Clinical trial NCT00041301: Assessing Quality of Life of Patients With Prostate Cancer
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-01-27
Enrollment: 625
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate cancer

Brief summary: 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.

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 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

Primary outcomes:
measure: psychometric validity of the PR25 module
timeFrame: before start of treatment, three months after the start of primary treatment and six months after the start of primary treatment.
Secondary outcomes:
measure: debriefing questionnaire information
timeFrame: at baseline
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital - Perth
state: Western Australia
city: Brussels
country: Belgium
facility: Academisch Ziekenhuis der Vrije Universiteit Brussel
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Hasselt
country: Belgium
facility: Virga Jesse Hospital
city: Kortrijk
country: Belgium
facility: Cazk Groeninghe - Campus Maria's Voorzienigheid
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Poitiers
country: France
facility: Hopital Jean Bernard
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn
city: Hamburg
country: Germany
facility: Universitaets-Krankenhaus Eppendorf
city: Brescia
country: Italy
facility: Spedali Civili
city: Milano
country: Italy
facility: Istituto Scientifico H. San Raffaele
city: Novara
country: Italy
facility: Azienda Ospedaliera Maggiore Della Carita
city: Palermo
country: Italy
facility: Universita di Palermo
city: Torino
country: Italy
facility: Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Groningen
country: Netherlands
facility: Academisch Ziekenhuis Groningen
city: Nijmegen
country: Netherlands
facility: University Medical Center Nijmegen
city: Rotterdam
country: Netherlands
facility: University Medical Center Rotterdam at Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center
city: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis
city: Oslo
country: Norway
facility: Norwegian Radium Hospital
city: Bucarest
country: Romania
facility: Inselspital, Bern
city: Bucarest
country: Romania
facility: Institute of Oncology - Bucarest
city: Istanbul
country: Turkey
facility: Marmara University Hospital
city: Izmir
country: Turkey
facility: Dokuz Eylul University School of Medicine
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
state: England
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Center at Velinde Hospital
state: Wales
city: Cardiff
country: United Kingdom
facility: University of Wales College of Medicine
state: Wales
Study officials:
affiliation: The Netherlands Cancer Institute
name: Neil K. Aaronson, PhD
role: STUDY_CHAIR
affiliation: Onze Lieve Vrouwe Gasthuis
name: George Van Andel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.