Correlation Between Psychological Stress and Disease Progression in Newly Diagnosed Glioblastoma Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05515133
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Henan Provincial People's Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Xingyao Bu, MDJie Mei, MD
Principal Investigator Affiliation	Henan Provincial People's HospitalHenan Provincial People's Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Additional Details

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.

Arms & Interventions

Arms

: Observation group of newly diagnosed glioblastoma patients with high-level psychological stress

The patients had high threshold levels of perceived stress, psychological distress, fear, anxiety, and depression as assessed by psychologists

: Observation group of newly diagnosed glioblastoma 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

Other: - stressors

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Henan Provincial People's Hospital, Zhengzhou, Henan, China

Status

Address

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003

Site Contact

Xingyao Bu

[email protected]

+86037165580295

Clinical Trial Finder