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Support and Intervention for Latiné Prostate Cancer Survivors

N/A
Waitlist Available
Led By Christopher Weight, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Localized Prostate Cancer
Underwent radical prostatectomy by their urological surgeon
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during group interview (minimum of three 90-minute sessions) post radical prostatectomy
Awards & highlights

Summary

This trial aims to study the challenges faced by Latiné men with prostate cancer, including low health literacy and cultural factors. The study will involve 288 participants from different medical facilities, with a focus on

Who is the study for?
This trial is for Spanish-speaking Latiné men who have survived prostate cancer. It aims to understand their unique challenges in post-treatment issues and decision-making, considering cultural and language barriers.
What is being tested?
The study tests the effectiveness of tailored resources like educational videos in Spanish. It involves surveys (Expanded Prostate Cancer Index Composite) and scales (Decision Regret Scale) to measure outcomes.
What are the potential side effects?
Since this trial focuses on surveys and educational materials rather than medical treatments, there are no direct physical side effects associated with participating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with prostate cancer that has not spread.
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I had surgery to remove my prostate gland.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is getting worse and I need treatments like hormone therapy, chemotherapy, or immunotherapy.
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I had treatments like cryotherapy or HIFU for my prostate cancer.
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My primary language is neither English nor Spanish.
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My first treatment for cancer was radiation or brachytherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during group interview (minimum of three 90-minute sessions) post radical prostatectomy
This trial's timeline: 3 weeks for screening, Varies for treatment, and during group interview (minimum of three 90-minute sessions) post radical prostatectomy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bowel health-related QoL as measured using the validated EPIC-26 questionnaire
Hormonal health-related QoL as measured using the validated EPIC-26 questionnaire
QoL as measured using the combined score of EPIC-26 questionnaire
+2 more
Secondary outcome measures
Decisional conflict as assesed by decisional conflict scores

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prostate cancer treatment outcomesExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
459 Previous Clinical Trials
32,000 Total Patients Enrolled
32 Trials studying Prostate Cancer
3,113 Patients Enrolled for Prostate Cancer
Christopher Weight, MDPrincipal InvestigatorCleveland Clinic Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Prostate Cancer
30 Patients Enrolled for Prostate Cancer
~192 spots leftby Jul 2025
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