GlioblastomaNCT05515133
Correlation Between Psychological Stress and Disease Progression in Newly Diagnosed Glioblastoma Patients
An observational study of Glioblastoma, run by Henan Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- stressors
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: newly diagnosed glioblastoma
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Xingyao Bu, xingyaob@zzu.edu.cn
About this study
Official title: Correlation of Psychological Stress With Quality of Life and Efficacy of Immunotherapy Response in Patients With Newly Diagnosed Glioblastoma
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.
Read the 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.
- Conditions
- Glioblastoma
- Being tested
- stressors
- Keywords
- glioblastoma, psychological stress, Immune microenvironment
- Medical subject headings
- Glioblastoma, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stressorsOther
Patients are exposed to stressful situations related to the diagnosis and treatment of the disease
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor mutation burden（TMB）
The proportion of tumor mutational burden ≥10 Mut/MB in the population who remain progression-free after diagnosis.
Measured: 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.
Measured: From the time of diagnosis to 12 months
Secondary outcomes (2)
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.
Measured: From the time of diagnosis to 12 months
Progression-free survival at 6 months
The proportion of participants in the analysis population who remain progression-free for at least six months after diagnosis.
Measured: From the time of diagnosis to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start15 Dec 2022 (estimated)
- Primary completion15 Aug 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xingyao Bu, MD, Study director, Henan Provincial People's HospitalJie Mei, MD, Principal investigator, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515133
- Sponsor's protocol ID
- HenanPPH-Glioma
- Status last verified
- Aug 2022
- First submitted
- 21 Aug 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Psychological Stress With Quality of Life and Efficacy of Immunotherapy Response in Patients With Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT05515133
- Acronym / sponsor ID
- HenanPPH-Glioma
- Conditions
- Glioblastoma
- Keywords
- glioblastoma, psychological stress, Immune microenvironment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation group of newly diagnosed glioblastoma patients with high-level psychological stress | – | Other: stressorsThe 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- newly diagnosed glioblastoma
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stressorsPatients are exposed to stressful situations related to the diagnosis and treatment of the disease | Other | Observation group of newly diagnosed glioblastoma patients with high-level psychological stress |
Primary outcome
Tumor mutation burden（TMB）
Time frame: From the time of diagnosis to 12 months
The proportion of tumor mutational burden ≥10 Mut/MB in the population who remain progression-free after diagnosis.
The proportion of patients with high-level psychological stress
Time frame: From the time of diagnosis to 12 months
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.
2 secondary outcomes
The Short Form-36 (SF-36)
Time frame: From the time of diagnosis to 12 months
Progression-free survival at 6 months
Time frame: From the time of diagnosis to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Glioblastoma
RecruitingObservational study
Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
Glioblastoma Multiforme
Active, not recruitingPhase 3
Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
Glioblastoma, Recurrent Glioblastoma
RecruitingPhase 1
Anti-GD2 ADC M3554 in Advanced Solid Tumors
Advanced Solid Tumor
Active, not recruitingPhase 1
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
RecruitingPhase 2
Tamoxifen Versus Etoposide After First Recurrence in GBM Patients
Glioblastoma Multiforme
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xingyao Bu, MD study director
Henan Provincial People's Hospital
Jie Mei, MD principal investigator
Henan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by Henan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xingyao Bu, PhD (+86037165580295, xingyaobu@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor mutation burden（TMB） (time frame: From the time of diagnosis to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.