Clinical trial NCT05267158: The Cohort for Patient-reported Outcomes, Imaging and Trial Inclusion in Metastatic BRAin Disease (COIMBRA)
Official title: The Cohort for Patient-reported Outcomes, Imaging and Trial Inclusion in Metastatic BRAin Disease (COIMBRA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Metastases, Adult
Brain Neoplasms, Adult, Malignant
Keywords: radiotherapy (RT)
QoL,Quality of life
Neurocognition
Brain metastases
Cranial irradiation
Neoplasm metastasis
Prognosis
Survival
Prospective
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are referred to the Department of Radiotherapy for treatment of brain metastases or for prophylactic cranial irradiation (PCI) will be asked to participate in this cohort study.

Brief 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.

Detailed description: The COIMBRA cohort is a prospective cohort, which will serve as a facility for efficient, systematic and simultaneous evaluation of new interventions and MRI sequences and prospective outcome studies (including prediction modelling).

COIMBRA patients will be followed prospectively and information on survival, symptoms, QoL (patient and caregiver), cognition, toxicity and daily functioning in relation to treatment will be collected prospectively.

Patients will receive the regular optimal clinical care according to the current guidelines when not participating in cmRCT's.

Eligibility criteria: 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.

Primary outcomes:
measure: Survival
timeFrame: Through study completion, an average of 1 year
measure: Time and Type of re-intervention
timeFrame: Through study completion, an average of 1 year
measure: Change in toxicity after radiotherapy
timeFrame: Through study completion, an average of 1 year
measure: Technical and treatment data
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Change in patient reported outcomes; general quality of life
timeFrame: Through study completion, an average of 1 year
measure: Change in patient reported outcomes; cancer related fatigue
timeFrame: Through study completion, an average of 1 year
measure: Change in patient reported outcomes; depression and anxiety
timeFrame: Through study completion, an average of 1 year
measure: Change in patient reported outcomes; disease-specific symptoms of brain metastases and (adverse) effects of their treatment
timeFrame: Through study completion, an average of 1 year
measure: Change in caregiver reported outcomes: general quality of life
timeFrame: Through study completion, an average of 1 year
measure: Change in caregiver reported outcomes: depression and anxiety
timeFrame: Through study completion, an average of 1 year
measure: Change in the caregiver burden
timeFrame: Through study completion, an average of 1 year
measure: Patients coping and personality
timeFrame: Baseline
measure: Caregiver coping and personality
timeFrame: Baseline
measure: Neurocognitive functioning
timeFrame: We are testing this twice: once before radiotherapy and 3 months after radiotherapy
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Joost JC Verhoeff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: