Trial design {8}
EVENT
The HELP-study is designed as a randomized, controlled, open monocenter, two-arm superiority trial with two parallel groups and a primary endpoint of “clarity of personal attitude” as operationalized by the Decisional Conflict Scale (DCS) which will be collected before the decision event. Following the assumptions that the HELP intervention strengthens patient autonomy and their clarity of personal values in relation to the treatment decision, the described design of the two-arm, parallel goups, superiority trials was chosen. Since it can be assumed that the effect of the HELP intervention will differ depending on the participant’s decision style, stratified randomization according to the decision type was chosen in order to take this aspect into account in the group comparisons of the outcome analyses. Therefore, randomization will be performed as stratified block randomization according to the characteristic of preferred decision-making at baseline with a 1:1 allocation.