Cognitive Intervention After a Brain Tumor
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ClinicalTrials.gov Identifier: NCT02489071 |
Recruitment Status :
Completed
First Posted : July 2, 2015
Last Update Posted : September 27, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Tumors | Behavioral: Brain Training Program Behavioral: Brain Health Program | Not Applicable |
Cognitive impairments (including problems with attention, memory or executive functions) are common in people with brain tumors, as a result of the disease and/or treatment effects. These deficits, even when relatively mild, can interfere with interpersonal relationships, occupational activities, functional independence, and quality of life. They may also contribute to caregiver burden.
Building on research in other cognitively-impaired populations, in this study we compare two behavioural interventions. The Brain Training (BT) and Brain Health (BH) interventions each offer a structured yet client-centered program through 8 weekly individual treatment sessions and between-session exercises. Contents include mindfulness practice, strategy training, and supportive psychoeducation including counseling around lifestyle factors to promote brain functioning.
Using a prospective randomized controlled design, 54 brain tumor patients are being enrolled in one of three study arms: BT, BH, or standard care (wait-list control). A battery of outcome measures is being administered (1) prior to intervention, (2) after the 8-week behavioural intervention (or wait-list) period, and (3) after an additional 4 months to evaluate longer-term outcomes. Analyses of variance will examine treatment effects, with regression analyses to explore moderating effects of participant demographics, severity of baseline cognitive impairment, and tumor and treatment factors (e.g., tumor location, radiation dose and distribution). Results of this trial will lay the groundwork for implementation of evidence-based supportive care to reduce and manage cognitive impairments following a brain tumor.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Cognitive Intervention After a Brain Tumor |
Study Start Date : | August 2014 |
Actual Primary Completion Date : | August 2018 |
Actual Study Completion Date : | August 2018 |

Arm | Intervention/treatment |
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Experimental: Brain Training
8-session cognitive training program
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Behavioral: Brain Training Program |
Experimental: Brain Health
8-session cognitive education program
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Behavioral: Brain Health Program |
No Intervention: Control
Wait-list control group
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- Change in cognitive composite score [ Time Frame: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training) ]Summation of standardized change scores on neuropsychological tests
- Change in functional composite score [ Time Frame: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training) ]Summation of standardized change scores on measures of occupational functioning
- Change in quality of life composite score [ Time Frame: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training) ]Summation of standardized change scores on measures of affect, perceived self-efficacy, and illness burden
- Change in caregiver quality of life composite score [ Time Frame: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training) ]Summation of standardized change scores on measures of affect and caregiver burden

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age 18 or older
- fluent in English
- able to provide informed consent to all procedures
- diagnosis of a brain tumor
- indication of lasting post-treatment cognitive deficits (e.g., from clinical presentation, prior neuropsychological assessment, and/or self-report)
- sufficient motor and sensory functioning to complete study activities
- availability to complete all study activities
- for patients treated with cranial radiation, at least 3 months post-radiation
Exclusion Criteria:
(1) comorbid neurological or psychiatric disorder or other medical condition suspected to influence cognition

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): NCT02489071
Canada, Ontario | |
Princess Margaret Cancer Centre | |
Toronto, Ontario, Canada, M5S1W8 |
Principal Investigator: | Kim Edelstein, PhD | Princess Margaret Cancer Centre, University Health Network |
Responsible Party: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT02489071 |
Other Study ID Numbers: |
13-7277-CE |
First Posted: | July 2, 2015 Key Record Dates |
Last Update Posted: | September 27, 2018 |
Last Verified: | September 2018 |
Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |