Clinical trial NCT02489071: Cognitive Intervention After a Brain Tumor
Official title: Cognitive Intervention After a Brain Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumors
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in cognitive composite score
timeFrame: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Secondary outcomes:
measure: Change in functional composite score
timeFrame: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
measure: Change in quality of life composite score
timeFrame: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
measure: Change in caregiver quality of life composite score
timeFrame: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre, University Health Network
name: Kim Edelstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.