Correlation Between Psychological Stress and Progression of Diffuse Astrocytoma Towards Secondary Glioma
1 other identifier
observational
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2022
CompletedFirst Posted
Study publicly available on registry
September 8, 2022
CompletedStudy Start
First participant enrolled
December 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2026
ExpectedSeptember 27, 2022
September 1, 2022
3 years
September 5, 2022
September 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The proportion of patients with tumor recurrence
The proportion of patients with diffuse astroglioma who had recurrence after tumor resection.
From the time of diagnosis to 8 years
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 8 years
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 8 years
Secondary Outcomes (4)
The Short Form-36 (SF-36)
From the time of diagnosis to 8 years
Progression-free survival at 5 years
From the time of diagnosis to 8 years
Overall survival rate at 8 years
From the time of diagnosis to 8 years
Progression-free survival at 8 years
From the time of diagnosis to 8 years
Other Outcomes (1)
Classification proportion of glioma recurrence
From the time of diagnosis to 8 years
Study Arms (2)
Observation group of newly diffuse astrocytoma patients with high-level psychological stress
The patients had high threshold levels of perceived psychological stress, fear, anxiety, and depression as assessed by psychologists
Observation group of newly diffuse astrocytoma 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
Interventions
Patients are exposed to stressful situations related to the diagnosis and treatment of the disease
Eligibility Criteria
Adult patients with diffuse astroglioma
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xingyao Bu
Henan Provincial People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2022
First Posted
September 8, 2022
Study Start
December 20, 2022
Primary Completion
December 20, 2025
Study Completion (Estimated)
December 20, 2026
Last Updated
September 27, 2022
Record last verified: 2022-09