Full Text View
Tabular View
No Study Results Posted
Related Studies
Assessing Quality of Life of Patients With Prostate Cancer
This study is ongoing, but not recruiting participants.
First Received: July 8, 2002   Last Updated: August 19, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2002
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041301

  Hide Study Locations
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
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Investigator: Neil K. Aaronson, PhD Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Investigator: George Van Andel, MD Onze Lieve Vrouwe Gasthuis
  More Information

Additional Information:
Publications:
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

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009