Mental Health and Suicidality in Glioblastoma Patients in Germany

Official title

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

Overview

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 test Medical 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

Primary outcome measures

• Suicidality [Time frame: in the last 4 weeks before participating in the study]

Secondary outcome measures (4)

• Depression [Time frame: in the last 2 weeks before participating in the study]
• Anxiety [Time frame: in the last 2 weeks before participating in the study]
• Health-related quality of life (HRQoL) [Time frame: in the last week before participating in the study]
• Social support [Time frame: at the time of participation in the study (current status queried)]

Eligibility criteria

Inclusion criteria

• Diagnosis of glioblastoma, IDH wild-type (CNS WHO classification of 2021)
• 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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 6 centers

• Charite — Berlin
• University Hospital Knappschaftskrankenhaus Bochum — Bochum
• University Hospital Essen — Essen
• University hospital Hamburg Eppendorf — Hamburg
• University hospital Heidelberg — Heidelberg
• University hospital Muenster — Münster

Publications

• 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 wit PMID 40931258
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07409584 · 25-12746-BO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