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Cognitive Intervention After a Brain Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02489071
Recruitment Status : Completed
First Posted : July 2, 2015
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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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.

Condition or disease Intervention/treatment Phase
Brain Tumors Behavioral: Brain Training Program Behavioral: Brain Health Program Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Cognitive Intervention After a Brain Tumor
Study Start Date : August 2014
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arms and Interventions
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Arm Intervention/treatment
Experimental: Brain Training
8-session cognitive training program
 Behavioral: Brain Training Program
Experimental: Brain Health
8-session cognitive education program
 Behavioral: Brain Health Program
No Intervention: Control
Wait-list control group


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489071


Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5S1W8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Kim Edelstein, PhD Princess Margaret Cancer Centre, University Health Network
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02489071    
Other Study ID Numbers: 13-7277-CE
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases