Toronto BNB Pilot Study

Brain Metastases Clinical Trial

Official title:

Pilot Study of the Toronto Brief Neurocognitive Battery (BNB)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082587
• Other study ID #: OCREB 14-006
• Status: Completed
• Phase: N/A
• First received: March 6, 2014
• Last updated: February 7, 2017
• Start date: September 2014
• Est. completion date: February 2, 2017

Study information

• Verified date: February 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 2, 2017
• Est. primary completion date: February 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Neoplasm Metastasis

Locations

Country	Name	City	State
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Sunnybrook Hospital - Odette Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1.5 years
Primary	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.	1.5 years
Secondary	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)	1.5 years
Secondary	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.	1.5 years