Clinical trial NCT06435871: Developing Inclusive Support and Intervention for Spanish-speaking Latiné Prostate Cancer Survivors
Official title: Developing Inclusive Support and Intervention for Spanish-speaking Latiné Prostate Cancer Survivors: Understanding Cultural Nuances in Survivorship Decision Making
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Latinos
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 288
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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)

Primary outcomes:
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
measure: Bowel health-related QoL as measured using the validated EPIC-26 questionnaire
timeFrame: During group interview (minimum of three 90-minute sessions) post radical prostatectomy
measure: Sexual health-related QoL as measured using the validated EPIC-26 questionnaire
timeFrame: During group interview (minimum of three 90-minute sessions) post radical prostatectomy
measure: Hormonal health-related QoL as measured using the validated EPIC-26 questionnaire
timeFrame: During group interview (minimum of three 90-minute sessions) post radical prostatectomy
measure: QoL as measured using the combined score of EPIC-26 questionnaire
timeFrame: During group interview (minimum of three 90-minute sessions) post radical prostatectomy
Secondary outcomes:
measure: Decisional conflict as assesed by decisional conflict scores
timeFrame: During group interview (minimum of three 90-minute sessions) post radical prostatectomy
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center
name: Christopher Weight, MD
role: PRINCIPAL_INVESTIGATOR
References: