Abstract
INTRODUCTION: Nausea is a difficult symptom to report and measure in clinical trials. We conducted a pilot interview study to improve our understanding of the nausea experience. MATERIALS AND METHODS: Female patients with breast cancer that had experienced nausea during radiation therapy and/or chemotherapy underwent semi-structured interviews that focused on patient-defined and standard definitions, preferences for nausea grading scales, and nausea sub-features: intensity, location, timing/duration, character, associated symptoms, precipitating/alleviating factors, impact on quality of life. RESULTS: 10 patients were interviewed. Patients defined nausea more variably than vomiting and retching/dry heaving. An ordinal grading scale with a 0-10 intensity range was preferred over visual-analogue and qualitative scales. Patients had experienced different intensities of nausea and deemed reporting their worst, average and least intensities feasible. High-intensity episodes were deemed more problematic than low-intensity episodes regardless of their duration. The duration and character of nausea were difficult to describe. A range of associated symptoms, precipitating and alleviating factors were documented. Nausea had a detrimental impact on quality of life. CONCLUSIONS: Nausea has a range of subjective and objective features. Our pilot study provided valuable information that will inform the design of a planned larger survey study. Creating an operational clinical trial definition for nausea appears feasible.