Clinical trial NCT02082587: Toronto BNB Pilot Study
Official title: Pilot Study of the Toronto Brief Neurocognitive Battery (BNB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Metastases
Keywords: brain metastases
brain mets
WBRT
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 39
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: Patients with newly diagnosed brain metastases planned for whole brain radiotherapy

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Evaluate feasibility of utilizing a telephone assessment in patients with brain metastases
timeFrame: 1.5 years
measure: Evaluate the interprocedure (telephone vs. clinic) reliability
timeFrame: 1.5 years
Secondary outcomes:
measure: Evaluate the change in neurocognitive function before and after WBRT using the Toronto BNB
timeFrame: 1.5 years
measure: Evaluate sensitivity to change (responsiveness) of the Toronto BNB (in clinic and by telephone)
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Hospital - Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Caroline Chung, MD
role: PRINCIPAL_INVESTIGATOR
References: