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Toronto BNB Pilot Study

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ClinicalTrials.gov Identifier: NCT02082587
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease
Brain Metastases

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Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of the Toronto Brief Neurocognitive Battery (BNB)
Study Start Date : September 2014
Actual Primary Completion Date : February 2, 2017
Actual Study Completion Date : February 2, 2017

Group/Cohort
QOL Assessment



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Evaluate the change in neurocognitive function before and after WBRT using the Toronto BNB [ Time Frame: 1.5 years ]
    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)

  2. Evaluate sensitivity to change (responsiveness) of the Toronto BNB (in clinic and by telephone) [ Time Frame: 1.5 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed brain metastases planned for whole brain radiotherapy
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082587


Locations
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Canada, Ontario
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y2P9
Sunnybrook Hospital - Odette Cancer Centre
Toronto, Ontario, Canada, M4N3M5
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Caroline Chung, MD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02082587    
Other Study ID Numbers: OCREB 14-006
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Keywords provided by University Health Network, Toronto:
brain metastases
brain mets
WBRT
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases