Assessing Quality of Life of Patients With Prostate Cancer

August 24, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

625

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital - Perth
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium, 1090
        • Academisch Ziekenhuis der Vrije Universiteit Brussel
      • Ghent, Belgium, B-9000
        • Universitair Ziekenhuis Gent
      • Hasselt, Belgium, 3500
        • Virga Jesse Hospital
      • Kortrijk, Belgium, B-8500
        • Cazk Groeninghe - Campus Maria's Voorzienigheid
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • France
      • Poitiers, France, 86021
        • Hopital Jean Bernard
  • Germany
      • Bonn, Germany, D-53105
        • Universitaetsklinikum Bonn
      • Hamburg, Germany, D-20246
        • Universitaets-Krankenhaus Eppendorf
  • Italy
      • Brescia, Italy, 25124
        • Spedali Civili
      • Milano, Italy, 20132
        • Istituto Scientifico H. San Raffaele
      • Novara, Italy, 28100
        • Azienda Ospedaliera Maggiore Della Carita
      • Palermo, Italy, 90141
        • Università di Palermo
      • Torino, Italy, 10126
        • Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5211 NL
        • Jeroen Bosch Ziekenhuis
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum
      • Amsterdam, Netherlands, 1091 HA
        • Onze Lieve Vrouwe Gasthuis
      • Arnhem, Netherlands, 6800 TA
        • Rijnstate Hospital
      • Groningen, Netherlands, 9713 GZ
        • Academisch Ziekenhuis Groningen
      • Nijmegen, Netherlands, NL-6500 HB
        • University Medical Center Nijmegen
      • Rotterdam, Netherlands, 3000 CA
        • University Medical Center Rotterdam at Erasmus Medical Center
      • Rotterdam, Netherlands, 3008 AE
        • Daniel Den Hoed Cancer Center at Erasmus Medical Center
      • Tilburg, Netherlands, 5022 GC
        • St. Elisabeth Ziekenhuis
  • Norway
      • Oslo, Norway, N-0310
        • Norwegian Radium Hospital
  • Romania
      • Bucarest, Romania, RO 72435
        • Institute of Oncology - Bucarest
      • Bucarest, Romania, RO 72435
        • Inselspital, Bern
  • Turkey
      • Istanbul, Turkey, 81190
        • Marmara University Hospital
      • Izmir, Turkey, 35340
        • Dokuz Eylul University School of Medicine
  • United Kingdom
    • England
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 2TL
        • Velindre Cancer Center at Velinde Hospital
      • Cardiff, Wales, United Kingdom, CF14 4XN
        • University of Wales College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Prostate cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: QoL assessment
qol questionnaires
Other Names:
  • QLQ-C30
  • QLQ-PR25

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
psychometric validity of the PR25 module
Time Frame: 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.
before start of treatment, three months after the start of primary treatment and six months after the start of primary treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
debriefing questionnaire information
Time Frame: 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.
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Neil K. Aaronson, PhD, The Netherlands Cancer Institute
  • Principal Investigator: George Van Andel, MD, Onze Lieve Vrouwe Gasthuis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

July 8, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

August 27, 2012

Last Update Submitted That Met QC Criteria

August 24, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-15011-30011
  • EORTC-15011 (Other Identifier: EORTC)
  • EORTC-30011 (Other Identifier: EORTC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on QoL assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe