ISSN:
1569-8041
Keywords:
clinical trials
;
methodology
;
ovarian cancer
;
quality of life
;
study design
Source:
Springer Online Journal Archives 1860-2000
Topics:
Medicine
Notes:
Abstract Background:The pattern of symptoms experienced by cancer patientsduring chemotherapy is very complex. Consequently, quality of life (QOL)assessment has to be carefully planned to capture clinically relevant changes. Patients and methods:A clinical model of changes in symptomsexperienced by symptomatic metastatic patients during several courses ofchemotherapy has been developed. The model differentiates cancer-relatedsymptoms, acute side-effects, chronic side-effects and symptoms not relatedto cancer. The model was used to predict changes in each of these four symptomgroups. Three time points were selected (post-cycle 2, pre-cycle 3, post-cycle5) and an appropriate window around each time point was set. The modelpredictions were tested empirically with 56 patients with advanced ovariancancer who completed the EORTC QLQ-C30 plus disease specific items during asix-cycle course of chemotherapy. Results:The changes observed in the sample were in accordancewith the changes predicted by the clinical model. Results from patients whodid not complete the questionnaire within the specified time windows tendedto dilute the findings from the group who did. Conclusions:A clinical model is useful in the planning of QOLassessments in order to capture clinically relevant effects. Such models alsofacilitate the interpretation of QOL studies, particularly when cyclicshort-term effects and chronic side-effects are overlaid on disease symptoms,as is the case with chemotherapy for cancer.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1023/A:1008394107982
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