A head and neck cancer specific questionnaire module designed to be used in quality of life assessments before, during, and after radiotherapy and surgery, with or without combinations with chemotherapy has been developed in accordance with guidelines given by the EORTC Quality of Life Study Group. Relevant issues were generated by means of literature search, and interviews with specialists and patients. Pre-testing of a preliminary questionnaire module was performed in patients from Norway, Sweden, Denmark, United Kingdom and French-speaking Belgium. The resulting head and neck cancer module, the EORTC QLQ-H&N37, includes 37 items concerning disease and treatment related symptoms, social function and sexuality. By using a combination of the general EORTC QLQ-C30 and the EORTC QLQ-H&N37, health-related quality of life measurements may be compared between studies in different cancer populations, and still be sensitive to changes in the target population.