Clinical trial · Interventional
Developing Inclusive Support and Intervention for Spanish-speaking Latiné Prostate Cancer Survivors
Developing Inclusive Support and Intervention for Spanish-speaking Latiné Prostate Cancer Survivors: Understanding Cultural Nuances in Survivorship Decision Making
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
Prostate cancer is a significant concern for Latiné men, with over 17,000 new cases annually. Decision-making for treatment is complex, especially due to barriers like low health literacy and cultural factors. Research on survivorship and post-treatment issues like erectile dysfunction is lacking. To improve care, a study will engage 288 participants across various medical facilities, including 100 at Cleveland Clinic. Thirty subjects will participate in focus groups representing Spanish-speaking Latiné, bilingual Latiné, and English-speaking non-Latiné individuals to understand their perspectives and enhance communication. This aims to develop tailored resources, like Spanish-language educational videos, addressing language and cultural needs for informed decision-making.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Expanded Prostate Cancer Index Composite and Decision Regret Scale | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prostate cancer treatment outcomes
- description
- The study population will be divided into three cohorts: * Spanish-speaking preferred Latiné, * English-speaking preferred Latiné, * English-speaking non-Latiné patients. Domain assessments between groups will be made using ANOVA with pairwise comparisons.
- interventionNames
- Behavioral: Expanded Prostate Cancer Index Composite and Decision Regret Scale
Primary outcomes (5)
- measure
- Urinary health-related QoL as measured using the validated EPIC-26 questionnaire
- timeFrame
- During group interview (minimum of three 90-minute sessions) post radical prostatectomy
- description
- The EPIC questionnaire evaluates urinary health-related quality of life domains specific to prostate cancer patients: It is a 13-question survey, where 1-5 are focused on the urinary health. Responses are given on a Likert scale, ranging from "very poor" to "very good" or "no problem" to "big problem," depending on the question.One-way ANOVA test is used for comparison of EPIC domains between the three cohorts.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults \>18 years * Diagnosis of Localized Prostate Cancer * Underwent radical prostatectomy by their urological surgeon * Subjects must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patient whose primary language is not English or Spanish * Patients who had brachytherapy and/or radiation treatment as their initial treatment * Patients with disease progression at time study recruitment who are requiring other treatments (ADT, chemotherapy, immunotherapy) * Patients who underwent current non-standard prior treatment options for localized prostate cancer including cryotherapy and high intensity focused ultrasound (HIFU)
References
Publications (0)
Data not yet available