To describe the cognitive, physical and psychosocial factors of fatigue which may affect fatigue in patients with glioma.
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To describe the physical, cognitive and psychosocial factors of fatigue which
can be of influence on the fatigue in patients with glioma. The nature of the
experienced fatigue will be described based on the results of the subscales of
the MFI. The physical status will be described based on a maximum test
(physical fitness) and based on the ambulatory movement registration (physical
activity). The cognitive status of the patient will be described based on the
neuropsychological examination distinguishing between the domains of attention,
memory and executive functioning. The psycho-social status of the patient will
be described on based on the results of the questionnaires, focusing on the
mood, sleep quality and quality of life.
Secondary outcome
nvt
Background summary
Gliomas are the most common primary brain tumors. They arise from the glial
tissue of the central nervous system and are classified and graded according to
the criteria of the World Health Organization. Low-grade gliomas have an
average incidence of 1 per 100.000 persons per year. The peak incidence is in
the young adult age, between 30 and 40 years old. The survival rate of patients
with LGG is increasing due to improved neurosurgical techniques, advanced
radiotherapy and chemotherapy. Median survival rates are currently between five
and fifteen years. Due to increased life expectancy, new issues in this patient
group arise including daily functioning and social participation.
In 2016 a new WHO classification was issued. This new WHO classification 2016,
had an important addition to the WHO classification of 2007, namely the use of
molecular parameters to determine tumor entities.
Survival of patients with glioma has increased over recent decades, through the
development of new and improved treatment options consisting of neurosurgery,
radiotherapeutic and chemotherapeutic interventions. Survival is currently
between five and fifteen years.
Recent scientific research shows that the difference in survival between Grade
II and Grade III IDH mutated tumors is less different than in the classical
histopathological classification. This is especially true for the grade 3
oligodendrogliomas with the molecular entity IDH mutant. The median survival
rate is 12-14 years, and thus comparable to the median survival of the LGG
tumors as described above.
Patients with glioma report various symptoms due to their disease and/or
treatment, such as fatigue, cognitive impairment and mood disorders. These
complaints may interfere with the level of functioning and social
participation.
Fatigue is the symptom with the greatest impact on quality of life and daily
functioning of patients and their relatives.
Cancer-related fatigue is defined as a persistent, (subjectively) sensation of
physical, emotional and/or cognitive fatigue or exhaustion related to cancer or
the treatment of cancer, which is disproportionate to recent activity and
interferes with normal daily functioning. The underlying pathophysiology and
mechanisms of this fatigue are so far unresolved. The aetiology of
cancer-related fatigue seems multifactorial. There is a lack of understanding
regarding the problems of cancer-related fatigue, which makes it difficult to
achieve adequate treatment.
It can be concluded that there is a lack of knowledge about the pathophysiology
of fatigue in patients with glioma. This research aims is focused on a better
understanding of the physical, cognitive and emotional factors of fatigue which
can affect the fatigue in patients with gliomas.
Study objective
To describe the cognitive, physical and psychosocial factors of fatigue which
may affect fatigue in patients with glioma.
Study design
The study design includes an observational cross-sectional study of patients
with glioma.
Study burden and risks
The total investment in time regarding of the patient is 135 minutes per
patient and consists of; the completion of the questionnaires, participating in
the neuropsychological examination, the execution of the maximal test and
receiving instructions with regard to the ambulatory movement registration.
During the 5-day ambulatory movement registration, the patient can perform all
daily activities. Therefore, no time investment expressed in minutes is
mentioned.
All patients will be assessed by the physician, before proceeding to the
execution of the maximal exercise test. In addition, an continuous ECG
monitoring takes place during the exercises. These actions minimalized the
risk of cardiac ischemia and/or arrhythmia at the time of the maximal exercise
time.
Filling in the questionnaires, the neuropsychological examination and undergo
the physical tests may be perceived as tiresome. To minimize any inconvenience,
it was decided that the questionnaires can be completed at home. Also the
neuropsychological research is conducted at home, taking into account the load
capacity. In addition, the physical tests are clustered in one day part. The
blood sampling may give a short-term pain sensation and may possibly give a
small bruise
Westersingel 300
Rotterdam 3001 KD
NL
Westersingel 300
Rotterdam 3001 KD
NL
Listed location countries
Age
Inclusion criteria
Patient population
Diagnosis: confirmed IDH mutated glioma II or III
Time: time post diagnosis >6 months * 5 years
Age: 18 years old or older
Exclusion criteria
Patient population
Treatment: patients receiving <3 months ago any form of cancer-related treatment like a surgical operation, radiotherapy and / or chemotherapy.
Diagnosis: patients with other progressive neurological disease(s and / or a psychiatric diagnosis according to the DSM IV
Diagnosis: patients with history of cardiopulmonary problems which constitute a contraindication for performing a ergometry (VO2max) test.
Language: insufficient comprehension of the Dutch language
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 | NL54616.078.15 |