Clinical trial NCT05515133: Correlation Between Psychological Stress and Disease Progression in Newly Diagnosed Glioblastoma Patients
Official title: Correlation of Psychological Stress With Quality of Life and Efficacy of Immunotherapy Response in Patients With Newly Diagnosed Glioblastoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glioblastoma
Keywords: glioblastoma
psychological stress
Immune microenvironment
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: newly diagnosed glioblastoma

Brief summary: 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.

Detailed description: Glioblastoma (GBM) is the most common and aggressive primary malignant brain tumor affecting adults, with a median survival of 12-16 months after diagnosis. The diagnosis of a malignant tumor has a huge impact on patients' psychology, which is easy to lead to patients in a state of stress.

The high-stress level can lead to a change in patients' health behaviors and correlates with the prognosis outcome. In addition, psychological stress can lead to changes in the immune microenvironment, but disease progression and quality of life in glioblastoma have not been adequately demonstrated.

Grouping process: 60 patients are expected to be enrolled. After enrollment, participants will receive regular tumor in situ fluid (fluid within the surgical cavity, TISF) sampling for tumor mutation burden（TMB) analysis and recceive regular MRI. Under the standard of care, participants will receive psychological stress assessment after being diagnosed. according to five psychological scales, and the patients were grouped according to the cut-off value of each scale, the psychological stress of the patients is measured by distress thermometer (DT), perceived stress scale (PSS), anxiety/depression (HADS), VAS stress, and fear of disease progression scale（PoP-Q-SF).

Primary study objectives:

• To evaluate the changes in immune markers of acute and chronic psychological stress in patients with glioblastoma after diagnosis.

Secondary study objectives:

* To evaluate the quality of life of patients with different psychological stress levels.
* To evaluate the progression-free survival of patients with different psychological stress levels.

Exploratory objectives:

* To evaluate the effect of managing the patient's psychological stress on the patient's immune microenvironment.
* To evaluate the incidence of mental illness.
* To evaluate the patient treatment compliance.

Eligibility criteria: 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.

Primary outcomes:
measure: Tumor mutation burden（TMB）
timeFrame: From the time of diagnosis to 12 months
measure: The proportion of patients with high-level psychological stress
timeFrame: From the time of diagnosis to 12 months
Secondary outcomes:
measure: The Short Form-36 (SF-36)
timeFrame: From the time of diagnosis to 12 months
measure: Progression-free survival at 6 months
timeFrame: From the time of diagnosis to 12 months
Other outcomes:
measure: Overall survival rate at 12 months
timeFrame: From the time of diagnosis to 12 months
measure: Progression-free survival
timeFrame: Up to 3 years after diagnosis
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
Study officials:
affiliation: Henan Provincial People's Hospital
name: Xingyao Bu, MD
role: STUDY_DIRECTOR
affiliation: Henan Provincial People's Hospital
name: Jie Mei, MD
role: PRINCIPAL_INVESTIGATOR
References: