" Application of Art Therapy in Oncology: Evaluation of the Symptomatic of Patients Suffering From a Cancerous Disease"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 3
- 主要终点
- Evolution well-being felt
研究概览
简要总结
The purpose of this study is to evaluate the impact of art-therapeutic management on a patient with cancer, during chemotherapy treatment, on the reduction of physical or psychological symptoms.
Art therapy is a non-drug approach that can help some patients cope with the consequences of cancer beyond the care provided.
The common psychosocial difficulties experienced by cancer patients are pain, fatigue, depression, anxiety, drowsiness. In sum, the well-being and quality of life of the patient throughout the illness.
The main objective is to evaluate the impact of art therapy, as a supportive care, on improving the well-being felt after a session of cancer treatments (chemotherapy, immunotherapy, ...), during 6 sessions( around 24 days between 2 sessions) , at patients with a cancer pathology using two questionnaires, one on the evaluation of symptoms (ESAS), the other on the quality of life (FACT-G).
详细描述
Patients will be randomized into the following groups:
- Group 1: Art therapy as supportive care in 6 consecutive sessions of cancer treatments with or without additional supportive care
- Group 2: 6 consecutive sessions of cancer treatments with or without additional supportive care.
Symptom assessment with the Edmonton Symptom Assessment System (ESAS) is done before and after each treatment session for each patient.
The FACT-G questionnaire on the quality of life at the beginning and the end of the care for the two groups (group benefiting from the art-therapy and group not benefiting from the art-therapy) and a questionnaire on the contribution of art therapy, at the end of care, for the participants of the art-therapy group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The biostatistician will analyze the two arms blindly
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged over 18
- •patient cared for on Onco-hematology day with a cancerous pathology
- •consent of the patient
- •patient affiliated to social Security
排除标准
- •patient minor
- •patient under legal protection
- •patient with too much impairment of vital and / or cognitive functions to participate and understand the study
- •patient whose predictable management is less than the follow-up period (6 sessions),
- •patient who has already participated in an art therapy session during their lifetime
研究组 & 干预措施
With art therapy
Art therapy as supportive care in 6 consecutive sessions of cancer treatments with or without additional supportive care
干预措施: Art therapy (Behavioral)
Without art therapy
6 consecutive sessions of cancer treatments without art therapy with other supportive care added.
结局指标
主要结局
Evolution well-being felt
时间窗: Before and after each chimotherapy session - 6 sessions between 6 weeks to 6 months
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. The comparison of the mean differences between the ESAS score before and after each of the six cancer treatment sessions according to the two randomization groups will be performed using a generalized linear model.
Average, Over the 6 Treatment Sessions, of the Change in the ESAS 'Well-being" Assessed Before and After Each Treatment Session.
时间窗: Before and after each chimotherapy session - 6 sessions between 6 weeks to 6 months
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)
次要结局
- evaluation of all items on the ESAS scale along 6 sessions(Before and after each chemotherapy session - 6 sessions between 6 weeks to 6 months)
- evaluation of all items on the ESAS scale between first and last session(6 sessions between 6 weeks to 6 months)
- art therapy satisfaction questionary(End of 6 session between 6 weeks to 6 months)
- evolution of the Fact G quality of life assessment items(6 sessions between 6 weeks to 6 months)
- 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(Before and after each chemotherapy session - 6 sessions between 6 weeks to 6 months)
- Difference in ESAS Scores for Each Symptom Between the First Treatment Session and the Last (6th) Session.(6 sessions between 6 weeks to 6 months)
- Difference in the Total FACT-G Quality-of-life Score Between the First Session and the End of the 6 Anticancer Treatment Sessions.(6 sessions between 6 weeks to 6 months)
- Participants' Satisfaction With Art Therapy as Well as Their Subjective Perception of the Effects Experienced During and After the Sessions(End of 6 session between 6 weeks to 6 months)
研究者
Elodie Barbut Paillard
Principal investigator
Centre Hospitalier de Perigueux