Evaluation of the Medical Service by Socio-aesthetics in Oncology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 6
- 主要终点
- Patient Centricity Questionnaire (PCQ): Patient reported outcome: impact of supportive care
研究概览
简要总结
the 3-year randomized controlled RCT-SE study aims to investigate Socio-aesthetics well being care on quality of life, pain and anxiety.
The primary objective is to show that socio-aesthetics well being care improves quality of life during cancer treatment, compared to self care administration of dermo-cosmetics products
The secondary objectives are to show that socio-aesthetics well being care significantly reduced anxiety and pain compared to self care administration of dermo-cosmetics products
详细描述
Socio-aesthetics care is the delivery appropriate beauty care in a population weakened by a physical, psychological and/or social attack.
this well-being care is imperfectly assessed with few data from randomized controlled trials.
The RCT-STudy is a randomized, controlled, multicenter, open label, intervention study that will be conducted among 400 patients treated with chemotherapy for breast, prostate, colon and lung cancer.
Patients will be randomly assigned to one of the two arms of the study according to a 1:1 ratio:
- Group A will benefit from 4 sessions of well being care performed by a qualified socio-aesthetic person, with dermo-cosmetics product defined, during 4 consecutive chemotherapy administrations .
- Group B (control) will apply the same dermo-cosmetics products themselves (self-care) without intervention of socio-aesthetic, during 4 consecutive chemotherapy administrations
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
- None
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
- •over 18 years old
- •treated with chemotherapy for lung , breast, colon or prostate cancer
- •Able to understand, read, and write French,
- •Affiliated with a social security scheme,
- •Having dated and signed an informed consent.
排除标准
- •Unable to be followed for medical, social, family, geographic or psychological reasons for the duration of the study,
- •Deprived of their liberty by court or administrative decision,
研究组 & 干预措施
group A: well-being care performed by SOCIO-AESTHETICS
Group A will benefit from 4 sessions of well being care performed by a qualified socio-aesthetics, during 4 consecutive chemotherapy administrations.
Patients included will have following interventions :
quality of life: PCQ Pain: EVA Anxiety: HADS
干预措施: SOCIO-AESTHETICS care (Other)
group B: control
Group B (control) will apply the dermo-cosmetic products themselves (self-care) without intervention of the socio-aesthetician, during 4 consecutive chemotherapy administrations.
quality of life: PCQ Pain: EVA Anxiety: HADS
结局指标
主要结局
Patient Centricity Questionnaire (PCQ): Patient reported outcome: impact of supportive care
时间窗: up to 12 weeks
Patient Centricity Questionnaire (PCQ): (0-110) higher scores mean better outcome
次要结局
- pain EVA(up to 12 weeks)
- Anxiety(up to 12 weeks)