Metastases, CNS Clinical Trial
Official title:
Cognitive Support Program for Patients With Brain Metastases
This study evaluates the feasibility and preliminary efficacy of a brief cognitive-behavioural program designed to improve cognitive functioning in people with brain metastases.
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.
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