Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Anxiety score by Spielberger questionary
研究概览
简要总结
Patients with acute leukemia or received SCT are hospitalized in protected area, at least for 28 days. In this area, there is some rules like: controlled-visit, protective-clothing….so patient are in social and familial isolation condition.
During their hospitalization, patients are confront to aggressive treatment and psychological distress related to potentially death.
Emergency hospitalization, illness, controlled environment, aggressive treatment and potential complications place patients in a context of anxiety-provoking.
Aesthetic therapy is a new supportive care in cancer therapy access on improving well-being, relaxation and body image.
This supportive care is already used in cancerology department, particularly in breast cancer patients.
In our department, a few patient received aesthetic care during their hospitalization and they appreciated these sessions and impact on well-being was immediately.
Moreover only 6 sessions was proposed and effect on anxiety wasn't measurable Aesthetic care improve well-being but impact on anxiety is unknown. In this study we evaluate the impact off socio aesthetic on the quality off life and anxiety. We evaluate this impact by 3 questionnaires at 3 times during hospitalization.
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 (Participant)
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
- •Patient (male or female) ≥18 years old
- •Hospitalized patient in restricted area than 21 days
- •Patient with acute leukemia (induction or relapse)
- •Patient hospitalized for hematopoietic stem cell transplantation
- •Written Inform consent must be obtained before inclusion and randomization
- •Patient affiliated to and covered by social security for standard care
排除标准
- •Patient hospitalized for another disease
- •Inability to receive study information and/or understand/speak French
- •Inability to give informed consent
- •Legal incapacity (people in jail) or under supervision (i.e. guardianship or curatorship)
- •Already include in this study on a previous hospitalization
结局指标
主要结局
Anxiety score by Spielberger questionary
时间窗: Baseline and Aplasia (between day10 and 14 of hopitalization)
Difference between the 2 Arms on anxiety score (Spielberger questionary: composed of 20 items rated from 1 to 4 points)
次要结局
- Anxiety score by Spielberger questionary(Baseline and day 21 of hospitalization)
- Quality of Life Assessment using the Functional Assessment of Cancer Therapy-Leukemia (FACT-LEU).(Baseline, Aplasia and day 21 of hospitalization)
- Well-being score(Baseline, Aplasia and day 21 of hospitalization)