Clinical trial · Observational
Correlation Between Psychological Stress and Progression of Diffuse Astrocytoma Towards Secondary Glioma
Correlation Between Psychological Stress and Progression of Diffuse Astrocytoma Towards Secondary Glioma: a Longitudinal Study Based on Long-term Follow-up
- 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 diffuse astrocytoma patients conducted in a tertiary hospital. The investigators conduct an eight-year follow-up, including patients' psychological stress, immune biomarker changes, quality of life, and disease progression of patients towards secondary glioma after the first definite diagnosis. In the first year after diagnosis, patients are followed up four times at 1 month, 3 months, 6 months, and 12 months. After that, patients are followed up semiannually. 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 |
|---|---|---|---|
| Astrocytoma | Astrocytoma | 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 diffuse astrocytoma patients with high-level psychological stress
- description
- The patients had high threshold levels of perceived psychological stress, fear, anxiety, and depression as assessed by psychologists
- interventionNames
- Other: stressors
- label
- Observation group of newly diffuse astrocytoma 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 (3)
- measure
- The proportion of patients with tumor recurrence
- timeFrame
- From the time of diagnosis to 8 years
- description
- The proportion of patients with diffuse astroglioma who had recurrence after tumor resection.
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 glioma * 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)
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