Brain Tumors Clinical Trial
Official title:
Cognitive Intervention After a Brain Tumor
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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