Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy (PASITHEA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Change of mean of the "State Anxiety" score of the State Trait Inventory Anxiety
研究概览
简要总结
The purpose of the study is to assess the average of the "State Anxiety" score of the State Trait Inventory Anxiety at the end of the third cycle of chemotherapy compared to the pre-treatment score (inclusion)
详细描述
As part of this study, patients will be seen 6 times for the purposes of the study: on inclusion, during the first four courses of chemotherapy and at the end of chemotherapy.
The study is offered to the patient during the consultation with the oncologist before the start of chemotherapy. It may possibly be proposed at the latest when he enters hospitalization for chemotherapy.
Two cohorts of patients will be included:
- Patients treated with chemotherapy every 21 days for lung, breast, digestive, colorectal or gynecological cancer;
- Patients treated with chemotherapy every 14 days for digestive or other cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient with cancer treated with adjuvant chemotherapy with an interval of 14 or 21 days for the first 3 cycles;
- •Chemotherapy naïve patient;
- •Patient speaking and understanding French and able to complete the questionnaires;
- •Patient having been informed and having signed an informed consent form to participate in the study.
排除标准
- •Patient who has already benefited from socio-aesthetic care;
- •Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
- •Patient unable to understand the information related to the study (linguistic, psychological, cognitive reasons, etc.);
- •Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
- •Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- •Patient not benefiting from a social security scheme.
结局指标
主要结局
Change of mean of the "State Anxiety" score of the State Trait Inventory Anxiety
时间窗: Between the inclusion and the end of the third cycle of chemotherapy (maximum cycle of 21 days)
Change of mean of the "State Anxiety" score of the State Trait Inventory Anxiety at the end of the third cycle of chemotherapy compared to the pre-treatment score (inclusion)
次要结局
未报告次要终点