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

Purpose: 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.

Materials And Methods: 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.

Results: 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.

Conclusion: 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.