Cognitive stepped care program for adults with brain metastases
Codesign of a Cognitive Stepped Care Program (CSCP) to Enhance Quality of Life in Adults With Brain Metastases: Evaluation of Feasibility, Acceptability and Preliminary Efficacy
This project will test whether routine screening plus a stepped program of education and tailored cognitive support can help adults with brain metastases manage thinking and memory problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07355348 on ClinicalTrials.gov |
What this trial studies
This is a prospective, mixed-methods feasibility project enrolling adults with brain metastases, their caregivers, and clinic staff at a specialized brain metastases clinic. Patients will receive routine cognitive symptom screening with a standardized tool and, based on symptom severity, be routed into tiered interventions ranging from education materials to computerized cognitive testing with individualized debriefing, group strategy training, and neuropsychological consultation as needed. Outcomes include measures of feasibility and acceptability, preliminary changes in cognitive symptoms and related questionnaires completed before and after the program, and qualitative feedback from patients, caregivers, and staff. The goal is to refine the intervention and implementation approach for broader use if it proves acceptable and feasible.
Who should consider this trial
Good fit: Adults (≥18) with a diagnosed brain metastasis receiving follow-up care at the Brain Metastases Clinic who can read and speak English, can provide consent, have ECOG performance status <3, and an expected life expectancy of at least 3 months.
Not a fit: Patients who are non-English speakers, have poor performance status (ECOG ≥3), life expectancy under 3 months, or pre-existing significant developmental, neurological, or psychiatric conditions were excluded and are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could improve detection of cognitive problems and provide timely, tailored support that helps patients maintain daily functioning and quality of life.
How similar studies have performed: Cognitive rehabilitation and stepped-care approaches in other cancer populations have shown some promising results, but a stepped care program tailored specifically for people with brain metastases is relatively new and not well tested.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre, University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Samantha Mayo, RN, PhD
- Email: samantha.mayo@uhn.ca
- Phone: 1-437-218-0860
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.