Mental Health and Suicidality in Glioblastoma Patients in Germany

NCT07409584 | Recruiting

• 1 other identifier: 25-12746-BO
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 6

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.

Conditions

Glioblastoma (GBM)

Keywords

glioblastoma; suicidality; depression; observational

Outcome Measures

Primary Outcomes (1)

• Suicidality

  Measured using a questionnaire

  in the last 4 weeks before participating in the study

Secondary Outcomes (4)

• Depression

  in the last 2 weeks before participating in the study

• Anxiety

  in the last 2 weeks before participating in the study

• Health-related quality of life (HRQoL)

  in the last week before participating in the study

• Social support

  at the time of participation in the study (current status queried)

Study Arms (1)

glioblastoma patients

primary disease or recurrence

Diagnostic Test: Medical history, physical examination, completing questionnaires, data collection

Interventions

Medical history, physical examination, completing questionnaires, data collection DIAGNOSTIC_TEST

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

glioblastoma patients

Eligibility Criteria

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

Study Population

glioblastoma patients

You may qualify if:

• Diagnosis of glioblastoma, IDH wild-type (CNS WHO classification of 2021)
• Age ≥ 18 years

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Hospital, Essen: lead
• University Hospital Muenster: collaborator
• Charite University, Berlin, Germany: collaborator
• University Hospital Heidelberg: collaborator
• Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (6)

Charite

Berlin, Germany

RECRUITING

University Hospital Knappschaftskrankenhaus Bochum

Bochum, Germany

NOT YET RECRUITING

University Hospital Essen

Essen, 45147, Germany

RECRUITING

University hospital Hamburg Eppendorf

Hamburg, Germany

RECRUITING

University hospital Heidelberg

Heidelberg, Germany

RECRUITING

University hospital Muenster

Münster, Germany

RECRUITING

Related Publications (10)

• Renovanz M, Hippler M, Kuchen R, Doerner L, Rieger D, Steinbach JP, Ronellenfitsch MW, Voss M, Kessler AF, Nickl V, Misch M, Onken JS, Rapp M, Nadji-Ohl M, Mehlitz M, Meixensberger J, Fehrenbach MK, Keric N, Ringel F, Coburger J, Lucas CW, Wehinger J, Schmidt-Graf F, Gempt J, Tatagiba M, Tabatabai G, Schranz M, Singer S. Physician-led versus questionnaire-based psychosocial screening in adults with high-grade glioma: a cluster-randomized controlled trial (GLIOPT). J Neurooncol. 2025 Dec;175(3):967-977. doi: 10.1007/s11060-025-05223-6. Epub 2025 Sep 10.

  PMID: 40931258 BACKGROUND

• Costanza A, Zenga F, Ruda R, Amerio A, Aguglia A, Serafini G, Amore M, Bondolfi G, Berardelli I, Nguyen KD. Suicidality in Patients with Brain Tumors: A Brief Literature Review with Clinical Exemplar. Medicina (Kaunas). 2020 Dec 21;56(12):725. doi: 10.3390/medicina56120725.

  PMID: 33371470 BACKGROUND

• Heinrich M, Hofmann L, Baurecht H, Kreuzer PM, Knuttel H, Leitzmann MF, Seliger C. Suicide risk and mortality among patients with cancer. Nat Med. 2022 Apr;28(4):852-859. doi: 10.1038/s41591-022-01745-y. Epub 2022 Mar 28.

  PMID: 35347279 BACKGROUND

• Zaorsky NG, Zhang Y, Tuanquin L, Bluethmann SM, Park HS, Chinchilli VM. Suicide among cancer patients. Nat Commun. 2019 Jan 14;10(1):207. doi: 10.1038/s41467-018-08170-1.

  PMID: 30643135 BACKGROUND

• Dong J, Chen Q, Weng S, Liu L, Wang J, Fang S, Fan X, Jiang T. The effect of depression and anxiety on survival in patients with glioma: a systematic review and meta-analysis. J Neurooncol. 2024 Nov;170(2):265-275. doi: 10.1007/s11060-024-04799-9. Epub 2024 Sep 3.

  PMID: 39225956 BACKGROUND

• Litofsky NS, Farace E, Anderson F Jr, Meyers CA, Huang W, Laws ER Jr; Glioma Outcomes Project Investigators. Depression in patients with high-grade glioma: results of the Glioma Outcomes Project. Neurosurgery. 2004 Feb;54(2):358-66; discussion 366-7. doi: 10.1227/01.neu.0000103450.94724.a2.

  PMID: 14744282 BACKGROUND

• Mugge L, Mansour TR, Crippen M, Alam Y, Schroeder J. Depression and glioblastoma, complicated concomitant diseases: a systemic review of published literature. Neurosurg Rev. 2020 Apr;43(2):497-511. doi: 10.1007/s10143-018-1017-2. Epub 2018 Aug 9.

  PMID: 30094499 BACKGROUND

• Finze A, Deleanu L, Weiss C, Ratliff M, Seiz-Rosenhagen M. Depression in brain tumor patients-early detection and screening. Support Care Cancer. 2023 May 16;31(6):339. doi: 10.1007/s00520-023-07785-5.

  PMID: 37191815 BACKGROUND

• Piil K, Jarden M, Jakobsen J, Christensen KB, Juhler M. A longitudinal, qualitative and quantitative exploration of daily life and need for rehabilitation among patients with high-grade gliomas and their caregivers. BMJ Open. 2013 Jul 11;3(7):e003183. doi: 10.1136/bmjopen-2013-003183. Print 2013.

  PMID: 23847270 BACKGROUND

• Goebel S, Stark AM, Kaup L, von Harscher M, Mehdorn HM. Distress in patients with newly diagnosed brain tumours. Psychooncology. 2011 Jun;20(6):623-30. doi: 10.1002/pon.1958. Epub 2011 Mar 30.

  PMID: 21449043 BACKGROUND

MeSH Terms

Conditions

Glioblastoma; Suicidal Ideation; Depression

Interventions

Physical Examination

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; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sied Kebir, PD Dr. med.

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Oster, Dr. med.

CONTACT

+49201-723-82598; christoph.oster@uk-essen.de

Mareike Rutenkröger, Dr. rer. medic.

CONTACT

+4940 7410-56863; M.Rutenkroeger@uke.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 13, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

DE (6)