Cognitive Intervention After a Brain Tumor

Brain Tumors Clinical Trial

Official title:

Cognitive Intervention After a Brain Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489071
• Other study ID #: 13-7277-CE
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: August 2018

Study information

• Verified date: September 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors

Intervention

Behavioral:
• Brain Training Program

• Brain Health Program

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in functional composite score	Summation of standardized change scores on measures of occupational functioning	baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Secondary	Change in quality of life composite score	Summation of standardized change scores on measures of affect, perceived self-efficacy, and illness burden	baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
Secondary	Change in caregiver quality of life composite score	Summation of standardized change scores on measures of affect and caregiver burden	baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)