Cognitive Intervention After a Brain Tumor
Primary Purpose
Brain Tumors
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Brain Training Program
Brain Health Program
Sponsored by
About this trial
This is an interventional supportive care trial for Brain Tumors
Eligibility Criteria
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
Sites / Locations
- Princess Margaret Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Brain Training
Brain Health
Control
Arm Description
8-session cognitive training program
8-session cognitive education program
Wait-list control group
Outcomes
Primary Outcome Measures
Change in cognitive composite score
Summation of standardized change scores on neuropsychological tests
Secondary Outcome Measures
Change in functional composite score
Summation of standardized change scores on measures of occupational functioning
Change in quality of life composite score
Summation of standardized change scores on measures of affect, perceived self-efficacy, and illness burden
Change in caregiver quality of life composite score
Summation of standardized change scores on measures of affect and caregiver burden
Full Information
NCT ID
NCT02489071
First Posted
June 16, 2015
Last Updated
September 25, 2018
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02489071
Brief Title
Cognitive Intervention After a Brain Tumor
Official Title
Cognitive Intervention After a Brain Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brain Training
Arm Type
Experimental
Arm Description
8-session cognitive training program
Arm Title
Brain Health
Arm Type
Experimental
Arm Description
8-session cognitive education program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Wait-list control group
Intervention Type
Behavioral
Intervention Name(s)
Brain Training Program
Intervention Type
Behavioral
Intervention Name(s)
Brain Health Program
Primary Outcome Measure Information:
Title
Change in cognitive composite score
Description
Summation of standardized change scores on neuropsychological tests
Time Frame
baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Secondary Outcome Measure Information:
Title
Change in functional composite score
Description
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)
Title
Change in quality of life composite score
Description
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)
Title
Change in caregiver quality of life composite score
Description
Summation of standardized change scores on measures of affect and caregiver burden
Time Frame
baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Edelstein, PhD
Organizational Affiliation
Princess Margaret Cancer Centre, University Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S1W8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
30847839
Citation
Richard NM, Bernstein LJ, Mason WP, Laperriere N, Maurice C, Millar BA, Shultz DB, Berlin A, Edelstein K. Cognitive rehabilitation for executive dysfunction in brain tumor patients: a pilot randomized controlled trial. J Neurooncol. 2019 May;142(3):565-575. doi: 10.1007/s11060-019-03130-1. Epub 2019 Mar 7.
Results Reference
derived
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Cognitive Intervention After a Brain Tumor
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