Clinical trial · Interventional
Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer
Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men
NCT03103321CI-TRIAL-00085139completedPhase 3Results postedClinicalTrials.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)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PSA Level Five to Ten | — | UNRESOLVED | — |
| PSA Level Less Than Five | — | UNRESOLVED | — |
| PSA Level Ten to Fifty | — | UNRESOLVED | — |
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Internet-Based Intervention | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm A ("Knowing your Options", "Prostate Choice")
- description
- Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.
- interventionNames
- Other: Internet-Based Intervention
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Other: Survey Administration
- Other: Laboratory Biomarker Analysis
- type
- EXPERIMENTAL
- label
- Arm B ("Knowing your Options")
- description
- Patients receive "Knowing your Options" decision aid before their consultation visit.
- interventionNames
- Other: Internet-Based Intervention
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Other: Survey Administration
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDTilburt JC, Zahrieh D, Pacyna JE, Petereit DG, Kaur JS, Rapkin BD, Grubb RL 3rd, Chang GJ, Morris MJ, Kovac EZ, Babaian KN, Sloan JA, Basch EM, Peil ES, Dueck AC, Novotny PJ, Paskett ED, Buckner JC, Joyce DD, Montori VM, Frosch DL, Volk RJ, Kim SP. Decision aids for localized prostate cancer in diverse minority men: Primary outcome results from a multicenter cancer care delivery trial (Alliance A191402CD). Cancer. 2022 Mar 15;128(6):1242-1251. doi: 10.1002/cncr.34062. Epub 2021 Dec 10. PMID 34890060
- DERIVEDPacyna JE, Kim S, Yost K, Sedlacek H, Petereit D, Kaur J, Rapkin B, Grubb R, Paskett E, Chang GJ, Sloan J, Basch E, Major B, Novotny P, Taylor J, Buckner J, Parsons JK, Morris M, Tilburt JC. 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. BMC Cancer. 2018 Aug 6;18(1):788. doi: 10.1186/s12885-018-4672-3. PMID 30081846