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Mental Health and Suicidality in Glioblastoma Patients in Germany

Mental Health and Suicidality in Glioblastoma Patients in Germany - a Multicenter Observational Study (SHINE-GLIO Study)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07409584
Acronym
SHINE-GLIO
Enrollment
180
Registered
2026-02-13
Start date
2026-03-18
Completion date
2028-12-01
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma (GBM)

Keywords

glioblastoma, suicidality, depression, observational

Brief summary

The aim of the study is to use standardized questionnaires to systematically record influencing factors or predictors for suicidal behavior in glioblastoma patients, particularly with regard to existing depression and anxiety symptoms.

Detailed description

Treatment will be provided in accordance with guidelines as part of the study. If a patient decides to participate in the study and have given consent, he/she will undergo a study visit. In addition to a consultation with a physician ("medical history"), this includes a physical examination and the completion of questionnaires (Patient Health Questionnaire-8 to assess depression, Generalized Anxiety Disorder-7 to assess anxiety, Scale of Suicidal Experiences and Behavior to assess suicidality, EORTC-QLQ-30, and EORTC-QLQ BN-20 to assess health-related quality of life, and a short questionnaire on social support for chronic illnesses). If a need for psycho-oncological treatment is identified during the consultation (or during the examination itself) or expressed by the patient, a referral to the relevant specialist department will be arranged (if this has not already been done). Patient data used in the study is taken from the medical record (master data, diagnosis, therapy, MRIs, etc.) and from the study visit.

Interventions

DIAGNOSTIC_TESTMedical history, physical examination, completing questionnaires, data collection

Medical history Physical examination Completion of validated questionnaires: * Suicide Scale (SSEV) * Patient Health Questionnaire-8 (PHQ-8) * Generalized Anxiety Disorder-7 (GAD-7) * EORTC-QLQ-30 * EORTC-QLQ-BN-20 * Short questionnaire on social support for chronic illnesses (SUCE-4) Data collection from medical records

Sponsors

University Hospital, Essen
Lead SponsorOTHER
University Hospital Muenster
CollaboratorOTHER
Charite University, Berlin, Germany
CollaboratorOTHER
University Hospital Heidelberg
CollaboratorOTHER
Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany
CollaboratorUNKNOWN
Universitätsklinikum Hamburg-Eppendorf
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Newly diagnosed glioblastoma, IDH wild-type (CNS WHO classification of 2021) after finishing radiotherapy (before first recurrence) * Age ≥ 18 years

Exclusion criteria

* Participants with clinically significant aphasia or language barrier as assessed by the investigator * History of other malignant tumors * Known tumor predisposition syndrome (e.g., Li-Fraumeni syndrome, Cowden syndrome, etc.) * Recurrent glioblastoma

Design outcomes

Primary

MeasureTime frameDescription
Suicidalityin the last 4 weeks before participating in the studyMeasured using a questionnaire

Secondary

MeasureTime frameDescription
Depressionin the last 2 weeks before participating in the studyMeasured using a questionnaire
Anxietyin the last 2 weeks before participating in the studyMeasured using a questionnaire
Health-related quality of life (HRQoL)in the last week before participating in the studyMeasured using a questionnaire
Social supportat the time of participation in the study (current status queried)Measured using a questionnaire

Countries

Germany

Contacts

CONTACTChristoph Oster, Dr. med.
christoph.oster@uk-essen.de+49201-723-82598
CONTACTMareike Rutenkröger, Dr. rer. medic.
M.Rutenkroeger@uke.de+4940 7410-56863
PRINCIPAL_INVESTIGATORSied Kebir, PD Dr. med.

University Hospital, Essen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026