Feasibility of a Cognitive Stepped Care Program for Adults With Brain Metastases
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Details and patient eligibility
About
Background: Cognitive symptoms are common and often severe in patients with brain metastases, significantly impacting their quality of life and ability to manage cancer care. Currently, there is no standard approach for routinely assessing and managing these symptoms in oncology clinics.
Objective: This study aims to evaluate the feasibility, acceptability, and preliminary efficacy of the Cognitive Stepped Care Program (CSCP) in a Brain Metastases Clinic.
Methods: This is a prospective, mixed-methods feasibility study involving patients with brain metastases, their caregivers, and clinic staff. Patients will undergo routine cognitive symptom screening using a standardized tool. Based on symptom severity, they will receive tiered interventions ranging from no support, to education materials, to computerized cognitive testing with individualized debrief, with group strategy training and/or neuropsychological consultation, as needed. Patients will complete questionnaires before and after the intervention regarding their symptoms and quality of life. Patients, caregivers and staff will provide their feedback about the intervention through questionnaires and interviews.
Outcomes: Primary outcomes include feasibility and acceptability of the CSCP. Secondary outcomes include preliminary changes in cognitive symptoms, self-efficacy, and quality of life.
Significance: This study will inform the potential integration of a structured cognitive support program into standard care for patients with brain metastases and may provide a model for similar interventions in other oncology settings.
Enrollment
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Ages
Volunteers
Inclusion and exclusion criteria
Patients:
Inclusion Criteria:
- Diagnosed with a brain metastasis for any primary cancer
- Receiving follow-up care in the Brain Metastases Clinic
- Adult (≥ 18 years)
- Able to speak, read, and write in English
- Able to provide written informed consent
Exclusion Criteria:
- History of significant developmental/learning disability or psychiatric disorder, acquired neurological disorder (e.g., traumatic brain injury)
- Poor performance status (ECOG ≥ 3)
- Life expectancy < 3 months
Caregivers:
Inclusion Criteria:
- Self-identified or identified by consenting patient as a primary caregiver for a person with brain metastases receiving follow-up in the Brain Metastases Clinic
- Adult (≥ 18 years)
- Able to speak, read, and write in English
- Able to provide written informed consent
Exclusion Criteria:
• N/A
Staff:
Inclusion Criteria:
- Currently working as a clinician or administrative staff member in the Brain Metastases Clinic
- Adult (≥ 18 years)
- Able to speak, read, and write in English
- Able to provide written informed consent
Exclusion Criteria:
• N/A
Trial design
Primary purpose
Allocation
Interventional model
Masking
140 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Samantha Mayo, RN, PhD; Stacey Morrison, MSc, CCRP
Data sourced from clinicaltrials.gov
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