Assessing Quality of Life of Patients With Prostate Cancer
NCT ID: NCT00041301
Last Updated: 2012-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
625 participants
OBSERVATIONAL
2002-03-31
2005-11-30
Brief Summary
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PURPOSE: Clinical trial to study the effectiveness of two questionnaires in assessing quality of life of patients who have prostate cancer.
Detailed Description
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* 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
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
QoL assessment
qol questionnaires
Interventions
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QoL assessment
qol questionnaires
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed prostate cancer
* Stratum I:
* Clinically localized primary prostate cancer
* T1-T3, G1-G3, N0, M0
* Plan to undergo a radical prostatectomy OR
* Local or locally advanced primary prostate cancer
* T1-T4, G1-G3, N0, M0
* Plan to undergo radiotherapy with curative intent
* 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 anti-androgen monotherapy
* No cerebral metastases
PATIENT CHARACTERISTICS:
Age:
* Any age
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Mentally fit to complete a questionnaire
* Literate in the language of the questionnaires
* No psychological, familial, sociological, or geographical condition that would preclude compliance
* No other concurrent malignancy except basal cell skin cancer
* No concurrent participation in other quality of life investigations that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* See Disease Characteristics
* No prior neoadjuvant hormonal treatment
* Planned adjuvant hormonal therapy (orchiectomy, luteinizing hormone-releasing hormone analogue, or maximal androgen blockade) is allowed for patients in stratum I
Radiotherapy:
* See Disease Characteristics
* No interstitial radiotherapy
* More than 2 years since prior radiotherapy (stratum II)
Surgery:
* See Disease Characteristics
* More than 2 years since prior prostatectomy (stratum II)
Other:
* No prior treatment for prostate carcinoma
18 Years
MALE
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Neil K. Aaronson, PhD
Role: STUDY_CHAIR
The Netherlands Cancer Institute
George Van Andel, MD
Role: PRINCIPAL_INVESTIGATOR
Onze Lieve Vrouwe Gasthuis
Locations
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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
Universitaets-Krankenhaus Eppendorf
Hamburg, , Germany
Spedali Civili
Brescia, , Italy
Istituto Scientifico H. San Raffaele
Milan, , Italy
Azienda Ospedaliera Maggiore Della Carita
Novara, , Italy
Universita di Palermo
Palermo, , Italy
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Torino, , Italy
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Academisch Medisch Centrum
Amsterdam, , Netherlands
Rijnstate Hospital
Arnhem, , Netherlands
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
University Medical Center Nijmegen
Nijmegen, , Netherlands
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, , Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, , Netherlands
St. Elisabeth Ziekenhuis
Tilburg, , Netherlands
Norwegian Radium Hospital
Oslo, , Norway
Inselspital, Bern
Bucharest, , Romania
Institute of Oncology - Bucarest
Bucharest, , Romania
Marmara University Hospital
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University School of Medicine
Izmir, , Turkey (Türkiye)
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Velindre Cancer Center at Velinde Hospital
Cardiff, Wales, United Kingdom
University of Wales College of Medicine
Cardiff, Wales, United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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EORTC-15011
Identifier Type: OTHER
Identifier Source: secondary_id
EORTC-30011
Identifier Type: OTHER
Identifier Source: secondary_id
EORTC-15011-30011
Identifier Type: -
Identifier Source: org_study_id