This article was originally published here
BMJ open. 2022 Apr 25;12(4):e059960. doi: 10.1136/bmjopen-2021-059960.
INTRODUCTION: Complementary and alternative medicine (CAM) has been shown to reduce symptoms and side effects and improve quality of life for patients undergoing conventional oncology treatment, but CAM can also cause symptoms and side effects such as headaches and fatigue. Thus, patients need guidance for safe and healthy use of CAMs. According to published results, an open dialogue about CAMs (OD-CAMs) between healthcare professionals and patients as an integral part of cancer treatment can improve patients’ quality of life and well-being. Since the literature on the issue is scarce, the objective of this study is to evaluate the effectiveness of OD-CAM integrated early in conventional oncology treatment versus standard care (SC) in patients undergoing standard anti-cancer treatment.
METHODS AND ANALYSIS: The study is a randomized controlled trial, conducted at an outpatient oncology clinic in Denmark. 207 patients under curative or palliative oncological treatment for breast, gynecological, prostate, pulmonary, colorectal, anal or pancreatic cancer will be randomized to SC with or without OD-CAM. A specialized nurse will lead 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, major concerns and decision regret at 8, 12, and 24 weeks after enrollment, and overall survival.
ETHICS AND DISSEMINATION: According to the Health Research Ethics Committee for Southern Denmark, ethics approval for this study is not required (S-20202000-5, 20/1019). The Region of Southern Denmark (Journal No. 20/11100) has approved the storage and processing of data. Informed consent from participants will be obtained prior to inclusion and randomization. The results of the study, whether positive, negative or inconclusive, will be disseminated through open access and peer-reviewed publications, stakeholder reports and presentations at relevant conferences.
TEST REGISTRATION NUMBER: NCT04299451.