Assessing Quality of Life of Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Other: QoL assessment
- Registration Number
- NCT00041301
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 625
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description QoL in prostate cancer QoL assessment The study sample will be composed of a consecutive series of prostate cancer patients, stratified by stage of disease, local and locally advanced versus advanced (metastatic) disease, and undergoing active anti-tumor therapy. In order to increase sample homogeneity, and to facilitate evaluation of the responsiveness of the quality of life instruments to changes in patients' health status and symptoms experience over time, the subsample of patients with local or locally advanced disease will be restricted to those undergoing surgery (radical prostatectomy) or radiation therapy, and the subsample of metastatic disease patients will be limited to those receiving hormonal therapy.
- 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)
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
St. Elisabeth Ziekenhuis
🇳🇱Tilburg, Netherlands
Inselspital, Bern
🇷🇴Bucarest, Romania
Velindre Cancer Center at Velinde Hospital
🇬🇧Cardiff, Wales, United Kingdom
Virga Jesse Hospital
🇧🇪Hasselt, Belgium
Institute of Oncology - Bucarest
🇷🇴Bucarest, Romania
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Jeroen Bosch Ziekenhuis
🇳🇱's-Hertogenbosch, Netherlands
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
University Medical Center Rotterdam at Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Marmara University Hospital
🇹🇷Istanbul, Turkey
University of Wales College of Medicine
🇬🇧Cardiff, Wales, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Sir Charles Gairdner Hospital - Perth
🇦🇺Perth, Western Australia, Australia
Academisch Ziekenhuis der Vrije Universiteit Brussel
🇧🇪Brussels, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Rigshospitalet
🇩🇰Copenhagen, Denmark
Universitair Ziekenhuis Gent
🇧🇪Ghent, Belgium
Cazk Groeninghe - Campus Maria's Voorzienigheid
🇧🇪Kortrijk, Belgium
Spedali Civili
🇮🇹Brescia, Italy
Istituto Scientifico H. San Raffaele
🇮🇹Milano, Italy
Azienda Ospedaliera Maggiore Della Carita
🇮🇹Novara, Italy
Universita di Palermo
🇮🇹Palermo, Italy
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
🇮🇹Torino, Italy
Hopital Jean Bernard
🇫🇷Poitiers, France
Universitaetsklinikum Bonn
🇩🇪Bonn, Germany
Universitaets-Krankenhaus Eppendorf
🇩🇪Hamburg, Germany
Daniel Den Hoed Cancer Center at Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Norwegian Radium Hospital
🇳🇴Oslo, Norway
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
Dokuz Eylul University School of Medicine
🇹🇷Izmir, Turkey