School of Creative Arts Therapies, University of Haifa, Haifa, Israel
Emili Sagol Creative Arts Therapies Research Center, University of Haifa Faculty of Social Welfare and Health Sciences, Haifa, Israel.
BMJ Open. 2020 Nov 19;10(11):e037521. doi: 10.1136/bmjopen-2020-037521.
Patients with breast cancer (BC) cope with depression which is linked to functional limitations in survivorship and to physical symptoms. Pain and fatigue are prominent symptoms that affect the well-being of cancer survivors. Emotional processing has been associated with improved physical and psychological health in survivors. Art therapy is a form of psychotherapy that involves the use of visual art-making for expression and communication. It encourages emotional processing and has been linked to symptom reduction in patients with cancer. This protocol is designed to examine two mechanistic changes: emotional processing (awareness, expression and acceptance) and cholinergic anti-inflammatory processes (heart rate variability and cytokine expression) through which an art therapy intervention may reduce depression, pain and fatigue. In addition, we will examine ethnocultural differences in the effect of art therapy in women from different ethnocultural backgrounds.
A randomised controlled study with careful controls will randomise 240 patient with BC (50% Jewish and 50% Arab) to an 8-week group art therapy intervention or an 8-week Mandala colouring comparison group. This design will test the mechanisms of art therapy on the targeted outcomes beyond the effects of time with a group, focus on a task and engagement with art materials. We will examine two potential mechanisms: emotional processing and cholinergic anti-inflammatory processes; of the intervention effects on depression, pain and fatigue and compare these effects in Arab versus Jewish women.
Participants will sign informed consent before participation and will be informed that they can leave the study at any point in time without effect on their medical treatment. The Helsinki committees of each participating hospital have approved the study. Data collected in this study will be published in peer-review journals, and we will use the platform of the study website (http://repat.haifa.ac.il/en/) for further dissemination to the general public.
The study is registered in ClinicalTrials.gov: NCT03377816; Pre-results.
患有乳腺癌（BC）的患者会出现抑郁症状，这与生存者的功能受限和身体症状有关。疼痛和疲劳是影响癌症幸存者幸福感的突出症状。情绪处理与幸存者的身心健康改善有关。艺术治疗是一种心理治疗形式，涉及使用视觉艺术创作来表达和交流。它鼓励情绪处理，并与癌症患者的症状减轻有关。本方案旨在研究两种机制变化：通过艺术治疗干预可能减轻抑郁、疼痛和疲劳的情绪处理（意识、表达和接受）和胆碱能抗炎过程（心率变异性和细胞因子表达）。此外，我们将研究艺术治疗对不同种族背景的女性的影响的种族文化差异。
一项随机对照研究将对 240 名 BC 患者（50%犹太人和 50%阿拉伯人）进行随机分组，分别接受 8 周的团体艺术治疗干预或 8 周的曼陀罗填色对照组。这种设计将测试艺术治疗对目标结果的机制，而不仅仅是时间、小组、关注任务和艺术材料参与的影响。我们将研究两种潜在的机制：情绪处理和胆碱能抗炎过程；干预对抑郁、疼痛和疲劳的影响，并比较阿拉伯人和犹太人女性的这些影响。
参与者在参与前将签署知情同意书，并被告知他们可以随时离开研究，而不会影响他们的治疗。每个参与医院的赫尔辛基委员会都批准了这项研究。本研究中收集的数据将发表在同行评议期刊上，我们将使用研究网站（http://repat.haifa.ac.il/en/）的平台向公众进一步传播。
该研究在 ClinicalTrials.gov 注册：NCT03377816；预结果。
