Correlation of Psychological Stress With Quality of Life and Efficacy of Immunotherapy Response in Patients With Newly Diagnosed Glioblastoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tumor mutation burden（TMB）
研究概览
简要总结
It is a single-center, prospective, observational，non-randomized study of newly diagnosed glioblastoma patients conducted in a tertiary hospital. The investigators examine the psychological stress, immune biomarker changes, quality of life, and disease progression of patients with glioblastoma at five-time points.
The study had two cohorts, a high-stress cohort and a low-stress cohort, which are grouped after initial recruitment. Both groups undergo total resection of tumors and received 3 months of standardized treatment with radiotherapy and chemotherapy. Neither participants nor doctors but the researcher can choose which group participants are in. No one knows if one study group is better or worse than the other.
详细描述
Glioblastoma (GBM) is the most common and aggressive primary malignant brain tumor affecting adults, with a median survival of 12-16 months after diagnosis. The diagnosis of a malignant tumor has a huge impact on patients' psychology, which is easy to lead to patients in a state of stress.
The high-stress level can lead to a change in patients' health behaviors and correlates with the prognosis outcome. In addition, psychological stress can lead to changes in the immune microenvironment, but disease progression and quality of life in glioblastoma have not been adequately demonstrated.
Grouping process: 60 patients are expected to be enrolled. After enrollment, participants will receive regular tumor in situ fluid (fluid within the surgical cavity, TISF) sampling for tumor mutation burden（TMB) analysis and recceive regular MRI. Under the standard of care, participants will receive psychological stress assessment after being diagnosed. according to five psychological scales, and the patients were grouped according to the cut-off value of each scale, the psychological stress of the patients is measured by distress thermometer (DT), perceived stress scale (PSS), anxiety/depression (HADS), VAS stress, and fear of disease progression scale（PoP-Q-SF).
Primary study objectives:
• To evaluate the changes in immune markers of acute and chronic psychological stress in patients with glioblastoma after diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years
- •Karnofsky Performance Score ≥ 70 %
- •histologically confirmed, previously untreated GBM
- •receiving a standardized chemoradiotherapy regimen
- •no previous history of mental illness, drug abuse, or alcohol abuse
- •ability to communicate and read and write independently
- •willing and able to comply with the protocol as judged by the investigator's signed informed consent.
排除标准
- •Patients who have any other disease, either metabolic or psychological, or who have any evidence on clinical examination or special investigations (including laboratory findings) which give reasonable suspicion of a condition that interferes with the adequate measurement of the stress axis (e.g. chronic use of corticosteroids ≥ 3 months before study entry for diseases other than glioblastoma, (dexamethasone use in the context of glioblastoma is allowed) Severe, medically treated psychiatric disorder prior to the diagnosis of glioblastoma Participation in a study with investigational drugs.
- •pregnancy or breast-feeding
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurologic deficits that interfere with the planned walking tests, dementia, or confusional state.
结局指标
主要结局
Tumor mutation burden（TMB）
时间窗: From the time of diagnosis to 12 months
The proportion of tumor mutational burden ≥10 Mut/MB in the population who remain progression-free after diagnosis.
The proportion of patients with high-level psychological stress
时间窗: From the time of diagnosis to 12 months
The self-report questionnaire of Perceived Stress Scale（PSS）is used to measure the psychological stress level of patients, with 43 as the critical value, more than or equal to 43 as the high level of psychological stress, less than 43 as the low level of psychological stress.
次要结局
- The Short Form-36 (SF-36)(From the time of diagnosis to 12 months)
- Progression-free survival at 6 months(From the time of diagnosis to 12 months)