Psychological distress and Quality of life in patients with untreated meningiomas

• Conditions: D32.0; Cerebral meninges

• Registration Number: DRKS00016904
• Lead Sponsor: niversitätsmedizin der Johannes Gutenberg-Universität Mainz

Brief Summary

The level of psychological distress in asymptomatic meningiomas and postoperative meningiomas with excellent outcome is high.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-26
• Study Completion: 2020-07-07
• Results First Posted: 2020-11-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 62

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.

Secondary Outcome Measures

Name	Time	Method
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.<br>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.