Ietje Perfors

97 Adherence The researcher will register whether the Time Out consultation took place and the HON will register the number of contacts with the patient and the content of the contact moment by using a checklist. Participants can discontinue the study on request. Statistical analyses All analysis will be performed following the intention-to-treat principle. Baseline characteristics will be shown by calculating means or medians for continuous variables and frequencies or percentages for categorical variables. Characteristics of patients who complete the study and patients who drop out, will be compared using T-tests for continuous variables and Pearson’s Chi-square analyses for categorical variables. Linear regression analyses will be used for continuous variables adjusted for baseline variables (if measured at baseline) and treating hospital and cancer type. Mixed linear regression modelling adjusted for baseline variables as fixed factors (if measured at baseline) and stratification factors (treating hospital and cancer type) will be used to compare outcomes on repeated follow-up measurements T3 and T5. In these longitudinal analyses, the statistic model accounts for missing data based on the observed data. 30 Differential intervention effects due to sex (men/women), age (≤65/>65 year), personality of type D (defined as ‘scoring high on negative affectivity and social inhibition’ 31 ) (yes/no), type of cancer (breast/lung/colorectal/ gynaecologic/melanoma), co-morbidity (none/1-2/>3) and baseline levels of the outcomes of interest will be explored by adding interaction terms to the regression model. Sample size We assumed a medium effect size (0.5) to be a clinically relevant difference in patients’ satisfaction between the two study groups. Using a power of 0.8 and an alpha less than 0.05, at least 64 patients per study group are required. Accounting for an estimated dropout of 15%, 75 participants in each group are needed. 4