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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00041301 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Procedure: quality-of-life assessment |
| Study Type: | Observational |
| Official Title: | 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 |
| Study Start Date: | March 2002 |
OBJECTIVES:
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.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Stratum I:
Clinically localized primary prostate cancer
Local or locally advanced primary prostate cancer
Stratum II:
Metastatic prostate cancer
Plan to receive hormonal treatment
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| Australia, Western Australia | |
| Sir Charles Gairdner Hospital - Perth | |
| Perth, Western Australia, Australia, 6009 | |
| Belgium | |
| Academisch Ziekenhuis der Vrije Universiteit Brussel | |
| Brussels, Belgium, 1090 | |
| Cazk Groeninghe - Campus Maria's Voorzienigheid | |
| Kortrijk, Belgium, B-8500 | |
| Cliniques Universitaires Saint-Luc | |
| Brussels, Belgium, 1200 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Universitair Ziekenhuis Gent | |
| Ghent, Belgium, B-9000 | |
| Virga Jesse Hospital | |
| Hasselt, Belgium, 3500 | |
| Denmark | |
| Rigshospitalet | |
| Copenhagen, Denmark, 2100 | |
| France | |
| Hopital Jean Bernard | |
| Poitiers, France, 86021 | |
| Germany | |
| Universitaetsklinikum Bonn | |
| Bonn, Germany, D-53105 | |
| Universitaets-Krankenhaus Eppendorf | |
| Hamburg, Germany, D-20246 | |
| Italy | |
| Azienda Ospedaliera Maggiore Della Carita | |
| Novara, Italy, 28100 | |
| Universita di Palermo | |
| Palermo, Italy, 90141 | |
| Istituto Scientifico H. San Raffaele | |
| Milano, Italy, 20132 | |
| Spedali Civili | |
| Brescia, Italy, 25124 | |
| Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino | |
| Torino, Italy, 10126 | |
| Netherlands | |
| Academisch Medisch Centrum | |
| Amsterdam, Netherlands, 1105 AZ | |
| Academisch Ziekenhuis Groningen | |
| Groningen, Netherlands, 9713 GZ | |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | |
| Rotterdam, Netherlands, 3008 AE | |
| Jeroen Bosch Ziekenhuis | |
| 's-Hertogenbosch, Netherlands, 5211 NL | |
| Onze Lieve Vrouwe Gasthuis | |
| Amsterdam, Netherlands, 1091 HA | |
| University Medical Center Rotterdam at Erasmus Medical Center | |
| Rotterdam, Netherlands, 3000 CA | |
| St. Elisabeth Ziekenhuis | |
| Tilburg, Netherlands, 5022 GC | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Rijnstate Hospital | |
| Arnhem, Netherlands, 6800 TA | |
| Norway | |
| Norwegian Radium Hospital | |
| Oslo, Norway, N-0310 | |
| Romania | |
| Inselspital, Bern | |
| Bucarest, Romania, RO 72435 | |
| Institute of Oncology - Bucarest | |
| Bucarest, Romania, RO 72435 | |
| Turkey | |
| Dokuz Eylul University School of Medicine | |
| Izmir, Turkey, 35340 | |
| Marmara University Hospital | |
| Istanbul, Turkey, 81190 | |
| United Kingdom, England | |
| Bristol Haematology and Oncology Centre | |
| Bristol, England, United Kingdom, BS2 8ED | |
| United Kingdom, Wales | |
| University of Wales College of Medicine | |
| Cardiff, Wales, United Kingdom, CF14 4XN | |
| Velindre Cancer Center at Velinde Hospital | |
| Cardiff, Wales, United Kingdom, CF14 2TL | |
| Investigator: | Neil K. Aaronson, PhD | Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital |
| Investigator: | George Van Andel, MD | Onze Lieve Vrouwe Gasthuis |
More Information
| Study ID Numbers: | CDR0000069463, EORTC-15011, EORTC-30011 |
| Study First Received: | July 8, 2002 |
| Last Updated: | August 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00041301 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |