NCT00041301

Assessing Quality of Life of Patients With Prostate Cancer

An International Field Study Of The Reliability And Validity Of The EORTC QLQ-C30 And A Disease-Specific Questionnaire Module (QLQ-PR25) For Assessing Quality Of Life Of Patients With Prostate Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 625 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate and long-term effects of the treatment on these patients. PURPOSE: Clinical trial to study the effectiveness of two questionnaires in assessing quality of life of patients who have prostate cancer.

Detailed description

OBJECTIVES: * Assess the scale structure, psychometric validity, and reliability of quality of life measurements using the EORTC QLQ-C30 and the prostate cancer-specific QLQ-PR25 questionnaires in patients with stage I-IV prostate cancer. OUTLINE: This is a multicenter study. Patients are stratified according to stage of disease (local or locally advanced disease vs metastatic disease). Patients complete EORTC QLQ-C30 and prostate cancer-specific QLQ-PR25 questionnaires before therapy and at 3 months after the start of therapy. Patients in stratum II also complete questionnaires at 6 months after the start of therapy. PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	QoL assessment	qol questionnaires

Timeline

• Start date: 2002-03-01
• Primary completion: 2004-12-01
• Completion: 2005-11-01
• First posted: 2003-01-27
• Last updated: 2012-08-27

Locations

33 sites across 11 countries: Australia, Belgium, Denmark, France, Germany, Italy, Netherlands, Norway, Romania, Turkey (Türkiye), United Kingdom