Assessing Quality of Life of Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00041301|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 27, 2012
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.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Other: QoL assessment|
- 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|
|Actual Enrollment :||625 participants|
|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 Start Date :||March 2002|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||November 2005|
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041301
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|Study Chair:||Neil K. Aaronson, PhD||The Netherlands Cancer Institute|
|Principal Investigator:||George Van Andel, MD||Onze Lieve Vrouwe Gasthuis|