- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07448545
Turkish Version of the UCLA Prostate Cancer Index
Cross-Cultural Adaptation, Reliability and Validity of the UCLA Prostate Cancer Index in Turkish Patients
This study will evaluate the cross-cultural adaptation, validity, and reliability of the Turkish version of the UCLA Prostate Cancer Index in men diagnosed with prostate cancer. The original instrument will be translated and culturally adapted following standardized procedures. The psychometric properties of the Turkish version will be examined in patients attending routine follow-up visits at a urology clinic.
Internal consistency will be assessed using Cronbach's alpha coefficients, and test-retest reliability will be evaluated using intraclass correlation coefficients (ICC) in a subset of participants. Measurement error will be determined by calculating the standard error of measurement (SEM) and the smallest real difference at the 95% confidence level (SRD95). Construct validity will be examined through exploratory factor analysis, and convergent validity will be assessed by testing predefined hypotheses regarding correlations between the UCLA Prostate Cancer Index and established quality-of-life instruments (SF-36 and EORTC QLQ-PR25).
The findings are expected to provide a reliable and valid prostate cancer-specific quality-of-life assessment tool for use in Turkish-speaking populations.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey (Türkiye), 6510
- Lokman Hekim University, Ankara, Ankara
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male patients
- Diagnosis of prostate cancer
Exclusion Criteria:
- Severe psychiatric or mental disorders that may impair the ability to complete the questionnaires properly
- Presence of congenital deformities
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Prostate Cancer Patients
This cohort will consist of men aged 45 years and older who have been diagnosed with prostate cancer and are attending routine follow-up visits at a urology outpatient clinic
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Participants will complete the Turkish version of the UCLA Prostate Cancer Index along with the SF-36 and EORTC QLQ-PR25 questionnaires.
No intervention will be applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
UCLA Prostate Cancer Index
Time Frame: 1 hour
|
The University of California, Los Angeles (UCLA) Prostate Cancer Index was developed in English in 1998 by Litwin et al. and has been psychometrically validated in prostate cancer populations.
It evaluates urinary, sexual, and bowel function and the associated symptom-related bother in men treated for prostate cancer
|
1 hour
|
|
EORTC QLQ-PR25
Time Frame: 1 hour
|
The EORTC QLQ-PR25 is a prostate cancer-specific module consisting of 25 items and comprising six symptom subdomains: urinary symptoms, incontinence aid, bowel symptoms, hormonal treatment-related symptoms, sexual activity, and sexual functioning
|
1 hour
|
|
SF-36
Time Frame: 1 hour
|
It is a widely used 36-item questionnaire that evaluates health-related QoL across eight domains, including physical functioning, role limitations due to physical and emotional problems, mental health, vitality, social functioning, bodily pain, and general health
|
1 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Pathological Conditions, Signs and Symptoms
- Prostatic Neoplasms
- Disease
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- 2021/14-42
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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