Clinical trial NCT03537911: Cognitive Support Program for Patients With Brain Metastases
Official title: Cognitive Support Program for Patients With Brain Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastases, CNS
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the feasibility and preliminary efficacy of a brief cognitive-behavioural program designed to improve cognitive functioning in people with brain metastases.

Detailed description: Cognitive impairments (such as problems with attention, executive functions, memory and language abilities) are common in people with brain metastases as a result of disease and/or treatment effects. These impairments can significantly limit functional independence, participation in valued roles and activities, and overall quality of life.

Building on research in other cognitively-impaired populations, we designed a brief, structured, patient-centered Cognitive Support Program (CSP) for brain metastases patients, who have the option of participating with a caregiver. Program contents include supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration). This prospective, single-arm study will enroll 24 brain metastases patients to evaluate the feasibility and preliminary efficacy of the CSP. A battery of outcome measures is administered (1) prior to intervention, (2) after completing the CSP, and (3) after an additional 3 months to evaluate longer-term outcomes. Feasibility assessment will include program retention and adherence. Reliable change analyses will examine treatment effects, with regression analyses to explore moderating effects of select patient, disease and treatment factors (e.g., severity of baseline cognitive impairment, number of brain lesions, cranial radiation dose and distribution). Results of this trial will inform further development and implementation of evidence-based supportive care for cognitively-impaired brain metastases patients.

Eligibility criteria: Inclusion Criteria:

* age 18 or older
* able to provide informed consent to all procedures
* diagnosis of one or more brain metastases, with primary cancer outside the CNS
* indication of cognitive deficits from self-report and/or cognitive testing
* interest in participating in a cognitive rehabilitation program
* able to complete study activities

Exclusion Criteria:

* concurrent non-cancer-related neurological or major psychiatric disorder or other medical condition suspected to influence cognition

Primary outcomes:
measure: Functional Assessment of Cancer Therapy - Cognitive
timeFrame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Secondary outcomes:
measure: Frontal Systems Behavior Scale
timeFrame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
measure: Hopkins Verbal Learning Test - Revised
timeFrame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
measure: Trail Making Test
timeFrame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
measure: Wechsler Digit Span Test
timeFrame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
measure: BADS Zoo Map Test
timeFrame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
measure: Controlled Oral Word Association Test
timeFrame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
measure: Functional Assessment of Cancer Therapy - Brain
timeFrame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
measure: Positive and Negative Affect Schedule
timeFrame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
measure: Illness Intrusiveness Rating Scale
timeFrame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References: