Brain Tumors
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBrain Training Program
BEHAVIORALBrain Health Program
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age 18 or older 2. fluent in English 3. able to provide informed consent to all procedures 4. diagnosis of a brain tumor 5. indication of lasting post-treatment cognitive deficits (e.g., from clinical presentation, prior neuropsychological assessment, and/or self-report) 6. sufficient motor and sensory functioning to complete study activities 7. availability to complete all study activities 8. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive composite score | baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training) | Summation of standardized change scores on neuropsychological tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in functional composite score | 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 | 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 | 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 |
Countries
Canada
Outcome results
None listed