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Completed

NCT Number: NCT02489071

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5S1W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

(1) comorbid neurological or psychiatric disorder or other medical condition suspected to influence cognition

Treatment and study plan

Brain Training Program

Behavioral

Brain Health Program

Behavioral

Primary outcomes

  1. Change in cognitive composite score

    Time frame: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)

    Summation of standardized change scores on neuropsychological tests

Secondary outcomes

  1. Change in functional composite score

    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

  2. Change in quality of life composite score

    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

  3. Change in caregiver quality of life composite score

    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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2015
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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