Precoce Medical Care by the Mobil Support for Patients With Glioblastoma Receiving Specific Medical Oncology Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Assess the feasibility in terms of compliance with early medical care in glioblastoma patients by palliative care unit.
研究概览
简要总结
Most patients with glioblastoma have impaired cognitive function, autonomy, and quality of life.
This clinical situation, combined with a limited life expectancy, makes the preservation of quality of life a major objective, in a supportive environment that respects family integration. This is especially true since there is an established relationship between health-related quality of life, as measured by questionnaires.
In this context, and despite the lack of impact on overall survival, improving quality of life becomes a priority objective in recent Phase III trials.
The feasibility of introducing early accompaniment in GBM should be assessed in the diagnostic and therapeutic announcement environment. In order to measure the expected impact as favorable in the patient and his family, a broad survey of the classic domains of quality of life and more specifically dedicated to neurological symptomatology.
详细描述
glioblastomas are the most common primary malignant tumours of the central nervous system.They represent about 2000 new cases per year in France.
Despite active treatments including surgery, radiotherapy and chemotherapy, patient survival is limited without possible cure.
Most patients with glioblastoma have impaired cognitive function, autonomy, and quality of life. Exploration of verbal memory in these patients shows that its deterioration is correlated with a more unfavourable prognosis, after adjustment with other usual prognostic factors.
This clinical situation, combined with a limited life expectancy, makes the preservation of quality of life a major objective, in a supportive environment that respects family integration. This is especially true since there is an established relationship between health-related quality of life, as measured by questionnaires.
The feasibility of introducing early accompaniment in GBM should be assessed in the diagnostic and therapeutic announcement environment. In order to measure the expected impact as favorable in the patient and his family, a broad survey of the classic domains of quality of life and more specifically dedicated to neurological symptomatology.
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
- •Adult patient ( ≥ 18 years),
- •Histological diagnosis of Glioblastoma
- •Oncology caret at ICM (regardless of treatment: Stupp protocol, chemotherapy alone, targeted therapy, etc.);
- •Patient consent signed after informed information.
排除标准
- •Patient unable to consent to the study
- •Major impairment of the general health : performance status OMS =4;
- •Patient not affiliated with a French social security
结局指标
主要结局
Assess the feasibility in terms of compliance with early medical care in glioblastoma patients by palliative care unit.
时间窗: from date of inclusion visit until an average of 3 months
Compliance is defined as the proportion of patients attending three palliative care unit visits (Ve1, Ve2 and Ve3).
次要结局
- Proportion of patients completing all anxiety assessments (HADS, Hospital Anxiety and Depression Scale) at palliative care unit visits (Ve1, Ve2 and Ve3)(from date of inclusion visit until an average of 3 months)
- Proportion of patients completing all BN20 assessments (Brain Cancer Module) at palliative care unit visits (Ve1, Ve2 and Ve3)(from date of inclusion visit until an average of 3 months)
- Proportion of patients completing all quality of life assessments (QLQ-C30 (Quality Life Questionnaire) at palliative care unit visits (Ve1, Ve2 and Ve3)(from date of inclusion visit until an average of 3 months)
- The evolution over time of anxiety and depressive affects in patients(from date of inclusion visit until an average of 3 months)
- The evolution over time of neurocognitive performance in patients and the delay before neurocognitive degradation (Mattis DRS scale);(from date of inclusion visit until an average of 3 months)
- The proportion of patients diagnosed with glioblastoma that are available for this medical care(at the inclusion visit)
- Rate of patients who have designated a support person since the diagnostic announcement(From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- The recruitment rate (proportion of patients giving consent to participate in the study among eligible patients during screening)(at the inclusion visit)
- Overall survival(From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- Rate of patients who have written advance directives since the diagnostic announcement;(From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- proportion of patients receiving specific medical oncology treatment in their last month of life(From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- Changes over time in patients' quality of life(from date of inclusion visit until an average of 3 months)