Assessing Quality of Life of Patients With Prostate Cancer

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00041301
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief 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.

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2002-07-08
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-12
• Study Completion: 2005-11
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-24
• Last Update Posted: 2012-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 625

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
psychometric validity of the PR25 module	before start of treatment, three months after the start of primary treatment and six months after the start of primary treatment.	Quality of life scores will be evaluated for psychometric validity by: * Scale structure using multi-trait scaling analysis; * Reliability using tests of internal consistency; * Test-retest reliability; * Validity using inter-scale correlations and known group comparisons; * Sensitivity to change using two measurements of Quality of Life and ANOVA to look for the significance of changes in quality of life scores as a function of observed changes in clinical status over time.

Secondary Outcome Measures

Name	Time	Method
debriefing questionnaire information	at baseline	Patients will be asked to complete a short debriefing questionnaire covering questions about the time taken to complete the EORTC QLQ-C30 and QLQ-PR25; the need for help in completing the questionnaires and querying whether any of the questionnaire items were confusing; difficult to answer or upsetting.

Trial Locations

Locations (33)

Sir Charles Gairdner Hospital - Perth; 🇦🇺 Perth, Western Australia, Australia

Academisch Ziekenhuis der Vrije Universiteit Brussel; 🇧🇪 Brussels, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Ghent, Belgium

Virga Jesse Hospital; 🇧🇪 Hasselt, Belgium

Cazk Groeninghe - Campus Maria's Voorzienigheid; 🇧🇪 Kortrijk, Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Hopital Jean Bernard; 🇫🇷 Poitiers, France

Universitaetsklinikum Bonn; 🇩🇪 Bonn, Germany

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