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
- 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.
Observational Model: Case-Only, Time Perspective: Prospective
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.
Neil K. Aaronson, PhD
The Netherlands Cancer Institute
United States: Federal Government