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This study evaluates the feasibility and utility of two behavioural programs designed to reduce cognitive impairments secondary to brain tumors and/or their treatment. One-third of participants will complete training in either program, with the remaining third a wait-list control group.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain Training | Experimental | 8-session cognitive training program |
|
| Brain Health | Experimental | 8-session cognitive education program |
|
| Control | No Intervention | Wait-list control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Training Program | Behavioral |
| ||
| Brain Health Program |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive composite score | Summation of standardized change scores on neuropsychological tests | baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in functional composite score | Summation of standardized change scores on measures of occupational functioning | baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training) |
| Change in quality of life composite score |
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Inclusion Criteria:
Exclusion Criteria:
(1) comorbid neurological or psychiatric disorder or other medical condition suspected to influence cognition
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| Name | Affiliation | Role |
|---|---|---|
| Kim Edelstein, PhD | Princess Margaret Cancer Centre, University Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Toronto | Ontario | M5S1W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30847839 | Derived | Richard NM, Bernstein LJ, Mason WP, Laperriere N, Maurice C, Millar BA, Shultz DB, Berlin A, Edelstein K. Cognitive rehabilitation for executive dysfunction in brain tumor patients: a pilot randomized controlled trial. J Neurooncol. 2019 May;142(3):565-575. doi: 10.1007/s11060-019-03130-1. Epub 2019 Mar 7. |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
Summation of standardized change scores on measures of affect, perceived self-efficacy, and illness burden
| baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training) |
| Change in caregiver quality of life composite score | Summation of standardized change scores on measures of affect and caregiver burden | baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training) |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |