Brain MetastasesNCT02082587
Toronto BNB Pilot Study
An observational study of Brain Metastases, run by University Health Network, Toronto at 3 sites in Canada.
Trial summary
As treatments improve and patients live longer with cancer, even after it has spread to the brain, efforts to improve quality of life are growing. Neurocognitive function (thinking ability and memory) is an area of particular concern for patients with brain metastases (cancer that can spread to the brain). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- How many people
- 39 participants
- Where
- 3 sitesCanada
- Study dates
- Sep 2014to 2 Feb 2017
- 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: Patients with newly diagnosed brain metastases planned for whole brain radiotherapy
Who may be able to join
- Adult (> 18 years old) with newly diagnosed brain metastases planned for whole brain radiotherapy
- Performance status ECOG 0-2
- English-speaking (due to small sample-size in this pilot study, only English testing will be completed)
Who cannot join
- Prior whole brain radiotherapy
- Presence of any condition which can prevent completion of neurocognitive assessment, including:
- Hearing impairment which is sufficient to prevent the patient from comprehending English instructions in a quiet environment
- Major psychiatric diagnosis or neurological condition associated with cognitive impairment which, in the judgement of the investigator, would make the patient inappropriate for study participation (e.g., schizophrenia, multiple sclerosis, Parkinson's disease, prior ischemic stroke, dementia, traumatic brain injury with loss of consciousness for greater than 30 minutes, expressive/receptive aphasia, developmental delay)
- Patients with planned systemic therapy or additional radiotherapy within the interval between clinic and telephone Toronto BNB testing
- Minimal English skills such that subjects would be unable to follow simple English instructions (either verbal or written) or be unable to read questionnaires of a grade 8 standard with the help of a research assistant.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Southlake Regional Health Centre
Newmarket, Ontario, L3Y2P9
Sunnybrook Hospital - Odette Cancer Centre
Toronto, Ontario, M4N3M5
Princess Margaret Cancer Centre
Toronto, Ontario, M5G2M9
About this study
Official title: Pilot Study of the Toronto Brief Neurocognitive Battery (BNB)
As treatments improve and patients live longer with cancer, even after it has spread to the brain, efforts to improve quality of life are growing. Neurocognitive function (thinking ability and memory) is an area of particular concern for patients with brain metastases (cancer that can spread to the brain). Although there are established tests to measure neurocognitive function, these require a face-to-face assessment and can take a long time to complete. As a result, efforts to use these tests to measure changes in neurocognitive function in patients following treatment for brain metastases have resulted in a large proportion of patients who do not return for follow-up. This has limited the ability to evaluate the impact of current treatments on neurocognitive function. This study aims to evaluate a shorter, telephone-based neurocognitive assessment tool, which would make it easier for patients to complete these tests in follow-up. If this new tool is found to reliably measure neurocognitive function, it could be used for future studies evaluating new interventions that prevent or treat neurocognitive deterioration following treatment of brain metastases. This is the first prospective study to evaluate the feasibility and reliability of a novel telephone-based brief neurocognitive assessment battery (Toronto BNB) compared with the same battery delivered face-to-face in this population. The investigators hypothesize that telephone administration of this brief neurocognitive battery will reliably evaluate neurocognitive function and improve patient ability to complete follow-up assessments.
- Conditions
- Brain Metastases
- Keywords
- brain metastases, brain mets, WBRT
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| QOL Assessment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate feasibility of utilizing a telephone assessment in patients with brain metastases
The telephone-based tool will be considered feasible if the proportion of participants who complete baseline and follow-up telephone-based assessments is the same as or greater than the proportion of participants who complete the in-clinic assessments.
Measured: 1.5 years
Evaluate the interprocedure (telephone vs. clinic) reliability
Cronbach's alpha coefficient at each time point (baseline, 1 month, 4 months) will be calculated to assess the following z scores: Patient results from individual neurocognitive tests will be converted to a z score (the number of standard deviations above or below the mean). Overall averaged global z scores will be compared between the telephone and clinic assessments using the Toronto BNB. Cronbach's alpha coefficient will be evaluated as follows: 0-0.2 poor agreement; 0.3-0.4 fair agreement; 0.5-0.6 moderate agreement; 0.7-0.8 strong agreement; >0.8 very strong agreement.
Measured: 1.5 years
Secondary outcomes (2)
Evaluate the change in neurocognitive function before and after WBRT using the Toronto BNB
Paired t-tests will be used to assess whether any statistically significant change is observed between neurocognitive scores obtained at 1 month and 4 months after WBRT as compared to baseline (before WBRT)
Measured: 1.5 years
Evaluate sensitivity to change (responsiveness) of the Toronto BNB (in clinic and by telephone)
Paired t-tests will be used to assess whether any statistically significant change is observed between 1 month and 4 months using the BNB obtained in clinic and then using the BNB obtained over the phone.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startSep 2014
- Primary completion2 Feb 2017
- Study completion2 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Chung, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082587
- Sponsor's protocol ID
- OCREB 14-006
- Status last verified
- Feb 2017
- First submitted
- 6 Mar 2014
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Toronto Brief Neurocognitive Battery (BNB)
- ClinicalTrials.gov ID
- NCT02082587
- Acronym / sponsor ID
- OCREB 14-006
- Conditions
- Brain Metastases
- Keywords
- brain metastases, brain mets, WBRT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 2 Feb 2017 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 10 Mar 2014 (estimated)
- 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.
As treatments improve and patients live longer with cancer, even after it has spread to the brain, efforts to improve quality of life are growing. Neurocognitive function (thinking ability and memory) is an area of particular concern for patients with brain metastases (cancer that can spread to the brain). Although there are established tests to measure neurocognitive function, these require a face-to-face assessment and can take a long time to complete. As a result, efforts to use these tests to measure changes in neurocognitive function in patients following treatment for brain metastases have resulted in a large proportion of patients who do not return for follow-up. This has limited the ability to evaluate the impact of current treatments on neurocognitive function. This study aims to evaluate a shorter, telephone-based neurocognitive assessment tool, which would make it easier for patients to complete these tests in follow-up. If this new tool is found to reliably measure neurocognitive function, it could be used for future studies evaluating new interventions that prevent or treat neurocognitive deterioration following treatment of brain metastases. This is the first prospective study to evaluate the feasibility and reliability of a novel telephone-based brief neurocognitive assessment battery (Toronto BNB) compared with the same battery delivered face-to-face in this population. The investigators hypothesize that telephone administration of this brief neurocognitive battery will reliably evaluate neurocognitive function and improve patient ability to complete follow-up assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QOL Assessment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed brain metastases planned for whole brain radiotherapy
Key inclusion criteria (3 listed)
- Adult (> 18 years old) with newly diagnosed brain metastases planned for whole brain radiotherapy
- Performance status ECOG 0-2
- English-speaking (due to small sample-size in this pilot study, only English testing will be completed)
Key exclusion criteria (6 listed)
- Prior whole brain radiotherapy
- Presence of any condition which can prevent completion of neurocognitive assessment, including:
- Hearing impairment which is sufficient to prevent the patient from comprehending English instructions in a quiet environment
- Major psychiatric diagnosis or neurological condition associated with cognitive impairment which, in the judgement of the investigator, would make the patient inappropriate for study participation (e.g., schizophrenia, multiple sclerosis, Parkinson's disease, prior ischemic stroke, dementia, traumatic brain injury with loss of consciousness for greater than 30 minutes, expressive/receptive aphasia, developmental delay)
- Patients with planned systemic therapy or additional radiotherapy within the interval between clinic and telephone Toronto BNB testing
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
Evaluate feasibility of utilizing a telephone assessment in patients with brain metastases
Time frame: 1.5 years
The telephone-based tool will be considered feasible if the proportion of participants who complete baseline and follow-up telephone-based assessments is the same as or greater than the proportion of participants who complete the in-clinic assessments.
Evaluate the interprocedure (telephone vs. clinic) reliability
Time frame: 1.5 years
Cronbach's alpha coefficient at each time point (baseline, 1 month, 4 months) will be calculated to assess the following z scores: Patient results from individual neurocognitive tests will be converted to a z score (the number of standard deviations above or below the mean). Overall averaged global z scores will be compared between the telephone and clinic assessments using the Toronto BNB. Cronbach's alpha coefficient will be evaluated as follows: 0-0.2 poor agreement; 0.3-0.4 fair agreement; 0.5-0.6 moderate agreement; 0.7-0.8 strong agreement; >0.8 very strong agreement.
2 secondary outcomes
Evaluate the change in neurocognitive function before and after WBRT using the Toronto BNB
Time frame: 1.5 years
Evaluate sensitivity to change (responsiveness) of the Toronto BNB (in clinic and by telephone)
Time frame: 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
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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.
Caroline Chung, MD principal investigator
University Health Network, Toronto
3 sites 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, run by University Health Network, Toronto at 3 sites in Canada.
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 6 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: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate feasibility of utilizing a telephone assessment in patients with brain metastases (time frame: 1.5 years). The study lists 2 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 8 Feb 2017.