Clinical trial · Observational
Correlation Between Psychological Stress and Disease Progression in Newly Diagnosed Glioblastoma Patients
Correlation of Psychological Stress With Quality of Life and Efficacy of Immunotherapy Response in Patients With Newly Diagnosed Glioblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stressors | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Observation group of newly diagnosed glioblastoma patients with high-level psychological stress
- description
- The patients had high threshold levels of perceived stress, psychological distress, fear, anxiety, and depression as assessed by psychologists
- interventionNames
- Other: stressors
- label
- Observation group of newly diagnosed glioblastoma patients with low-level psychological stress
- description
- The patients had lower than threshold levels of perceived stress, psychological distress, fear, anxiety, and depression as assessed by psychologists
Primary outcomes (2)
- measure
- Tumor mutation burden（TMB）
- timeFrame
- From the time of diagnosis to 12 months
- description
- The proportion of tumor mutational burden ≥10 Mut/MB in the population who remain progression-free after diagnosis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available