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Trial Title:
Developing Inclusive Support and Intervention for Spanish-speaking Latiné Prostate Cancer Survivors
NCT ID:
NCT06435871
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Latinos
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Expanded Prostate Cancer Index Composite and Decision Regret Scale
Description:
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.
Arm group label:
Prostate cancer treatment outcomes
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
Criteria for eligibility:
Criteria:
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)
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cleveland Clinic Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christopher Weight, MD
Email:
weight@ccf.org
Start date:
October 8, 2024
Completion date:
July 1, 2026
Lead sponsor:
Agency:
Case Comprehensive Cancer Center
Agency class:
Other
Source:
Case Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06435871
