Prostate CancerNCT00041301
Assessing Quality of Life of Patients With Prostate Cancer
An observational study of Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 33 sites in 11 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- QoL assessment
- How many people
- 625 participants
- Where
- 33 sitesin 11 countries
- Study dates
- Mar 2002to Nov 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
33 sites in 11 countries.
33 sites in 11 countries
Netherlands9 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5211 NL
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 HA
Academisch Medisch Centrum
Amsterdam, 1105 AZ
Rijnstate Hospital
Arnhem, 6800 TA
Academisch Ziekenhuis Groningen
Groningen, 9713 GZ
University Medical Center Nijmegen
Nijmegen, NL-6500 HB
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, 3000 CA
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, 3008 AE
St. Elisabeth Ziekenhuis
Tilburg, 5022 GC
Belgium6 sites
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, 1090
Cliniques Universitaires Saint-Luc
Brussels, 1200
Universitair Ziekenhuis Gent
Ghent, B-9000
Virga Jesse Hospital
Hasselt, 3500
Cazk Groeninghe - Campus Maria's Voorzienigheid
Kortrijk, B-8500
U.Z. Gasthuisberg
Leuven, B-3000
Italy5 sites
Spedali Civili
Brescia, 25124
Istituto Scientifico H. San Raffaele
Milan, 20132
Azienda Ospedaliera Maggiore Della Carita
Novara, 28100
Universita di Palermo
Palermo, 90141
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Torino, 10126
United Kingdom3 sites
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Velindre Cancer Center at Velinde Hospital
Cardiff, Wales, CF14 2TL
University of Wales College of Medicine
Cardiff, Wales, CF14 4XN
Germany2 sites
Universitaetsklinikum Bonn
Bonn, D-53105
Universitaets-Krankenhaus Eppendorf
Hamburg, D-20246
Romania2 sites
Inselspital, Bern
Bucharest, RO 72435
Institute of Oncology - Bucarest
Bucharest, RO 72435
Turkey (Türkiye)2 sites
Marmara University Hospital
Istanbul, 81190
Dokuz Eylul University School of Medicine
Izmir, 35340
Australia1 site
Sir Charles Gairdner Hospital - Perth
Perth, Western Australia, 6009
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- QoL assessment
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QoL assessmentOther
Also called QLQ-C30, QLQ-PR25
qol questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: QoL assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2002
- Primary completionDec 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 625 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Neil K. Aaronson, PhD, Study chair, The Netherlands Cancer InstituteGeorge Van Andel, MD, Principal investigator, Onze Lieve Vrouwe Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041301
- Sponsor's protocol ID
- EORTC-15011-30011
- Other IDs
- EORTC-15011, EORTC-30011
- Status last verified
- Aug 2012
- First submitted
- 8 Jul 2002
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19293053Arraras 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.
PubMed 19040169
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00041301
- Acronym / sponsor ID
- EORTC-15011-30011
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 625 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Mar 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QoL in prostate cancer | – | Other: QoL assessmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QoL assessmentAlso: QLQ-C30, QLQ-PR25qol questionnaires | Other | QoL in prostate cancer |
Primary outcome
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.
1 secondary outcome
debriefing questionnaire information
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2012.
- Results publication: PubMed 19293053Arraras 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.
- Results publication: PubMed 19040169Arraras 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil K. Aaronson, PhD study chair
The Netherlands Cancer Institute
George Van Andel, MD principal investigator
Onze Lieve Vrouwe Gasthuis
33 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 33 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Netherlands, Belgium, Italy, United Kingdom, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00041301, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2012.