Feasibility of a Cognitive Stepped Care Program for Adults With Brain Metastases
Recruiting now NCT07355348
Run by University Health Network, Toronto · for 18 and older · All sexes
What this study is 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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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
🚫 You may not be able to join if…
- 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:
✅ You may be able to join if…
- 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
🚫 You may not be able to join if…
- N/A Staff:
✅ You may be able to join if…
- 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
🚫 You may not be able to join if…
- N/A
Where this trial is running
- Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada
Who to contact
Samantha Mayo, RN, PhD · 1-437-218-0860 · samantha.mayo@uhn.ca
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07355348.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.