Princess Margaret Cancer Centre
Toronto, Ontario, M5S1W8, Canada
NCT Number: NCT02489071
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5S1W8, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(1) comorbid neurological or psychiatric disorder or other medical condition suspected to influence cognition
Time frame: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Summation of standardized change scores on neuropsychological tests
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
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
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
University Health Network, Toronto
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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