Development of a disease specific quality of life (QoL) questionnaire module to supplement the EORTC core cancer QoL questionnaire, the QLQ-C30 in patients with pancreatic cancer

Abstract

There is overwhelming consensus that quality of life assessment is urgently required in pancreatic cancer, yet little research has been conducted. We report on the development of a disease specific questionnaire module to supplement the EORTC core cancer module, the QLQ-C30 in patients with pancreatic cancer, using EORTC quality of life study group guidelines for module development. Relevant QoL issues were generated from literature searches and interviews with health professionals and patients with pancreatic cancer. Issues were constructed into items and provisionally translated. The provisional module was pretested in patients in 8 European centres. The resulting module the QLQ-PAN26 includes 26 items related to disease symptoms, treatment side-effects and emotional issues specific to pancreatic cancer. This should ensure that the module will be sensitive to assess the small but important disease and treatment related QoL changes in pancreatic cancer. The use of the QLQ-C30 and QLQ-PAN26 will provide a comprehensive system of QoL assessment in international trials of pancreatic cancer.;

Introduction

The outlook for a patient diagnosed with pancreatic adenocarcinoma remains gloomy in terms of prognosis and survival, with over 90% dying within a year of diagnosis[1]. Treatment options remain limited. Only 20% of patients may be suitable candidates for a ‘curative resection', with only 15–20% of these patients surviving beyond 5 years. The majority of patients receive palliative surgical or medical interventions. The roles of chemotherapy and radiotherapy remain a source of debate within the literature[2]and any benefit in terms of gain in survival time and alleviation of symptoms must be balanced against the costs of treatment toxicity and any deterioration in quality of life (QoL). There is overwhelming consensus that QoL assessment is urgently required in pancreatic cancer3, 4, 5. However, little research has been published and to our knowledge no disease specific questionnaire has been described in the literature.

The EORTC Quality of Life study group have developed a modular approach to the development of QoL questionnaires specifically designed for the clinical trial situation[6]. A 30 item core cancer questionnaire, the QLQ-C30 has been developed. This is intended to be supplemented by additional modules to assess specific disease and treatment related QoL issues, in particular patient subgroups. This approach facilitates generalisability of results across studies and the sensitivity to detect small but clinically meaningful differences in QoL to address specific research questions. To ensure scientific rigour, detailed guidelines for module development have been published[7], and recently updated[8]. We describe the first three phases of the development of a pancreatic cancer specific module to supplement the EORTC QLQ-C30.