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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-15011 | Other Identifier | EORTC | |
| EORTC-30011 | Other Identifier | EORTC |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QoL in prostate cancer | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QoL assessment | Other | qol questionnaires |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| psychometric validity of the PR25 module | Quality of life scores will be evaluated for psychometric validity by:
| before start of treatment, three months after the start of primary treatment and six months after the start of primary treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| debriefing questionnaire information | 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. | at baseline |
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DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Stratum I:
Clinically localized primary prostate cancer
Local or locally advanced primary prostate cancer
Stratum II:
Metastatic prostate cancer
T1-T4, G1-G3, N1, M0-M1 OR
T1-T4, G1-G3, N0-1, M1
Plan to receive hormonal treatment
No cerebral metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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Prostate cancer
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| Name | Affiliation | Role |
|---|---|---|
| Neil K. Aaronson, PhD | The Netherlands Cancer Institute | Study Chair |
| George Van Andel, MD | Onze Lieve Vrouwe Gasthuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Charles Gairdner Hospital - Perth | Perth | Western Australia | 6009 | Australia | ||
| Academisch Ziekenhuis der Vrije Universiteit Brussel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19293053 | Result | Arraras JI, Villafranca E, Arias de la Vega F, Romero P, Rico M, Vila M, Asin G, Chicata V, Dominguez MA, Lainez N, Manterola A, Martinez E, Martinez M. The EORTC Quality of Life Questionnaire for patients with prostate cancer: EORTC QLQ-PR25. Validation study for Spanish patients. Clin Transl Oncol. 2009 Mar;11(3):160-4. doi: 10.1007/s12094-009-0332-z. | |
| 19040169 |
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| Brussels |
| 1090 |
| Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | B-9000 | Belgium |
| Virga Jesse Hospital | Hasselt | 3500 | Belgium |
| Cazk Groeninghe - Campus Maria's Voorzienigheid | Kortrijk | B-8500 | Belgium |
| U.Z. Gasthuisberg | Leuven | B-3000 | Belgium |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Hopital Jean Bernard | Poitiers | 86021 | France |
| Universitaetsklinikum Bonn | Bonn | D-53105 | Germany |
| Universitaets-Krankenhaus Eppendorf | Hamburg | D-20246 | Germany |
| Spedali Civili | Brescia | 25124 | Italy |
| Istituto Scientifico H. San Raffaele | Milan | 20132 | Italy |
| Azienda Ospedaliera Maggiore Della Carita | Novara | 28100 | Italy |
| Universita di Palermo | Palermo | 90141 | Italy |
| Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino | Torino | 10126 | Italy |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | 5211 NL | Netherlands |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | 1091 HA | Netherlands |
| Academisch Medisch Centrum | Amsterdam | 1105 AZ | Netherlands |
| Rijnstate Hospital | Arnhem | 6800 TA | Netherlands |
| Academisch Ziekenhuis Groningen | Groningen | 9713 GZ | Netherlands |
| University Medical Center Nijmegen | Nijmegen | NL-6500 HB | Netherlands |
| University Medical Center Rotterdam at Erasmus Medical Center | Rotterdam | 3000 CA | Netherlands |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | Rotterdam | 3008 AE | Netherlands |
| St. Elisabeth Ziekenhuis | Tilburg | 5022 GC | Netherlands |
| Norwegian Radium Hospital | Oslo | N-0310 | Norway |
| Inselspital, Bern | Bucharest | RO 72435 | Romania |
| Institute of Oncology - Bucarest | Bucharest | RO 72435 | Romania |
| Marmara University Hospital | Istanbul | 81190 | Turkey (Türkiye) |
| Dokuz Eylul University School of Medicine | Izmir | 35340 | Turkey (Türkiye) |
| Bristol Haematology and Oncology Centre | Bristol | England | BS2 8ED | United Kingdom |
| Velindre Cancer Center at Velinde Hospital | Cardiff | Wales | CF14 2TL | United Kingdom |
| University of Wales College of Medicine | Cardiff | Wales | CF14 4XN | United Kingdom |
| Arraras Urdaniz JI, Villafranca Iturre E, Arias de la Vega F, Dominguez Dominguez MA, Lainez Milagro N, Manterola Burgaleta A, Martinez Lopez E, Romero Rojano P, Martinez Aguillo M. The eortc quality of life questionnaire QLQ-C30 (version 3.0). Validation study for Spanish prostate cancer patients. Arch Esp Urol. 2008 Oct;61(8):949-54. doi: 10.4321/s0004-06142008000800017. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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