Developing Inclusive Support and Intervention for Spanish-speaking Latiné Prostate Cancer Survivors

NCT06435871 | Active Not Recruiting DMC

• 1 other identifier: CASE9824
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

Latinos

Outcome Measures

Primary Outcomes (5)

• Urinary health-related QoL as measured using the validated EPIC-26 questionnaire

  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.

  During group interview (minimum of three 90-minute sessions) post radical prostatectomy

• Bowel health-related QoL as measured using the validated EPIC-26 questionnaire

  The EPIC questionnaire evaluates bowel health-related quality of life domains specific to prostate cancer patients: It is a 13-question survey, where questions 6-7 are focused on the bowel 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.

  During group interview (minimum of three 90-minute sessions) post radical prostatectomy

• Sexual health-related QoL as measured using the validated EPIC-26 questionnaire

  The EPIC questionnaire evaluates sexual health-related quality of life domains specific to prostate cancer patients: It is a 13-question survey, where questions 8-12 are focused on the sexual 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.

  During group interview (minimum of three 90-minute sessions) post radical prostatectomy

• Hormonal health-related QoL as measured using the validated EPIC-26 questionnaire

  The EPIC questionnaire evaluates hormonal health-related quality of life domains specific to prostate cancer patients: It is a 13-question survey, where question 13 is focused on the hormonal 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.

  During group interview (minimum of three 90-minute sessions) post radical prostatectomy

• QoL as measured using the combined score of EPIC-26 questionnaire

  The EPIC questionnaire evaluates health-related quality of life domains specific to prostate cancer patients: It is a 13-question survey. 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.

  During group interview (minimum of three 90-minute sessions) post radical prostatectomy

Secondary Outcomes (1)

• Decisional conflict as assesed by decisional conflict scores

  During group interview (minimum of three 90-minute sessions) post radical prostatectomy

Study Arms (1)

Prostate cancer treatment outcomes

EXPERIMENTAL

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.

Behavioral: Expanded Prostate Cancer Index Composite and Decision Regret Scale

Interventions

Expanded Prostate Cancer Index Composite and Decision Regret Scale BEHAVIORAL

This comprehensive instrument measures urinary, sexual, and bowel symptoms in men treated for prostate cancer. It can provide a detailed view of the patient's quality of life post-treatment.

Prostate cancer treatment outcomes

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Christopher Weight, MD

  Cleveland Clinic Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 30, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available for the duration of the study \~ 2 years.
• Access Criteria: Each institution will collect their own patient data into their own RedCap. No PHI data will be shared amongst the institutions - only de-identified data will be shared from CCF to UCSD via REDCAP and included in analyses which will be performed by specialist data analysts at UCSD and by investigators listed on this IRB. Access to the data will be limited to authorized personnel only, who will be required to maintain strict confidentiality and adhere to data protection regulations.

Locations

US (1)