Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 8
- 主要终点
- assess and compare stress and life quality of patients participating to a clinical trial vs patients treated a standard way
研究概览
简要总结
This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way.
详细描述
This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way A case-control study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •patient with solid tumor or recurrent hematologic cancer, treated by chemotherapy or targeted therapy evaluated every 2 or 3 cycles; except for clinical trials associating non drug treatment (radiotherapy, surgery...)
- •subject to a 1st, 2nd or 3rd line of antitumor treatment
- •a phase 2 open labeled study,
- •a phase 2 or 3 blind randomised study,
- •a phase 2 or 3 open randomised study,
- •a standard treatment non participating to a clinical trial
- •male or female patients ≥ 18 years of age
- •karnovsky ≥ 70 % or WHO (Performance Status) ≤ 2
- •recovered from prior toxicities
- •social security covered
- •written informed consent given
排除标准
- •psychiatric disorders, receiving psychotropic treatment
- •physical or psychological issues
- •forbidden to be included in this study
研究组 & 干预措施
phase II non randomized study
phase II non randomized study, "Case" : 40 patients description of patients feeling by questionnaires :
- Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey
- understanding of the implications of participating in a clinical trial
干预措施: questionnaires (Other)
phase II non randomized study
phase II non randomized study, "Case" : 40 patients description of patients feeling by questionnaires :
- Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey
- understanding of the implications of participating in a clinical trial
干预措施: questionnaire (Other)
blind randomized phase II or III study
blind randomized phase II or III study: "control" : 40 patients description of patients feeling by questionnaires :
- Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey
- understanding of the implications of participating in a clinical trial
干预措施: questionnaires (Other)
blind randomized phase II or III study
blind randomized phase II or III study: "control" : 40 patients description of patients feeling by questionnaires :
- Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey
- understanding of the implications of participating in a clinical trial
干预措施: questionnaire (Other)
open randomized phase II or III study
open randomized phase II or III study : 40 patients description of patients feeling by questionnaires : Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey
-understanding of the implications of participating in a clinical trial
干预措施: questionnaires (Other)
open randomized phase II or III study
open randomized phase II or III study : 40 patients description of patients feeling by questionnaires : Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey
-understanding of the implications of participating in a clinical trial
干预措施: questionnaire (Other)
receiving standard treatment
receiving standard treatment : 120 patients description of patients feeling by questionnaires :
-understanding of the implications of participating in a clinical trial
干预措施: questionnaires (Other)
结局指标
主要结局
assess and compare stress and life quality of patients participating to a clinical trial vs patients treated a standard way
时间窗: 4 years
quality of life questionnaire (QLQ C30) Anxiety and depression questionnaire (HADS)
次要结局
- evaluate links between using adjustment therapy and emotional regulation, and emotional and psychological experience of patients facing one or another situation(4 years)
- measure and compare variation in time of psychological and emotional consequences during treatment(5 years)
- measure the level of knowledge on the implications of participating in a clinical trial (case)(5 years)