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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.
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.
Secondary study objectives:
Exploratory objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation group of newly diagnosed glioblastoma patients with high-level psychological stress | The patients had high threshold levels of perceived stress, psychological distress, fear, anxiety, and depression as assessed by psychologists |
| |
| Observation group of newly diagnosed glioblastoma patients with low-level psychological stress | The patients had lower than threshold levels of perceived stress, psychological distress, fear, anxiety, and depression as assessed by psychologists |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stressors | Other | Patients are exposed to stressful situations related to the diagnosis and treatment of the disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor mutation burden(TMB) | The proportion of tumor mutational burden ≥10 Mut/MB in the population who remain progression-free after diagnosis. | From the time of diagnosis to 12 months |
| The proportion of patients with high-level psychological stress | 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. | From the time of diagnosis to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Short Form-36 (SF-36) | The questionnaire of Short Form-36 (SF-36) is used health-related quality-of-life measure in participants outcomes. The scale contains 9 dimensions with a total score of 100 points. | From the time of diagnosis to 12 months |
| Progression-free survival at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate at 12 months | OS-12 is the proportion of participants in the analysis population who remain alive for at least twelve months after diagnosis. | From the time of diagnosis to 12 months |
| Progression-free survival |
Inclusion Criteria:
Exclusion Criteria:
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newly diagnosed glioblastoma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingyao Bu, PhD | Contact | +86037165580295 | xingyaobu@zzu.edu.cn | |
| Jie Mei, MD | Contact | +8615188318262 | meijie@zzu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xingyao Bu, MD | Henan Provincial People's Hospital | Study Director |
| Jie Mei, MD | Henan Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial People's Hospital | Zhengzhou | Henan | 450003 | China |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D000087602 | Anthropogenic Effects |
| ID | Term |
|---|---|
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
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The proportion of participants in the analysis population who remain progression-free for at least six months after diagnosis. |
| From the time of diagnosis to 12 months |
Median time from allocation to first documented disease progression as per RANO or death due to any cause, whichever occurs first.
| Up to 3 years after diagnosis |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |