This study aims at determining to what extent brain tumor patients have limitations in social cognition, if these limitations are dependent on patient, tumor, or treatment characteristics, and how these limitations affect functioning of informal…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The extent to which social cognition, and more in specific, perception of
emotions, is affected in brain tumor patients.
Secondary outcome
Investigate possible determinants of compromised social cognition, including
cognitive functioning, tumor location, tumor grading, and interventions.
Determine the association between social cognition of the patients and mental
health of informal caregivers.
Background summary
Gliomas are the most common primary malignant brain tumors, with an incidence
of about six per 100,000. Despite efforts in improving the treatment of
gliomas, these tumors cannot be cured. Besides physical complaints, and
complaints of fatigue and depression, 80% of primary brain tumor patients have
cognitive deficits. Patients with inadequate awareness of these deficits may
adopt maladaptive responses to their social environment. A lack of
self-awareness can furthermore lead to perspective-taking difficulties that are
associated with impaired social cognition, which entails emotional processes
(perception of emotions, emotional empathy), and rational processes (*theory of
mind*, cognitive empathy, pragmatic inference). Nevertheless, self-awareness
has hardly been studied in brain tumor patients. For partners, these changes in
behavior and personality are often described as the most problematic
consequences of the disease, and the emotional distress in partners increases
as patients are less aware of these consequences. Considering the significant
overlap in the brain regions that are affected by brain tumors and/or their
treatment and the brain regions that are essential for social cognition, social
cognition is likely to be affected in these patients.
Study objective
This study aims at determining to what extent brain tumor patients have
limitations in social cognition, if these limitations are dependent on patient,
tumor, or treatment characteristics, and how these limitations affect
functioning of informal caregivers. Identification of brain regions involved in
social cognition can be used for optimizing safe brain tumor surgery and be
integrated in rehabilitation for patients with gliomas and their informal
caregivers.
Study design
The study will be designed as a cross-sectional study.
Study burden and risks
Assessment of functions and consequent failure on these assessments can be
confronting. Participants may always choose not to answer questions or perform
assessments that they are uncomfortable with. Furthermore there are no risks
but also no direct benefits for patients and their informal caregivers.
van der Boechorststraat 7
Amsterdam 1081BT
NL
van der Boechorststraat 7
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, patients must meet the following criteria:
1) Histological diagnosis of glioma, being astrocytoma, ¬oligodendroglio¬ma, oligoastrocytoma, or glioblas¬toma multiforme
2) Patients are not under active treatment with radiotherapy and/or chemotherapy
3) ><= 18 years of age
4) Written informed consent;In order to be eligible to participate in this study, informal caregivers must meet the following criteria:;1) ><= 18 years of age
2) Written informed consent
Exclusion criteria
1) Insufficient mastery of the Dutch language
2) Currently under active treatment for psychiatric disorders
3) Autism Spectrum Disorder or recurrent psychoses
4) Self-reported substance abuse
5) Major head trauma not related to the brain tumor or treatment
6) Neurodegenerative disorders
7) Severe visual impairments
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57198.029.16 |