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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06435871
Enrollment
55
Registered
2024-05-30
Start date
2024-10-08
Completion date
2026-07-01
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Latinos

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.

Detailed 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

Interventions

BEHAVIORALExpanded 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.

Sponsors

Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Urinary health-related QoL as measured using the validated EPIC-26 questionnaireDuring group interview (minimum of three 90-minute sessions) post radical prostatectomyThe 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.
Bowel health-related QoL as measured using the validated EPIC-26 questionnaireDuring group interview (minimum of three 90-minute sessions) post radical prostatectomyThe 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.
Sexual health-related QoL as measured using the validated EPIC-26 questionnaireDuring group interview (minimum of three 90-minute sessions) post radical prostatectomyThe 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.
Hormonal health-related QoL as measured using the validated EPIC-26 questionnaireDuring group interview (minimum of three 90-minute sessions) post radical prostatectomyThe 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.
QoL as measured using the combined score of EPIC-26 questionnaireDuring group interview (minimum of three 90-minute sessions) post radical prostatectomyThe 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.

Secondary

MeasureTime frameDescription
Decisional conflict as assesed by decisional conflict scoresDuring group interview (minimum of three 90-minute sessions) post radical prostatectomyThe 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORChristopher Weight, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026