QUALITY-OF-LIFE IN BREAST-CANCER ADJUVANT THERAPY - VALIDATION AND PILOT TESTING OF A COMBINATION OF QUESTIONNAIRES

Quality of life assessment is important in many breast cancer trials. The validity of quality of life data is crucial. It is now well recogn ized that standardized questionnaires are preferable. However, even th e choice of the most well-tested questionnaire does not guarantee cont ent validity and that the relevant issues are included. This article d escribes the documentation of content validity and the pilot testing o f questionnaires for breast cancer adjuvant trials. To accompany two s tandardized questionnaires (EORTC QLQ-C30 and HADS), we constructed a study-specific questionnaire to cover the topics identified in a liter ature review. Patient interviews largely confirmed the selection of co ntent. In pilot testing, the questionnaires were well accepted, Eviden ce of clinical validity was found. The procedures described are sugges ted as a minimum standard for content validity documentation and feasi bility testing of quality of life questionnaires for clinical trials.