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

Prostate Cancer Clinical Trial

Official title:

Developing Inclusive Support and Intervention for Spanish-speaking Latiné Prostate Cancer Survivors: Understanding Cultural Nuances in Survivorship Decision Making

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06435871
• Other study ID #: CASE9824
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: Case Comprehensive Cancer Center
• Contact: Christophar Weight, MD
• Phone: (216) 317- 8138
• Email: weight[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Prostate cancer is the most common non-skin cancer among Latiné men, with over 17,000 new cases yearly. While most men live with the disease rather than die from it, ensuring quality of life is crucial in treatment decisions. Latiné men face unique decision-making challenges due to low health literacy, barriers to healthcare access, and cultural differences in treatment understanding and communication. Decision aids that consider patient values and cultural nuances like familismo are essential for effective shared decision-making.

Despite the significance of racial and ethnic disparities in prostate cancer outcomes, research has been limited, especially among Latiné populations. The CEASAR study highlighted the need for more inclusive research, showing no significant outcome differences across racial groups but underrepresenting Latiné men. The Urology Care Foundation has provided Spanish-language resources, yet there's a gap in materials discussing treatment choices in the context of sexual, bowel and urinary health post-treatment.

This gap underlines the necessity for research focused on the Latiné community's perspectives on prostate cancer survivorship, particularly concerning erectile dysfunction, bowel function and urinary function. This study aims to fill this void through focus groups to better understand Latiné men's views and enhance patient education and shared decision-making. A Spanish-language educational video informed by these insights will address the critical need for culturally and linguistically appropriate resources, bridging the information gap for Spanish-speaking survivors

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 288
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Expanded Prostate Cancer Index Composite and Decision Regret Scale
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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Decisional conflict as assesed by decisional conflict scores	The DRS is a 5-item Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree), designed to evaluate distress or remorse following a healthcare decision. Comparison of decisional conflict scores between the study groups using one-way ANOVA testing.	During group interview (minimum of three 90-minute sessions) post radical prostatectomy