Efficacy of open dialogue about complementary and alternative medicine compared with standard care in improving quality of life in patients undergoing conventional oncology treatment (CAMONCO 2): protocol for a randomised controlled trial

INTRODUCTION: Complementary and alternative medicine (CAM) has been shown to reduce symptoms and adverse effects and improve quality of life of patients undergoing conventional oncology treatment, but CAM might also cause symptoms and adverse effects such as headache and fatigue. Thus, patients need guidance towards safe and healthy use of CAM. According to published results, open dialogue about CAM (OD-CAM) between health professionals and patients as an integral part of anticancer treatment may improve patients’ quality of life and well-being. Since the literature on the issue is sparse, the aim of this study is to assess the efficacy of OD-CAM integrated early in conventional oncology treatment versus standard care (SC) in patients undergoing standard anticancer treatment. METHODS AND ANALYSIS: The study is a randomised controlled trial, being conducted at an oncology outpatient clinic in Denmark. 207 patients undergoing curative or palliative oncology treatment for breast, gynaecological, prostate, pulmonary, colorectal, anal or pancreatic cancer will be randomly assigned to SC with or without OD-CAM. A nurse specialist will facilitate the OD-CAM in one or two sessions. The primary endpoint is patient reported quality of life in relation to psychological well-being 8 weeks after enrollment. Secondary endpoints are patient reported level of depression and anxiety, top concerns, and decision regret 8, 12 and 24 weeks after enrolment, and overall survival. ETHICS AND DISSEMINATION: According to the Committee on Health Research Ethics for Southern Denmark, ethics approval of this study is not required (S-20202000-5, 20/1019). The Region of Southern Denmark (Journal no. 20/11100) approved the storing and handling of data. Participants’ informed consent will be obtained before inclusion and randomisation. The results of the study, whether positive, negative or inconclusive, will be disseminated through open-access, peer-reviewed publications, stake-holder-reporting and presentations at relevant conferences. TRIAL REGISTRATION NUMBER: NCT04299451.