NCT07448545

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

February 26, 2026

Last Update Submit

March 3, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • UCLA Prostate Cancer Index

    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

    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

    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

Study Arms (1)

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

Other: Questionnaires

Interventions

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.

Prostate Cancer Patients

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThis study includes participants who self-identify as male, as prostate cancer is a disease affecting individuals with male reproductive anatomy.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists 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 in Türkiye.

You may qualify if:

  • Male patients
  • Diagnosis of prostate cancer

You may not qualify if:

  • Severe psychiatric or mental disorders that may impair the ability to complete the questionnaires properly
  • Presence of congenital deformities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokman Hekim University, Ankara, Ankara

Ankara, 6510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic NeoplasmsDisease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
115 Days
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant profesor

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 4, 2026

Study Start

January 20, 2022

Primary Completion

January 28, 2026

Study Completion

January 28, 2026

Last Updated

March 5, 2026

Record last verified: 2026-02

Locations