“艺术疗法在肿瘤学中的应用:癌症患者症状的评估” (ARONCO)
本研究的目的是评估艺术治疗管理对癌症患者在化疗期间对减轻身体或心理症状的影响。
艺术疗法是一种非药物疗法,可以帮助一些患者应对所提供护理之外的癌症后果。
癌症患者常见的心理社会困难是疼痛、疲劳、抑郁、焦虑、嗜睡。 总之,患者在整个疾病期间的幸福感和生活质量。
主要目的是评估艺术疗法作为一种支持性护理对改善癌症治疗(化学疗法、免疫疗法等)后的幸福感的影响,共进行 6 次(两次之间相隔约 24 天) ),在患有癌症病理学的患者中使用两份问卷,一份关于症状评估 (ESAS),另一份关于生活质量 (FACT-G)。
研究概览
详细说明
患者将被随机分为以下几组:
- 第 1 组:在有或没有额外支持治疗的连续 6 次癌症治疗中,艺术疗法作为支持治疗
- 第 2 组:连续 6 次癌症治疗,有或没有额外的支持性护理。
使用埃德蒙顿症状评估系统 (ESAS) 对每位患者进行每次治疗前后的症状评估。
两组(受益于艺术疗法的组和未受益于艺术疗法的组)护理开始和结束时的生活质量FACT-G问卷和艺术疗法贡献问卷,在护理结束时,为艺术治疗组的参与者。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Dordogne
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Périgueux、Dordogne、法国、24000
- Perigueux Hospital Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 18岁以上
- 在肿瘤血液学日接受癌症病理学治疗的患者
- 患者同意
- 社保挂靠患者
排除标准:
- 小病人
- 受法律保护的患者
- 生命和/或认知功能严重受损而无法参与和理解研究的患者
- 可预测管理少于随访期(6 个疗程)的患者,
- 一生中已经参加过艺术治疗的患者
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:用艺术疗法
在有或没有额外支持治疗的连续 6 次癌症治疗中,艺术疗法作为支持治疗
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当患者被安置在治疗室时,护士或ARC建议根据调查图表完成与其就诊对应的问卷,然后取回问卷并转发给艺术治疗师,然后艺术治疗师介入ans 提出了不同的艺术支持:油漆、水彩笔、蜡笔、铅笔、粘土、折纸、音乐作为艺术创作的伴奏。 研讨会从 30 分钟持续到 2:30。 它可以通过医生和护士在医疗过程中的干预来减少。 出于患者注意力集中、服务组织的原因,护理限制设置为 2:30,但患者是其护理的参与者,并选择会话何时结束。 在干预结束时,护士或 ARC 建议患者完成最终问卷。 最后的论文是检索它并将其转发给艺术治疗师。 |
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无干预:没有艺术治疗
连续 6 次癌症治疗,没有艺术治疗,并增加了其他支持性护理。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Average, Over the 6 Treatment Sessions, of the Change in the ESAS 'Well-being" Assessed Before and After Each Treatment Session.
大体时间:Before and after each chimotherapy session - 6 sessions between 6 weeks to 6 months
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The aim is to evaluate the impact of art therapy as a supportive care on the improvement of the well-being felt after a session of cancer treatments (chemotherapy, immunotherapy, ...), during 6 sessions, in patients having a cancerous pathology. The primary endpoint is the 6-session average of the difference between the ESAS score associated with the patient's well-being symptom (a symptom of "feeling good" on the ESAS assessment), obtained before and after the treatment session. The Edmonton Symptom Assessment System (SESA) is a 9-item symptom rating scale. The quote goes from 0 to 10. A score close to zero means a better result. Well-being (0=well, 10=bad) |
Before and after each chimotherapy session - 6 sessions between 6 weeks to 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Average Over the 6 Treatment Sessions of the Difference Between ESAS Scores for Each One of the Other Symptoms, Measured Before and After Each Treatment Session
大体时间:Before and after each chemotherapy session - 6 sessions between 6 weeks to 6 months
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For each of the other symptoms of the ESAS scale, : pain, fatigue, nausea, depression, anxiety, drowsiness, lack of appetite, difficulty breathing, the average over 6 treatment sessions, the difference between the ESAS score associated with the symptom studied, obtained before and after each treatment session. The Edmonton Symptom Assessment System (SESA) is a 9-item symptom rating scale. The quote goes from 0 to 10. For symptoms assessed within the 1st secondary endpoint, the ESAS score correlates positively to symptom intensity. |
Before and after each chemotherapy session - 6 sessions between 6 weeks to 6 months
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Difference in ESAS Scores for Each Symptom Between the First Treatment Session and the Last (6th) Session.
