The aim of the proposed project is to develop a user-friendly and standardized online neuropsychological test battery. It will be a concise test, measuring those domains which have proven to be most sensitive to the adverse effects of chemo- and…
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A subset of the participating patients (n=220) completes the following
traditional neuropsychological tests:
1) Visual reaction time (FePsy); 2) WAIS III Digit Span (forward & backward);
3) Corsi Block-tapping Test; 4) Trailmaking A and B (TMT); 5) Tower of London
(TOL); 6) Controlled Oral Word Association (COWA); 7) Rey Auditory Verbal
Learning test, short form; 8) Grooved Pegboard; 9) Japanese and caucasian brief
affect recognition test (JACBART).
Also, the newly developed neuropsychological test battery is conducted by all
patients (n=385) and healthy controls (n=330). This test consists of several
subtests based on the here above mentioned traditional tests.
Secondary outcome
- questionnaire on anxiety and depression: Hopkins Symptom Checklist-25
- demographics
- short questionnaire on internet usage
Background summary
In recent years there has been an increasing interest in cognitive dysfunction
after cancer treatment. Several neuropsychological studies demonstrated adverse
effects of chemo- and hormonal therapy in a subset of patients. A recent study
by our group indicated the occurrence of neurocognitive problems. Evidence came
from neuropsychological and neurophysiological research as well as from patient
self reports from up until 5 years after chemotherapy. Moreover, our animal
studies have shown a significant decrease in celproliferation in the rat
hippocampus after a single dose intervenous administration of methotrexaat.
Cognitive problems have a negative impact on the daily life of patients, can
limit possibilities for work and studies and thus affect quality of live.
Neuropsychological assessments offer objective measurements of functioning in
specific cognitive domains, and are important for 1) cancer research: to
evaluate treatments and to guide future directions; and 2) clinical patient
care: to assess the disease/treatment sequelae and to guide interventions.
Typical assessments are conducted by trained professionals in a face-to-face
setting, using paper and pencil or computerized tests, which make them
time-consuming and labor-intensive. Therefore, to date most studies conducted
are relatively small. As not all cancer patients and all cognitive domains seem
to be affected alike, and the trend in cancer treatment is towards more
personalized - and therefore less prevalent - treatment strategies, much larger
studies are needed to determine the relative cognitive toxicity of specific
treatments, and to identify subgroups of patients most vulnerable for cognitive
effects in a context of many confounding factors.
The past decade it has been shown that online assessment provides a good method
to obtain data in large samples in a quick and cost efficient way. An online
cognitive testing tool may help to rapidly acquire large data sets and could
therefore proof to be of importance for the research in the field of cancer and
cognition.
Study objective
The aim of the proposed project is to develop a user-friendly and standardized
online neuropsychological test battery. It will be a concise test, measuring
those domains which have proven to be most sensitive to the adverse effects of
chemo- and hormonal therapy. These domains are: learning and memory, attention,
executive functioning and information processing speed. For each domain 1 or 2
subtests will be selected.
Traditional neuropsychological tests with adequate psychometric qualities will
be used as a starting point and converted to online equivalents. The online
cognitive test battery is intended to be: 1) tailored to detect cognitive
dysfunction associated with cancer treatment; 2) designed to optimize test
performance (to get test results that show true capacity) in unmonitored
settings; 3) fully tested on usability, convergent validity, context validity,
and test-retest reliability; 4) sustained by customized reference data; and 5)
ready for deployment in larger-scale research on cancer and cognition.
Such a testing tool will allow us to signal side-effects of (new) therapies in
an early stage, monitor cognitive functioning pre- and post treatment and -
eventually- to identify patients at risk for developing cognitive problems.
Subsequently, the resulting knowledge can support oncologists in choosing
suitable therapies for their patients, cognitive researchers in designing
interventions against cognitive impairment in cancer patients, and patients in
optimizing their quality of life after cancer treatment.
Study design
This observational study is a collaboration between the department of
Psychosocial Research and Epidemiology of the NKI-AVL, the Psychonomics
department of the University of Amsterdam and the department of Communication
Science of the VU University Amsterdam.
Study burden and risks
There are no risks associated with participation in the study. The performance
of neuropsychological tests is generally considered as not too stressful.
Participants will be tested twice maximum. The assessments will take place at
the patient's home and/or in the Antoni van Leeuwenhoek hospital (depending on
the participant group they belong to). Travel expenses and parking costs will
be reimbursed.
Furthermore, since data is obtained though the internet, special attention will
be paid to safe data transmission and storage. Privacy is ensured by the use of
a secured MySQL database, encrypted data and a separate database for the
subjects' contact details including a unique code and excluding test results.
plesmanlaan 121
1066 CX Amsterdam
NL
plesmanlaan 121
1066 CX Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Disease free cancer patients (equal gender distribution, age-range: 18-74) treated at the NKI-AVL with chemotherapy and/or hormonal therapy will be included.
Healthy partners (partner, family member or friend of the opposite sex with comparable age and education level) of patients will serve as control group to gather reference data.
Patients and heatlhy controls should have sufficient proficiency in Dutch language.
Exclusion criteria
Cancer patients: involvement of the central nervous system
Healthy controls: cancer, any neurological or psychiatric symptoms which can influence cognitive performance
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 | NL37964.031.11 |