The Heidelberg Decision Aid for Patients With Lung Cancer (HELP)—Findings of a Randomized Controlled Trial.

Abstract

Background: Advanced lung cancer typifies the challenges of shared decision-making in oncology. With a limited prognosis for survival, the increasingly numerous and complex treatment options must continually be weighed against issues of fragility, quality of life, and the end of life.

Methods: This randomized, controlled trial, carried out on 138 patients, concerned the use of a decision aid combined with decision coaching, versus standard care. The primary endpoint was clarity of the patient's personal attitude, as assessed on the Decisional Conflict Scale. The secondary endpoints were self-efficacy, decisional conflict, perceived preparedness and participation in decision-making, and anxiety/depression. The data were analyzed with descriptive statistics and intergroup comparisons. The trial was entered into the German registry of clinical trials (DRKS00028023).

Results: No statistically significant difference with regard to the primary endpoint (clarity of the patient's personal attitude concerning the decision) was found in a comparison between the intervention group and the control group (IG: median/IQR: 41.67/47.92; CG: median/IQR: 33.33/43.75; p = 0.35). The descriptive statistics revealed a high level of decisional conflict in the overall group of study participants: 57.6% had a very high level of decisional conflict, composed in particular of the dimensions of feeling inadequately informed (64.4%) and of uncertainty (58.9%). Most participants judged the intervention to be helpful in preparing them to make a decision.

Conclusion: Even though the intervention was perceived as helpful preparation for decision-making, it did not bring about any improvement in the high level of decisional conflict. With the continual development of new treatments and the associated increase in prognostic uncertainty, there is an important role for individualized patient information and the training of physicians in how to deal with uncertainty.