The main research objective is to examine the influence of language impairments on social cognition (emotion recognition, Theory of Mind (ToM) and affective empathy), in patients with (suspected) gliomas. Secondary objectives are 1) to determine if…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are outcomes on measures for social cognition and
language.
Social cognition measures:
- The Ekman 60 faces test of the Facial Expressions of Emotion Stimuli and
Tests (emotion recognition)
- Cartoons test (ToM)
- Faux Past test (ToM, affective empathy).
Measures for language:
- letter and category fluency (verbal fluency, executive control)
- shortened version of the Boston Naming Test (visual confrontation naming)
- ScreeLing (screening of linguistic deficits)
- subtest of the Semantische Afasie Nederland (SAN) test (language
comprehension).
Secondary outcome
Patients
To assess spontaneous and general language, the following measurements will be
used:
* The Cookie Theft Picture Test
* Story telling (Fairy Tale and Christmas story)
* QuEST-NL
Patients and proxies
Three questionnaires will be used to examine social abilities and interaction:
* Interpersonal Reactivity Index (IRI) - empathy
* Dysexecutive Questionnaire (DEX) - difficulties in everyday situations
* Couples Satisfaction Index (CSI) - relationship satisfaction
Other study parameters:
Demographic data (including age, gender and education level) and information
regarding tumor characteristics (classification of tumor type, tumor location,
molecular mutations) will be obtained from the patient's medical reports.
Furthermore, general cognitive abilities will be measureds using the following
tests, allowing to control for severe cognitive impairment that may interfere
with the performance on tests for social cognition and language.
* Rivermead Behavioral Memory Test (RBMT) - verbal memory
* Rule Shift Cards Test - cognitive flexibility
Background summary
Patients with gliomas often suffer from lower quality of life, and detrimental
social interactions after diagnosis. Two cognitive processes are crucial for
maintaining healthy social relationships and interacting with others: social
cognition and language. Social cognition is the ability to recognize and
process mental and emotional states and to react appropriately in social
situations. Social cognition and language are separate cognitive functions that
can be affected in different ways in patients with brain injury. Also, distinct
cognitive measurement instruments are used to assess both processes. However,
there appears to be a certain overlap between social cognition and language.
Reacting adequately in social situations requires both verbal and non-verbal
communication and to communicate feelings, thoughts and intentions, people
often use language. That is, verbal communication is part of a symbolic system
that makes social interaction possible. Therefore, language abilities seem to
be important to social cognition.
Research shows that language is frequently impaired in adult patients with
gliomas. Importantly, recent evidence suggests that social cognition can also
be impaired in this patient group. However, no studies have been conducted into
the influence of language on social cognition in patients with gliomas.
Increasing knowledge on the influence of language difficulties on social
cognition, will improve diagnostic accuracy. Eventually, this will lead to
better, tailor-made treatments for these problems that negatively affect daily
functioning.
Study objective
The main research objective is to examine the influence of language impairments
on social cognition (emotion recognition, Theory of Mind (ToM) and affective
empathy), in patients with (suspected) gliomas.
Secondary objectives are
1) to determine if patients with gliomas show impairments in different aspects
of social cognition, i.e. emotion recognition, ToM, empathy and self-awareness;
2) to assess specific language impairments by looking at item-level
characteristics of language tasks (e.g., analyses of word properties of fluency
tasks, errors during object naming or spontaneous speech);
3) to determine which tumor characteristics (low- or high-grade, genetic
mutation, tumor location and volume) are associated with different aspects of
language and social cognition.
Study design
Cross-sectional study, data collected 1 to 3 weeks pre-operatively.
Study burden and risks
The proposed study is an observational study with no known health risks. At
present, a neuropsychological assessment (NPA) is already part of routine
clinical care for all patients with low-grade gliomas referred for surgery. For
these patients, a few tests (2 for social cognition and 3 for language) will be
added to this routine clinical NPA. Thus: only for the patients with high-grade
gliomas referred for surgery, the proposed tests will be an addition to routine
clinical care. The NPA will take a maximum of three hours. The NPA can
potentially be tiring for patients. However, patients will be able to take
breaks in between and an experienced neuropsychologist will supervise the NPA,
thus patients* energetic status and well-being will be carefully monitored. The
neuropsychologists on the department of Neurology/Neurosurgery, unit
Neuropsychology, have ample experience regarding NPA in patients with gliomas.
Overall, it can be concluded that the majority of patients are able to undergo
a NPA of maximum 3 hours, without adverse consequences. There are no direct
benefits for the individual patient from participation. Increasing knowledge
on the overlap between both functions and the relationship with certain tumor
characteristics, will improve diagnostic accuracy and eventually lead to
better, tailor-made treatments for language and behavioral problems that
negatively affect daily functioning.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
- Patient with suspected glioma, i.e. low- or high-grade gliomas.
- Age older than 18 years
- Sufficient command of the Dutch language
- Being able to understand the instructions of the neuropscyhological
assessment and to mentally and physically sustain/endure the assessment; this
will be assessed in a consultation between treating physician (neurosurgeon)
and investigator (neuropsychologist).
Exclusion criteria
- Serious neurodegenerative or psychiatric conditions (including addiction)
- Serious (other) medical conditions or physical inability hindering patients
to come to the hospital
- Patients who need to undergo emergency craniotomy
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 |
---|---|
ClinicalTrials.gov | NCT05764460 |
CCMO | NL83778.042.23 |