Cognitive Support Program for Patients With Brain Metastases

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cognitive Support Program for Patients With Brain Metastases

Conditions
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Metastases, CNS

Intervention / Treatment
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* Behavioral: Cognitive Support Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Support Program<br>Three individual sessions of supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration), with practice applying program content between sessions. | Behavioral: Cognitive Support Program<br>* Three individual sessions of supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration), with practice applying program content between sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy - Cognitive | 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. | Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frontal Systems Behavior Scale | Executive 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. | Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training) | 
| Hopkins Verbal Learning Test - Revised | Neurocognitive test of memory 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. | Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training) | 
| Trail Making Test | Neurocognitive test of processing speed and executive function 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. | Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training) | 
| Wechsler Digit Span Test | Neurocognitive test of working memory 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. | Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training) | 
| BADS Zoo Map Test | Neurocognitive test of executive function 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. | Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training) | 
| Controlled Oral Word Association Test | Neurocognitive test of verbal fluency 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. | Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training) | 
| Functional Assessment of Cancer Therapy - Brain | Health-related quality of life 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. | Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training) | 
| Positive and Negative Affect Schedule | Quality of life (well-being) 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. | Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training) | 
| Hospital Anxiety and Depression Scale | Quality of life (psychological distress) 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. | Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training) | 
| Illness Intrusiveness Rating Scale | Quality of life (activity participation) 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. | Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training) |