Cognitive Intervention After a Brain Tumor
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 16, 2015
CompletedFirst Posted
Study publicly available on registry
July 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedSeptember 27, 2018
September 1, 2018
4 years
June 16, 2015
September 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in cognitive composite score
Summation of standardized change scores on neuropsychological tests
baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Secondary Outcomes (3)
Change in functional composite score
baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Change in quality of life composite score
baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Change in caregiver quality of life composite score
baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Study Arms (3)
Brain Training
EXPERIMENTAL8-session cognitive training program
Brain Health
EXPERIMENTAL8-session cognitive education program
Control
NO INTERVENTIONWait-list control group
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- (1) comorbid neurological or psychiatric disorder or other medical condition suspected to influence cognition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Princess Margaret Cancer Centre
Toronto, Ontario, M5S1W8, Canada
Related Publications (1)
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.
PMID: 30847839DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kim Edelstein, PhD
Princess Margaret Cancer Centre, University Health Network
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2015
First Posted
July 2, 2015
Study Start
August 1, 2014
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
September 27, 2018
Record last verified: 2018-09