Impact of Open Dialogue about Complementary Alternative Medicine—A Phase II Randomized Controlled Trial

SIMPLE SUMMARY: A large number of patients with cancer use complementary alternative medicine (CAM), such as diet supplements, massage and acupuncture, as an adjunct to conventional cancer treatment and care. Some types of CAM reduce nausea and vomiting, pain, fear, fatigue and depression, but CAM may also cause new symptoms and side effects. Therefore, it is crucial that cancer patients receive professional guidance on how to use CAM in a safe and healthy manner. Open dialogue about CAM between patients and health professionals is, however, not an integrated part of cancer treatment and care. Therefore, the aim of our study was to assess how open dialogue, including guidance about CAM, affected patients’ safety and health when it was an integrated part of the cancer treatment and care. We found that open dialogue about CAM does not compromise patient safety and that it may improve patients’ quality of life, self-care and survival. ABSTRACT: Complementary alternative medicine (CAM) may reduce the symptom burden of side effects to antineoplastic treatment but also cause new side effects and non-adherence to conventional treatment. The aim of this RCT was to investigate the impact of open dialogue about complementary alternative medicine (OD-CAM) on cancer patients’ safety, health and quality of life (QoL). Patients undergoing antineoplastic treatment were randomly assigned to standard care (SC) plus OD-CAM or SC alone. The primary endpoint was frequency of grade 3–4 adverse events (AE) eight weeks after enrollment. Secondary endpoints were frequency of grade 1–4 AE, QoL, psychological distress, perceived information, attitude towards and use of CAM 12 and 24 weeks after enrollment. Survival was analyzed post hoc. Fifty-seven patients were randomized to the OD-CAM group and fifty-five to the SC group. No significant difference in frequency of grade 3–4 AEs was shown. The same applied to grade 1–4 AEs and QoL, psychological distress and perceived information. A tendency towards better QoL, improved survival and a lower level of anxiety was found in the OD-CAM group. OD-CAM is not superior to SC in reducing the frequency of AEs in patients undergoing antineoplastic treatment. OD-CAM does not compromise patient safety; it may reduce psychological stress and improve QoL and overall survival.