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12103 Background: In the last decade the therapeutic algorithms in lung cancer have changed dramatically because of the continuous approval of new drugs, leading to steadily improving survival. However, recent studies show that the growing complexity has also led to a negative impact on prognostic awareness and patient-physician communication. In a setting of mostly frail patients, this uncertainty jeopardizes goal-concordant care. Consequently, the guideline recommendations of patient-empowerment and shared decision-making are more important than ever, but evidence-based, comprehensively implemented tools are still lacking. Methods: Randomized controlled, open, mono-center trial (n=138) with two arms: A) use of a decision aid incl. clarification of personal values accompanied by a decision-coaching session vs. B) usual care; stratified block randomization according to the characteristic of preferred decision-making at baseline; primary endpoint: clarity of personal values (Value Clarity Subscale of the Decisional Conflict Scale). Secondary outcomes: patients' self-efficacy (DSES), decisional conflict (DCS), perceived preparation for and involvement in decision-making (PDMS and PICS), general health and emotional state (EQ-5D-5L and HADS). In addition to the descriptive evaluation, group comparisons between the two arms were performed (non-parametric comparison: van Elteren test). Results: The evaluation showed high values for decisional conflict in both groups (total mean score arm A 41,25 and arm B 38,65), exposing relevant conflict in 57,6% of patients, highest in the subscale for information (64,4%) and uncertainty (58,9%). PDMS showed that most patients considered the intervention helpful (“prepare for the next visit with your doctor”: 83,8%, “prepare to talk to your doctor about what matters most to you”: 81,6%, “help to know that decision depends on what matters most to you”: 81,6%). The PICS-subscale “patient information” (active information-seeking behavior) showed a statistically significant difference between the two groups (arm A: 2,86 vs arm B: 3,12; p=0,048). All other outcomes showed no significant differences with equally high DCS scores in both arms’ follow-up. Conclusions: Patients with advanced lung cancer show a strikingly high decisional conflict. Despite successfully empowering perceived preparation for decision-making and decreasing information needs in the encounter with the physician, the intervention was not strong enough to improve significantly the decisional conflict. In a setting of constantly changing oncological information and increasing prognostic uncertainty, tailored support that flexibly adapts to individual needs in decision-making is urgently needed. Clinical trial information: DRKS00028023 .
Villalobos et al. (Sat,) studied this question.