Clinical trial · Interventional
Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer
Development and Testing of a Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study Team did not respond to requests for continuing review approval.
Summary
Brief summary (as posted)
A pilot study testing the effect of an in-visit English and Spanish language decision aid for Hispanic-Latino men using best practices of cultural tailoring to be used in urology practice. Subjects will be followed for approximately 1 year during standard care in-clinic office visits. Study results and subject surveys will be analyzed to determine clinical utility of the tool.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| baseline survey | Behavioral | — | UNRESOLVED |
| Decision Aid Tool | Behavioral | — | UNRESOLVED |
| follow-up surveys | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Decision Aid
- description
- Subjects will be asked to complete baseline surveys. Once the surveys are completed, subjects will review the Decision Aid tool with a study team member. Once the subjects have gone through the tool, study team members will answer any additional questions he may have regarding the tool. The subjects will then discuss with the investigator various cancer management options, quality of life implications, and any questions the subjects may have regarding cancer management options. Subjects that are ready may make a cancer management decision at this time, or choose to wait until their next scheduled visit. Subjects will be followed at subsequent urology clinic visits for up to 6 months. Subjects will complete follow-up surveys at the 3, 6, 9 and 12 month visits.
- interventionNames
- Behavioral: Decision Aid Tool
- Behavioral: baseline survey
- Behavioral: follow-up surveys
Primary outcomes (3)
- measure
- Decision Quality of cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
- timeFrame
- Up to 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects utilize English or Spanish as their primary spoken or written language and identify with a Latino ethnicity and/or culture * Men with a new histologic diagnosis of localized prostate cancer * PSA level of 0.1 - 50 ng/dl * Gleason score of 6 - 10 * Cancer stage: T1 - 4N x M0 Exclusion Criteria: * Metastatic disease, including lymph nodes or distant metastasis * PSA \> 50 ng/dl * Individuals with a medical condition that necessitates a specific prostate cancer treatment plan * Individuals that are unwilling or unable to attend study visits or are planning to move out of a study site coverage area during the subject's anticipated participation in the study
References
Publications (0)
Data not yet available