publications (2)
-
Decision aids for localized prostate cancer in diverse minority men: Primary outcome results from a multicenter cancer care delivery trial (Alliance A191402CD).
-
The comparative effectiveness of decision aids in diverse populations with early stage prostate cancer: a study protocol for a cluster-randomized controlled trial in the NCI Community Oncology Research Program (NCORP), Alliance A191402CD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knowledge Assessed by Prostate Cancer Treatment Questionnaire |
0.69; 0.65; 0.58; 0.56 | — |
| SECONDARY Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret |
13; 15; 25; 30; 11; 23 | — |
| SECONDARY Clinical Time Required |
27; 38; 52.5; 39.5 | — |
| SECONDARY Quality of Life Assessed by Questionnaire |
90.63; 93.75; 90.63; 87.5; 96.88; 85.5 | — |
| SECONDARY Utilization as Determined by Chart Review |
4; 9; 15; 16; 6; 17 | — |
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 (NCT03103321) and the linked publication. 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.