To determine the effect of SRT on cognition and on quality of life of patients with one to 3 brain metastases, and to relate these outcome measures with radiological changes detected on MR imaging.
ID
Source
Brief title
Condition
- Metastases
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Indicators of cognitive functioning, fatigue, quality of life and radiological
features will be assessed as primary outcomes at baseline (before SRT), one
month after completion of SRT, and again three months and six months after
completion of SRT.
Secondary outcome
Neurological functioning and self care (in daily life)
Background summary
Currently, stereotactic radiotherapy (SRT) is one of the most used treatments
for brain metastases. In comparison to WBRT and neurosurgery, the application
of SRT is often less intensive and SRT is thought to be less harmful for
healthy brain tissue. Therefore, fewer side effects would occur and also the
effects on cognition, fatigue and quality of life should be less devastating
than after WBRT. However, it is not yet known to what extent SRT might
influence cognitive functioning and quality of life in patients treated with
SRT for brain metastases. In addition, it is not known how possible
radiological changes (e.g. tumour recurrence or the occurrence of
radionecrosis) relate to cognitive and quality of life outcomes in these
patients.
Study objective
To determine the effect of SRT on cognition and on quality of life of patients
with one to 3 brain metastases, and to relate these outcome measures with
radiological changes detected on MR imaging.
Study design
A prospective trial will be undertaken to monitor cognitive performance,
experienced quality of life and amount of fatigue, radiological features and
functional status at different points in time, in patients with one to three
newly diagnosed brain metastases who will be treated with SRT.
Study burden and risks
Only patients with brain metastases can participate in this study because of
the research question. For the participating patients, the burden associated
with participation consists of (1) completing a neuropsychological test battery
and (2) completing questionnaires regarding fatigue and quality of life, at
different visits to the hospital and at different points in time during the
follow up period. Possible benefits of participation for the patients consists
of (1) more frequent and better monitoring of possible cognitive dysfunction,
complaints of fatigue, impaired quality of life and radiological outcomes,
which could result in earlier and more individualised psychosocial education,
other interventions or referrals to other medical disciplines.
Lijnbaan 32
2501 VA Den Haag
Nederland
Lijnbaan 32
2501 VA Den Haag
Nederland
Listed location countries
Age
Inclusion criteria
1. Patient with * 3 newly diagnosed brain metastases,
2. Adult (* 18 years),
3. Patient will be treated with SRT,
4. Written informed consent.
Exclusion criteria
1. Patient has had any treatment (i.e. surgery, biopsy, WBRT and/or SRT) for his brain metastatic disease,
2. Patient will be treated with both WBRT and a SRT boost,
3. Patient has insufficient mastery of the Dutch language,
4. patient has other neurological or psychiatric conditions which could interfere with the results,
5. according to the treating physician, patient is (expected to be) unable to participate in the follow up period, because of serious physical or mental conditions (i.e. a KPS score below 70),
Design
Recruitment
metc-ldd@lumc.nl
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 | NL25305.098.08 |