Cognitive Support Program for Patients With Brain Metastases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastases, CNS
- Sponsor
- University Health Network, Toronto
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Functional Assessment of Cancer Therapy - Cognitive
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Functional Assessment of Cancer Therapy - Cognitive
Time Frame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Multi-domain cognitive symptom questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Secondary Outcomes
- Hopkins Verbal Learning Test - Revised(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- Frontal Systems Behavior Scale(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- Controlled Oral Word Association Test(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- Trail Making Test(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- Wechsler Digit Span Test(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- Functional Assessment of Cancer Therapy - Brain(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- Illness Intrusiveness Rating Scale(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- BADS Zoo Map Test(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- Positive and Negative Affect Schedule(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- Hospital Anxiety and Depression Scale(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))