Assessing Quality of Life of Patients With Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00041301
• Other study ID #: EORTC-15011-30011
• Secondary ID: EORTC-15011EORTC
• Status: Completed
• Phase: N/A
• First received: July 8, 2002
• Last updated: August 24, 2012
• Start date: March 2002
• Est. completion date: November 2005

Study information

• Verified date: August 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 625
• Est. completion date: November 2005
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• QoL assessment
qol questionnaires

Locations

Country	Name	City	State
Australia	Sir Charles Gairdner Hospital - Perth	Perth	Western Australia
Belgium	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
Denmark	Rigshospitalet	Copenhagen
France	Hopital Jean Bernard	Poitiers
Germany	Universitaetsklinikum Bonn	Bonn
Germany	Universitaets-Krankenhaus Eppendorf	Hamburg
Italy	Spedali Civili	Brescia
Italy	Istituto Scientifico H. San Raffaele	Milano
Italy	Azienda Ospedaliera Maggiore Della Carita	Novara
Italy	Universita di Palermo	Palermo
Italy	Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino	Torino
Netherlands	Jeroen Bosch Ziekenhuis	's-Hertogenbosch
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Academisch Ziekenhuis Groningen	Groningen
Netherlands	University Medical Center Nijmegen	Nijmegen
Netherlands	Daniel Den Hoed Cancer Center at Erasmus Medical Center	Rotterdam
Netherlands	University Medical Center Rotterdam at Erasmus Medical Center	Rotterdam
Netherlands	St. Elisabeth Ziekenhuis	Tilburg
Norway	Norwegian Radium Hospital	Oslo
Romania	Inselspital, Bern	Bucarest
Romania	Institute of Oncology - Bucarest	Bucarest
Turkey	Marmara University Hospital	Istanbul
Turkey	Dokuz Eylul University School of Medicine	Izmir
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	University of Wales College of Medicine	Cardiff	Wales
United Kingdom	Velindre Cancer Center at Velinde Hospital	Cardiff	Wales

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Australia,  Belgium,  Denmark,  France,  Germany,  Italy,  Netherlands,  Norway,  Romania,  Turkey,  United Kingdom, 

References & Publications (2)

Arraras JI, Villafranca E, Arias de la Vega F, Romero P, Rico M, Vila M, Asín G, Chicata V, Domínguez MA, Lainez N, Manterola A, Martínez E, Martínez M. The EORTC Quality of Life Questionnaire for patients with prostate cancer: EORTC QLQ-PR25. Validation — View Citation

Arraras Urdaniz JI, Villafranca Iturre E, Arias de la Vega F, Domínguez Domínguez MA, Lainez Milagro N, Manterola Burgaleta A, Martínez Lopez E, Romero Rojano P, Martínez Aguillo M. The eortc quality of life questionnaire QLQ-C30 (version 3.0). Validation — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychometric validity of the PR25 module	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.	No
Secondary	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	No