1) To collect information on patient characteristics, short and long-term clinical and patient reported outcomes and those of his/her caregiver. 2) To evaluate feasibility, performance and added value of new magnetic resonance imaging (MRI)…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical parameters (co-morbidity, oncological history, symptoms, imaging,
technical and treatment data), clinical endpoints (toxicity, reintervention and
survival) and patient reported outcomes.
Secondary outcome
Not applicable.
Background summary
The incidence of brain metastases is expected to increase because of better
treatments of primary tumours. Novel diagnostic and therapeutic techniques are
continuously being developed, all of which need thorough evaluation before they
can be implemented in clinical routine. Randomized Controlled Trials are the
gold standard to do so, but they have shown many challenges, especially when
applied in a cancer setting. The *cohort multiple Randomized Controlled Trial
(cmRCT)* design is a promising design for multiple (simultaneous) randomized
evaluations of experimental interventions, with potential for increased
recruitment, comparability and long-term outcomes as a standard. This design
will speed up the process of translating treatment innovations to the daily
clinic.
Study objective
1) To collect information on patient characteristics, short and long-term
clinical and patient reported outcomes and those of his/her caregiver.
2) To evaluate feasibility, performance and added value of new magnetic
resonance imaging (MRI) techniques.
3) To create an infrastructure for efficient, fast and pragmatic randomized
evaluation of new interventions.
Study design
Observational, prospective cohort study, according to the *cohort multiple
Randomized Controlled Trial* (cmRCT) design.
Study burden and risks
Patients will not experience direct benefit from participation in the COIMBRA
cohort. By participating, patients will contribute to the evidence on clinical
and environmental factors associated with treatment outcome, quality of life
(QoL) and survival. This will lead to better and a more personalized cancer
care for future patients. When not participating in RCT's, patients will
receive the regular optimal clinical care. Risks associated with participating
in the COIMBRA cohort study are negligible since it is an observational study.
Filling out the questionnaires, and the extra time in the MRI-scanner are the
only potential burden for the patients participating in this cohort. It will
take approximately 20-35 minutes to fill out the questionnaires each time. It
takes approximately 10 minutes for the caregiver to complete the questionnaire
each time. Finally, performing the NCA lasts, three times 90 minutes
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years;
- Either radiographic and/or histologic proof of metastatic brain disease, or
eligible for prophylactic cranial irradiation;
- Referred to the Department of Radiotherapy for cranial irradiation.
Exclusion criteria
- Mental disorder or cognitive dysfunction that hinder the patient*s ability to
understand the informed consent procedure and/or study details;
- Patients with severe psychiatric disorders;
- Inability to understand 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 | NL67206.041.18 |