Brain Metastases, AdultCOIMBRANCT05267158
The Cohort for Patient-reported Outcomes, Imaging and Trial Inclusion in Metastatic BRAin Disease (COIMBRA)
An observational study of Brain Metastases, Adult and Brain Neoplasms, Adult, Malignant, run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Adult, Brain Neoplasms, Adult, Malignant
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Apr 2019to 1 May 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, 3508GA
Joost JC Verhoeff, MD, PhD, +31-88-7564393, j.j.c.verhoeff-10@umcutrecht.nl
Fia F Cialdella, MD, +31631118339, f.cialdella@umcutrecht.nl
About this study
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.
Read the 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.
- Keywords
- radiotherapy (RT), QoL,Quality of life, Neurocognition, Brain metastases, Cranial irradiation, Neoplasm metastasis, Prognosis, Survival, Prospective
- Medical subject headings
- Brain Neoplasms, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival of participating patients will be recorded using the follow up questionnaires (returned by family members) or are derived from the Municipal Personal Records Database (in Dutch: Basisregistratie Personen (BRP))
Measured: Through study completion, an average of 1 year
Time and Type of re-intervention
Re-intervention (re-irradiation, surgery, other); Development of neurological symptoms; Development of new metastases.
Measured: Through study completion, an average of 1 year
Change in toxicity after radiotherapy
The toxicity will be reported by using the serious adverse event (SAE) questionnaire, every 6 months
Measured: Through study completion, an average of 1 year
Technical and treatment data
Dose, fractions and technique of radiotherapy. All other planned and/or received treatment for brain metastases and primary tumour (i.e. systemic therapy, surgery, radiotherapy), and the characteristics there of (type, dose, duration, awake surgery, extent of surgery, complications)
- Use of epileptic drugs, including type and dose
Measured: Through study completion, an average of 1 year
Secondary outcomes (10)
Change in patient reported outcomes; general quality of life
General quality of life will be reported by the questionnaires named C30 and EQ-5D. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is the instrument most frequently used to measure quality of life in cancer patients, whereas the EQ-5D is widely used to measure and evaluate general health status.
Baseline, at 1 month, 3 months, and every subsequent 3 months, after initial radiotherapy is completed. Both the total score of the questionnaires and the individual questions are used in which we look at the difference between the measurement moments.
Measured: Through study completion, an average of 1 year
Change in patient reported outcomes; cancer related fatigue
Cancer related fatigue is measured by using the MFI-20 questionnaire. The MFI-20 is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue. The instrument was used in a Dutch and Scottish sample of cancer patients receiving radiotherapy
Baseline, at 1 month, 3 months, and every subsequent 3 months, after initial radiotherapy is completed. Both the total score of the questionnaires and the individual questions are used in which we look at the difference between the measurement moments.
Measured: Through study completion, an average of 1 year
Change in patient reported outcomes; depression and anxiety
Cancer related depression and anxiety is reported by the HADS. The Hospital Anxiety and Depression Scale (HADS) is a self-assessment questionnaire that has been found to be a reliable instrument for detecting states of anxiety and depression in the setting of hospital outpatient clinic. The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
Baseline, at 1 month, 3 months, and every subsequent 3 months, after initial radiotherapy is completed. Both the total score of the questionnaire and the individual questions are used in which we look at the difference between the measurement moments.
Measured: Through study completion, an average of 1 year
Change in patient reported outcomes; disease-specific symptoms of brain metastases and (adverse) effects of their treatment
Disease-specific symptoms of brain metastases and (adverse) effects of their treatment are measured by a combination of questionnaires: BN20 and CFQ. The BN20 scoring transforms 20 questions into 11 scales to assess neurological deficits (visual disorder, motor dysfunction, communication deficit), future uncertainty, and disease- and treatment-related symptoms.
The Cognitive Failures Questionnaire (CFQ) is used in ergonomics research to measure behavioural problems associated with attentiveness and memory in everyday life.
Baseline, at 1 month, 3 months, and every subsequent 3 months, after initial radiotherapy is completed.Both the total scores of each neurological deficit and cognitive failure and the individual questions are used in which we look at the difference between the measurement moments.
Measured: Through study completion, an average of 1 year
Change in caregiver reported outcomes: general quality of life
General quality of life will be reported by the questionnaire EQ-5D. The EQ-5D is widely used to measure and evaluate general health status.
Baseline, at 1 month, 3 months, and every subsequent 3 months, after initial radiotherapy of the patient is completed. Both the total score of the questionnaire and the individual questions are used in which we look at the difference between the measurement moments.
