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临床试验/NCT07448545
NCT07448545
已完成
不适用

Cross-Cultural Adaptation, Reliability and Validity of the UCLA Prostate Cancer Index in Turkish Patients

Lokman Hekim University1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2022年1月20日最近更新:
干预措施Questionnaires

概览

阶段
不适用
状态
已完成
发起方
Lokman Hekim University
入组人数
115
试验地点
1
主要终点
UCLA Prostate Cancer Index

概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

性别
Male
接受健康志愿者

入选标准

  • Male patients
  • Diagnosis of prostate cancer

排除标准

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

研究组 & 干预措施

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

干预措施: Questionnaires (Other)

结局指标

主要结局

UCLA Prostate Cancer Index

时间窗: 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

EORTC QLQ-PR25

时间窗: 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

SF-36

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Lokman Hekim University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Demet Öztürk

Assistant profesor

Lokman Hekim University

研究点 (1)

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