CAMONCO 2: Results From a Randomized Controlled Trial Comparing Open Dialogue About Complementary Alternative Medicine and Standard Care on Patients' Quality of Life.

Abstract

This randomized controlled trial aimed to investigate the impact of OD-CAM on patients' quality of life (QoL), emotional well-being, decision regret, and survival. Patients undergoing antineoplastic treatment were randomly allocated to receive standard care (SC) plus OD-CAM or SC alone. The primary end point was patient-reported QoL 8 weeks after enrollment. Secondary end points included patient-reported QoL, anxiety, depression, and decision regret at 12 and 24 weeks after enrollment and overall survival at 52 weeks after enrollment. Patient-reported outcomes were evaluated using the European Organisation for Research and Treatment of Cancer Computer Adaptive Test Core questionnaire, the Hospital Anxiety and Depression questionnaire, and the Decision Regret Scale. A total of 210 patients were equally randomly assigned, leaving 105 patients in each group. No significant differences were observed in QoL, well-being, decision regret, or survival between the groups. OD-CAM did not demonstrate superiority over SC in enhancing the QoL and well-being of patients undergoing antineoplastic treatment. Increased levels of anxiety and fatigue might result from OD-CAM, underscoring the importance of the person-oriented approach inherent in OD-CAM. OD-CAM may hold clinical significance, especially for those already inclined toward CAM; however, further investigation into the essential components of OD-CAM and the characteristics of patients who are most likely to experience significant improvements of OD-CAM is recommended.