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Cognitive Intervention After a Brain Tumor

University Health Network, Toronto logo

University Health Network, Toronto

Status

Completed

Conditions

Brain Tumors

Treatments

Behavioral: Brain Health Program
Behavioral: Brain Training Program

Study type

Interventional

Funder types

Other

Identifiers

NCT02489071
13-7277-CE

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

26 participants in 3 patient groups

Brain Training
Experimental group
Description:
8-session cognitive training program
Treatment:
Behavioral: Brain Training Program
Brain Health
Experimental group
Description:
8-session cognitive education program
Treatment:
Behavioral: Brain Health Program
Control
No Intervention group
Description:
Wait-list control group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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