QoL assessment
anxiety/depression, ’
Quality of life analysis will be performed by means of the EORTC QLQ-C30 [EQ-5D is a standardized measure of health status developed by the EuroQol Group. The EQ-5D-5L essentially consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent’s health state. It should be noted that the numerals 1–5 have no arithmetic properties and should not be used as a cardinal score [The EQ VAS records the respondent’s self-rated health on a 20 cm vertical, visual analogue scale (VAS) where the endpoints are labelled ‘the best health you can imagine’ and ‘the worst health you can imagine’. This information can be used as a quantitative measure of health outcome as judged by the individual respondents. Respondents are asked to simply ‘mark an X on the scale to indicate how your health is TODAY’ and then to ‘write the number you marked on the scale in the box below [Results from the EQ-5D-5L descriptive system will be presented as health profile and index values. EQ VAS scores will be presented as mean values with standard deviation.The EORTC QLQ-C30 and EQ-5D-5L questionnaires as paper version will be handed out to and completed by the patient, independently of the study personnel, on Day 1 of the first cycle visit prior to other study measures. Moreover the questionnaires will be handed out to and completed by the patient before each following cycle. The investigator should explain to the patient how to complete the questionnaires but neither he/she nor the research staff can assist the patient with their completion. The patient should complete the questionnaires by him/herself in a quiet place.EORTC QLQ-C30 and EQ-5D-5L questionnaires filled in by the patient at the trial center have to be filed together with the patient’s medical file until the end of study visit in the trial center.