Clinical trial · Observational

Correlation Between Psychological Stress and Progression of Newly Oligodendroglioma Towards Secondary Glioma

Correlation Between Psychological Stress and Progression of Newly Oligodendroglioma Towards Secondary Glioma: A Longitudinal Study Based on Long-term Follow-up

NCT05536986CI-TRIAL-00061056not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

It is a single-center, prospective, observational, non-randomized study of newly diagnosed oligodendroglioma 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
Oligodendroglioma, Adult	Adult Oligodendroglioma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Stressors	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
Observation group of newly oligodendroglioma 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
1. Other: Stressors
label
Observation group of newly oligodendroglioma 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 oligodendroglioma 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)

Data not yet available

No reference posted for this study.