[Quality of life assessment in pancreatic carcinoma: results of an European multicentric study].

Quality of life (Qol) assessment is a mandatory endpoint of cancer clinical trials. Little research has been conducted on pancreatic cancer (Pc) and no disease specific Qol questionnaire exists. We report on the development of the European Organization for Research and Treatment of Cancer (EORTC) Pc Qol module to supplement the core cancer module (QLQ-C30). Literature research and qualitative interviews with 6 specialists and 34 patients in the UK were followed by construction of a questionnaire, a peer review by international specialists and EORTC. Administration of the QLQ-C 30, a provisional Pc module and a qualitative debriefing interview was performed on 78 patients in 8 countries stratified into groups by disease stage and treatment intention. Pretesting identified that 23/26 questions had an adequate internal reliability (Cronbach's alpha > 0.7) and construct validity (Pearson's r 0.4-0.6). The median time of completion was 12 mins. Qualitative analysis indicates that the module is easy to complete and cross culturally applicable. The EORTC QLO-PAN 26 includes 26 items covering symptoms, body image, sexuality and the emotional and social consequences of Pc. It is intended for use in patients undergoing clinical trials for pancreatic cancer including surgery, chemotherapy and radiotherapy and will allow the detection of small but clinically meaningful differences in clinical trials for Pc.