Descriptive statistics

The flow chart (Fig. 1) shows the number of patients from screening, inclusion and randomization, baseline assessment, second assessment and the final assessment after 4–6 months. Demographic information was compiled for all randomized patients.

Consort diagram

The presentation of the measurements/variables are based on a modified ITT analysis, including all randomized patients with, 1) information at baseline and, 2) at least one post-baseline value for the primary variable FACIT-Sp, and 3) and having been exposed to at least one intervention visit.

The null hypothesis is that there is no difference between EORTC and SEIQoL in the FACIT-Sp score post baseline. The alternative hypothesis is that there is a difference between groups. In order to test the hypothesis a linear mixed model with FACIT-Sp post-baseline scores as the dependent variable and group, time and FACIT-Sp baseline score as fixed covariates was used. Subjects were added as random factors in the model. The contrasts between groups are presented as a point estimate and the corresponding 95% two-sided confidence intervals of the difference. If the 95% confidence interval did not cover 0, the null hypothesis was rejected in favor of the alternative hypothesis.

The secondary endpoints: Global Quality of Life Uniscale (GQL-VAS), Perceived quality of communication (PQC-VAS), Medical Interview Satisfaction Scale (MISS-21) and Patient Global Impression of Change (PGIC) were analyzed using the same statistical model as the primary endpoint.

Time from study baseline to death was analysed using Kaplan-Meier curves based on mortality date retrieved from the Swedish Cause of Death Register. The statistical test used to compare survival curves between the groups was a log rank test.