大体时间:6 sessions between 6 weeks to 6 months
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To determine the impact of the 6 sessions of art therapy as supportive care to cancer treatments on the evolution of symptoms, by the ESAS scale, before the first session of art therapy, and after the last session (6th) The secondary judgment criterion 2 corresponds, for each of the ESAS symptoms, to the difference in ESAS score associated with the symptom studied, before the first and the last treatment session (6th). The Edmonton Symptom Assessment System (SESA) is a 9-item symptom rating scale. The quote goes from 0 to 10. Symptom intensity (0-10) and for well-being a score close to zero means a better result. |
6 sessions between 6 weeks to 6 months
|
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Difference in the Total FACT-G Quality-of-life Score Between the First Session and the End of the 6 Anticancer Treatment Sessions.
大体时间:6 sessions between 6 weeks to 6 months
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Secondary endpoint 3 is the difference in total FACT-G quality of life score score between inclusion and the end of the 6 sessions of cancer treatment. This questionnaire contains 27 items constructed on a Likert scale with 5 coded response modes: 0 "Not at all" / 1 "A little" / 2 "Moderately" / 3 "A lot" / 4 "Enormously". A score is calculated by dimension ( physical, social, emotional and functional). These scores range from 0 to 28 where 0 represents a low level of well-being and 28 a high level of well-being. This score corresponds to the sum of the raw scores obtained for each dimension, and varies from 0 (low level) to 108 (good level of general well-being). Score global FACT-G (0-108) |
6 sessions between 6 weeks to 6 months
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Participants' Satisfaction With Art Therapy as Well as Their Subjective Perception of the Effects Experienced During and After the Sessions
大体时间:End of 6 session between 6 weeks to 6 months
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Questionnaire (created by the principal investigator) designed to evaluate patient satisfaction, after 6 sessions of art therapy, on this type of therapy as supportive treatment in onco-therapy.
It is composed of 5 questions relating to the feeling of art therapy sessions by the patient.
They are rated from 0 to 5 (a better score is close to 5) in relation The secondary endpoint 4 is the satisfaction questionnaire for art therapy, performed only in patients in the therapy group by art.
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End of 6 session between 6 weeks to 6 months
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合作者和调查者
调查人员
- 首席研究员:Elodie EP BARBUT PAILLARD, SEARCHER、Hospital center of Périgueux
出版物和有用的链接
一般刊物
- Conroy T, Mercier M, Bonneterre J, Luporsi E, Lefebvre JL, Lapeyre M, Puyraveau M, Schraub S. French version of FACT-G: validation and comparison with other cancer-specific instruments. Eur J Cancer. 2004 Oct;40(15):2243-52. doi: 10.1016/j.ejca.2004.06.010.
- Schiltz L, Zimoch A. [Using arts therapies in psycho-oncology: evaluation of an exploratory study implemented in an out-patient setting]. Bull Soc Sci Med Grand Duche Luxemb. 2013;(1):48-71. French.
- Gotze H, Geue K, Buttstadt M, Singer S, Schwarz R. [Art therapy for cancer patients in outpatient care. Psychological distress and coping of the participants]. Forsch Komplementmed. 2009 Feb;16(1):28-33. doi: 10.1159/000191211. Epub 2009 Jan 30. German.
- Puetz TW, Morley CA, Herring MP. Effects of creative arts therapies on psychological symptoms and quality of life in patients with cancer. JAMA Intern Med. 2013 Jun 10;173(11):960-9. doi: 10.1001/jamainternmed.2013.836.
- Nainis N, Paice JA, Ratner J, Wirth JH, Lai J, Shott S. Relieving symptoms in cancer: innovative use of art therapy. J Pain Symptom Manage. 2006 Feb;31(2):162-9. doi: 10.1016/j.jpainsymman.2005.07.006.
- Geue K, Goetze H, Buttstaedt M, Kleinert E, Richter D, Singer S. An overview of art therapy interventions for cancer patients and the results of research. Complement Ther Med. 2010 Jun-Aug;18(3-4):160-70. doi: 10.1016/j.ctim.2010.04.001. Epub 2010 May 15.
- Bruera E, MacMillan K, Hanson J, MacDonald RN. The Edmonton staging system for cancer pain: preliminary report. Pain. 1989 May;37(2):203-209. doi: 10.1016/0304-3959(89)90131-0.
- Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
- Wood MJ, Molassiotis A, Payne S. What research evidence is there for the use of art therapy in the management of symptoms in adults with cancer? A systematic review. Psychooncology. 2011 Feb;20(2):135-45. doi: 10.1002/pon.1722.
- Lefevre C, Ledoux M, Filbet M. Art therapy among palliative cancer patients: Aesthetic dimensions and impacts on symptoms. Palliat Support Care. 2016 Aug;14(4):376-80. doi: 10.1017/S1478951515001017. Epub 2015 Nov 20.
- Rhondali W, Lasserre E, Filbet M. Art therapy among palliative care inpatients with advanced cancer. Palliat Med. 2013 Jun;27(6):571-2. doi: 10.1177/0269216312471413. No abstract available.
- Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991 Summer;7(2):6-9.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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