Psychological distress and Quality of life in patients with untreated meningiomas

Psychological distress and Quality of life in patients with untreated meningiomas - BLU-Men

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00016904

Enrollment

Registered

2019-03-26

Start date

2018-12-14

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

D32.0

Interventions

Group 1: Patients with meningiomas in Observation. The patients in both study Groups will be asked to assess their Quality of life and psychological distress. We will unvestigate the psychological dis

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age >18; legal capacity; consent capacity; untreated meningioma; radiological diagnosis of a meningioma; for a control group: patients with operated histologically confirmed meningioma; informed consent for the participation in the study; Patient is regularly followed up in a neurosurgical outpatient department

Exclusion criteria

Exclusion criteria: Meningiom-associated organic symptoms; focal neurological deficits, except for mild headache (1-2/10 according to VAS), postoperative scalp hypesthesia, paresis of the ramus frontalis of facial nerve; large mass effect of midline shift; no informed consent given

Design outcomes

Primary

Measure	Time frame
The number of patients with significant distress (anxiety/depression) (HADS=11 and/or DT=6) and the mean or median of these scores in patients with clinically observed meningiomas. The outcome will be evalued after the second assessment of the last study patient. The evaluation for individual study patients will be done on the regular Basis after each self-assessment. A psychoonkological intervention will be offered for the patients.	—

Measure

Time frame

The number of patients with significant distress (anxiety/depression) (HADS=11 and/or DT=6) and the mean or median of these scores in patients with clinically observed meningiomas. The outcome will be evalued after the second assessment of the last study patient. The evaluation for individual study patients will be done on the regular Basis after each self-assessment. A psychoonkological intervention will be offered for the patients.

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Secondary

Measure	Time frame
Differences in HADS (Hospital Anxiety and Depression Scale), DT, Brief fatigue inventory scores between the patients with observed and surgically treated meningiomas as well as general Population (historic data). Differences in HRQoL (Health-related quality of life) according to SF-36 between patients with observed and surgically treated meningiomas. The outcome will be evalued after the second assessment of the last study patient. The evaluation for individual study patients will be done on the regular Basis after each self-assessment. A psychooncological intervention will be offered for the patients.	—

Measure

Time frame

Differences in HADS (Hospital Anxiety and Depression Scale), DT, Brief fatigue inventory scores between the patients with observed and surgically treated meningiomas as well as general Population (historic data). Differences in HRQoL (Health-related quality of life) according to SF-36 between patients with observed and surgically treated meningiomas. The outcome will be evalued after the second assessment of the last study patient. The evaluation for individual study patients will be done on the regular Basis after each self-assessment. A psychooncological intervention will be offered for the patients.

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Countries

Germany

Contacts

Public ContactDarius Kalasauskas

Klinik und Poliklinik für Neurochirurgie

Darius.Kalasauskas@unimedizin-mainz.de+49 6131 17 7331

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026