Cognitive Intervention After a Brain Tumor
- Conditions
- Brain Tumors
- Interventions
- Behavioral: Brain Health ProgramBehavioral: Brain Training Program
- Registration Number
- NCT02489071
- Lead Sponsor
- University Health Network, Toronto
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- 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
(1) comorbid neurological or psychiatric disorder or other medical condition suspected to influence cognition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brain Health Brain Health Program 8-session cognitive education program Brain Training Brain Training Program 8-session cognitive training program
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada