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

NCT05515133 | Unknown

• 1 other identifier: HenanPPH-Glioma
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Keywords

glioblastoma; psychological stress; Immune microenvironment

Outcome Measures

Primary Outcomes (2)

• 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 12 months

• 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 12 months

Secondary Outcomes (2)

• The Short Form-36 (SF-36)

  From the time of diagnosis to 12 months

• Progression-free survival at 6 months

  From the time of diagnosis to 12 months

Other Outcomes (2)

• Overall survival rate at 12 months

  From the time of diagnosis to 12 months

• Progression-free survival

  Up to 3 years after diagnosis

Study Arms (2)

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

Other: stressors

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

stressors OTHER

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

newly diagnosed glioblastoma

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

MeSH Terms

Conditions

Glioblastoma; Stress, Psychological

Interventions

Anthropogenic Effects

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Ecological and Environmental Phenomena; Biological Phenomena

Study Officials

• Xingyao Bu, MD

  Henan Provincial People's Hospital

  STUDY DIRECTOR

• Jie Mei, MD

  Henan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingyao Bu, PhD

CONTACT

+86037165580295; xingyaobu@zzu.edu.cn

Jie Mei, MD

CONTACT

+8615188318262; meijie@zzu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: August 25, 2022
• Study Start: December 15, 2022
• Primary Completion: August 15, 2024
• Study Completion: December 31, 2025
• Last Updated: September 27, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)