Measured: Through study completion, an average of 1 year
Change in caregiver reported outcomes: depression and anxiety
Depression and anxiety is reported by the HADS. The Hospital Anxiety and Depression Scale (HADS) is a self-assessment questionnaire that has been found to be a reliable instrument for detecting states of anxiety and depression in the setting of hospital outpatient clinic. The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
Baseline, at 1 month, 3 months, and every subsequent 3 months, after initial radiotherapy of the patient is completed. Both the total score of the questionnaire and the individual questions are used in which we look at the difference between the measurement moments.
Measured: Through study completion, an average of 1 year
Change in the caregiver burden
The Caregiver Strain Index (CSI) is a tool that can be used to quickly identify families with potential caregiving concerns. It is a 13-question tool that measures strain related to care provision. There is at least one item for each of the following major domains: Employment, Financial, Physical, Social and Time. Positive responses to seven or more items on the index indicate a greater level of strain. This instrument can be used to assess individuals of any age who have assumed the role of caregiver for an older adult.
Baseline, at 1 month, 3 months, and every subsequent 3 months, after initial radiotherapy of the patient is completed. Both the total score of the questionnaire and the individual questions are used in which we look at the difference between the measurement moments.
Measured: Through study completion, an average of 1 year
Patients coping and personality
Patients are asked to fill out the Utrechtse Coping Lijst (UCL) and the NEO Five-Factor Inventory (NEO-FFI)
Measured: Baseline
Caregiver coping and personality
Caregivers are asked to fill out the Utrechtse Coping Lijst (UCL) and the NEO Five-Factor Inventory (NEO-FFI)
Measured: Baseline
Neurocognitive functioning
The neuro cognitive assessment (NCA) tests that focus on the specific cognitive domains that are most sensitive to the effects of brain irradiation are used for measuring the neurocognitive functioning.
The following domains are tested: general cognitive functioning, memory, language, executive functioning, attention, psychomotor speed, fine motor coordination, visuoconstruction, visuoperception, and social cognition. The test battery takes a maximum of 90 minutes to administer and is based upon international standards
Measured: We are testing this twice: once before radiotherapy and 3 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start26 Apr 2019
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastases, AdultStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joost J.C. Verhoeff, UMC Utrecht
- Investigators
- Joost JC Verhoeff, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267158
- Sponsor's protocol ID
- NL67206.041.18
- Acronym
- COIMBRA
- Status last verified
- Aug 2022
- First submitted
- 17 Sep 2021
- Last updated
- 6 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cohort for Patient-reported Outcomes, Imaging and Trial Inclusion in Metastatic BRAin Disease (COIMBRA)
- ClinicalTrials.gov ID
- NCT05267158
- Acronym / sponsor ID
- COIMBRA / NL67206.041.18
- Keywords
- radiotherapy (RT), QoL,Quality of life, Neurocognition, Brain metastases, Cranial irradiation, Neoplasm metastasis, Prognosis, Survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: Through study completion, an average of 1 year
Survival of participating patients will be recorded using the follow up questionnaires (returned by family members) or are derived from the Municipal Personal Records Database (in Dutch: Basisregistratie Personen (BRP))
Time and Type of re-intervention
Time frame: Through study completion, an average of 1 year
Re-intervention (re-irradiation, surgery, other); Development of neurological symptoms; Development of new metastases.
Change in toxicity after radiotherapy
Time frame: Through study completion, an average of 1 year
The toxicity will be reported by using the serious adverse event (SAE) questionnaire, every 6 months
Technical and treatment data
Time frame: Through study completion, an average of 1 year
Dose, fractions and technique of radiotherapy. All other planned and/or received treatment for brain metastases and primary tumour (i.e. systemic therapy, surgery, radiotherapy), and the characteristics there of (type, dose, duration, awake surgery, extent of surgery, complications) - Use of epileptic drugs, including type and dose
10 secondary outcomes
Change in patient reported outcomes; general quality of life
Time frame: Through study completion, an average of 1 year
Change in patient reported outcomes; cancer related fatigue
Time frame: Through study completion, an average of 1 year
Change in patient reported outcomes; depression and anxiety
Time frame: Through study completion, an average of 1 year
Change in patient reported outcomes; disease-specific symptoms of brain metastases and (adverse) effects of their treatment
Time frame: Through study completion, an average of 1 year
Change in caregiver reported outcomes: general quality of life
Time frame: Through study completion, an average of 1 year
Change in caregiver reported outcomes: depression and anxiety
Time frame: Through study completion, an average of 1 year
Change in the caregiver burden
Time frame: Through study completion, an average of 1 year
Patients coping and personality
Time frame: Baseline
Caregiver coping and personality
Time frame: Baseline
Neurocognitive functioning
Time frame: We are testing this twice: once before radiotherapy and 3 months after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Coimbra Cohort (in Dutch)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joost JC Verhoeff, MD, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastases, Adult and Brain Neoplasms, Adult, Malignant, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joost JC Verhoeff, MD, PhD (+31-88-7564393, j.j.c.verhoeff-10@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.