To determine outcomes in long-term surviving brain metastases patients (>=2 years after diagnosis of brain metastases) treated with immunotherapy or targeted therapy.
ID
Source
Brief title
Condition
- Metastases
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Neurocognitive functioning
- Instrumental activities of daily living
- Health-related quality of life
- Epilepsy
- Radiological abnormalities (cerebral abnormalities and treatment-induced
radiological abnormalities)
Secondary outcome
Sociodemographic information (i.e. age at study assessments, gender, level of
education, marital status and living arrangements, current or last profession)
and clinical information (Karnofsky Performance Status, date of diagnosis
primary cancer, relevant histological and molecular tumor information, sites of
metastases, date of diagnosis brain metastases, number and location of brain
metastases, previously received anti-tumor treatment and anti-tumor treatment
at assessment, corticosteroid and antiepileptic drug use, and comorbidity).
Background summary
While prolonged survival can be achieved for patients with brain metastases
from any stage IV solid primary cancer treated with newer treatments such as
immunotherapy and targeted therapy, information on the impact of these
treatments on different outcomes, including those relevant to patients such as
the level of functioning and well-being, is scarce.
Study objective
To determine outcomes in long-term surviving brain metastases patients (>=2
years after diagnosis of brain metastases) treated with immunotherapy or
targeted therapy.
Study design
This will be a multicenter cross-sectional study on the long-term outcomes of
brain metastases patients treated with immunotherapy or targeted therapy.
Study burden and risks
While prolonged survival can be achieved for patients with brain metastases
treated with newer treatments such as immunotherapy and targeted therapy,
information on the impact of these treatment on different outcomes, including
those relevant to patients such as the level of functioning and well-being, is
scarce. This study will provide information about the net clinical benefit of
certain treatment strategies for patients with brain metastases, which can be
used in clinical decision-making. Although the included patients will not
benefit from this knowledge themselves, the results are valuable for future
patients. The risk and burden of this study for the participating patients is
minimal, although filling in the questionnaires and undergoing the
neurocognitive tests may be perceived as tiresome for some patients.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- Any histologically confirmed stage IV solid primary cancer and radiologically
confirmed brain metastases;
- Adult patients: >=18 years of age;
- Treated with immunotherapy and/or targeted therapy (as monotherapy, combined
or in combination with other treatment modalities);
- Diagnosis of brain metastases >=2 years ago;
- Willing to provide written informed consent.
Exclusion criteria
- Patients without understanding of the Dutch language, hampering the
completion of questionnaires or undergoing neurocognitive testing;
- Patients with a poor physical condition or any psychiatric condition or
cognitive impairment, as determined by the treating physician, that will hamper
them to provide consent to research or undergo neurocognitive testing or
completion of the questionnaires.
Design
Recruitment
metc-ldd@lumc.nl
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 | NL81888.058.22 |