NCT00041301

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
625

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2002

Typical duration for all trials

Geographic Reach
11 countries

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2002

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

August 27, 2012

Status Verified

August 1, 2012

Enrollment Period

2.8 years

First QC Date

July 8, 2002

Last Update Submit

August 24, 2012

Conditions

Prostate Cancer

Keywords

stage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • debriefing questionnaire information

    at baseline

Study Arms (1)

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

Interventions

QoL assessmentOTHER

qol questionnaires

Also known as: QLQ-C30, QLQ-PR25
QoL in prostate cancer

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prostate cancer

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (33)

Sir Charles Gairdner Hospital - Perth

Perth, Western Australia, 6009, Australia

Location

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, 1090, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

Virga Jesse Hospital

Hasselt, 3500, Belgium

Location

Cazk Groeninghe - Campus Maria's Voorzienigheid

Kortrijk, B-8500, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Hopital Jean Bernard

Poitiers, 86021, France

Location

Universitaetsklinikum Bonn

Bonn, D-53105, Germany

Location

Universitaets-Krankenhaus Eppendorf

Hamburg, D-20246, Germany

Location

Spedali Civili

Brescia, 25124, Italy

Location

Istituto Scientifico H. San Raffaele

Milan, 20132, Italy

Location

Azienda Ospedaliera Maggiore Della Carita

Novara, 28100, Italy

Location

Universita di Palermo

Palermo, 90141, Italy

Location

Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

Torino, 10126, Italy

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5211 NL, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Rijnstate Hospital

Arnhem, 6800 TA, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9713 GZ, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

University Medical Center Rotterdam at Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

St. Elisabeth Ziekenhuis

Tilburg, 5022 GC, Netherlands

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Inselspital, Bern

Bucharest, RO 72435, Romania

Location

Institute of Oncology - Bucarest

Bucharest, RO 72435, Romania

Location

Marmara University Hospital

Istanbul, 81190, Turkey (Türkiye)

Location

Dokuz Eylul University School of Medicine

Izmir, 35340, Turkey (Türkiye)

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Velindre Cancer Center at Velinde Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

University of Wales College of Medicine

Cardiff, Wales, CF14 4XN, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 19293053RESULT

  • 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.

    PMID: 19040169RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Neil K. Aaronson, PhD

    The Netherlands Cancer Institute

    STUDY CHAIR

  • George Van Andel, MD

    Onze Lieve Vrouwe Gasthuis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2002

First Posted

January 27, 2003

Study Start

March 1, 2002

Primary Completion

December 1, 2004

Study Completion

November 1, 2005

Last Updated

August 27, 2012

Record last verified: 2012-08

Locations

TU(2)GB(3)NL(9)AU(1)DE(2)FR(1)NO(1)DK(1)IT(5)BE(6)RO(2)