Correlation Between Psychological Stress and Progression of Diffuse Astrocytoma Towards Secondary Glioma

ConditionAstrocytoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorHenan Provincial People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age ≥18 years

Karnofsky Performance Score ≥ 70 %

histologically confirmed, previously untreated glioma

receiving a standardized chemoradiotherapy regimen

Disqualifiers

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.

Trial population

Adult patients with diffuse astroglioma

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • stressors

    Other intervention

    Patients are exposed to stressful situations related to the diagnosis and treatment of the disease

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Observation group of newly diffuse astrocytoma patients with high-level psychological stress1 intervention
Group B: Observation group of newly diffuse astrocytoma patients with low-level psychological stress0 interventions

Trial outcomes

Primary outcomes

1

The proportion of patients with tumor recurrence

The proportion of patients with diffuse astroglioma who had recurrence after tumor resection.

Time frame
From the time of diagnosis to 8 years
2

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.

Time frame
From the time of diagnosis to 8 years
3

Tumor mutation burden (TMB)

The proportion of tumor mutational burden ≥10 Mut/MB in the population who remain progression-free after diagnosis.

Time frame
From the time of diagnosis to 8 years

Secondary outcomes

1

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.

Time frame
From the time of diagnosis to 8 years
2

Progression-free survival at 5 years

The proportion of participants in the analysis population who remain progression-free for at least 5 years after diagnosis.

Time frame
From the time of diagnosis to 8 years
3

Overall survival rate at 8 years

OS-36 is the proportion of participants in the analysis population who remain alive for at least 8 years after diagnosis.

Time frame
From the time of diagnosis to 8 years
4

Progression-free survival at 8 years

The proportion of participants in the analysis population who remain progression-free for at least 8 years after diagnosis.

Time frame
From the time of diagnosis to 8 years

Other outcomes

1

Classification proportion of glioma recurrence

Patients with recurrent gliomas undergo secondary surgery/needle biopsy to determine the type of recurrent glioma.

Time frame
From the time of diagnosis to 8 years

Sponsors and contacts

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