Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark
Oncology, Lillebaelt Hospital - University Hospital of Southern Denmark, Vejle, Denmark.
BMJ Open. 2022 Apr 25;12(4):e059960. doi: 10.1136/bmjopen-2021-059960.
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.
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.
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.
NCT04299451.
补充和替代医学（CAM）已被证明可以减轻接受常规肿瘤治疗的患者的症状和不良反应，提高其生活质量，但 CAM 也可能导致头痛和疲劳等症状和不良反应。因此，患者需要在 CAM 的使用方面得到安全和健康的指导。根据已发表的研究结果，将健康专业人员与患者之间关于 CAM 的开放对话（OD-CAM）作为癌症治疗的一个组成部分，可能会提高患者的生活质量和幸福感。由于该问题的文献很少，因此本研究的目的是评估将 OD-CAM 早期整合到常规肿瘤治疗中与标准护理（SC）相比，在接受标准抗癌治疗的患者中的疗效。
这是一项在丹麦肿瘤门诊进行的随机对照试验。将 207 名正在接受乳腺癌、妇科、前列腺癌、肺癌、结直肠癌、肛门癌或胰腺癌的根治性或姑息性肿瘤治疗的患者随机分配至 SC 加或不加 OD-CAM。一名护士专家将在一到两次会议中促进 OD-CAM。主要终点是在入组后 8 周时患者报告的与心理幸福感相关的生活质量。次要终点是患者报告的抑郁和焦虑水平、主要关注点、入组后 8、12 和 24 周时的决策后悔以及总生存。
根据南丹麦健康研究伦理委员会的规定，本研究不需要伦理批准（S-20202000-5，20/1019）。南丹麦地区（期刊号 20/11100）批准了数据的存储和处理。在纳入和随机分组之前，将获得参与者的知情同意。研究结果，无论积极、消极还是不确定，都将通过开放获取、同行评议的出版物、利益相关者报告和相关会议的演示进行传播。
NCT04299451。
