Actively Recruiting
Codesign of a Cognitive Stepped Care Program to Enhance Quality of Life in Adults With Brain Metastases: Evaluation of Feasibility, Acceptability, and Preliminary Efficacy
Led by University Health Network, Toronto · Updated on 2026-01-21
140
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cognitive symptoms are common and often severe in patients with brain metastases, affecting their quality of life and ability to manage cancer care. Currently, no standard method exists for routine assessment and management of these symptoms in oncology clinics. This study evaluates the feasibility, acceptability, and early effectiveness of the Cognitive Stepped Care Program (CSCP) in a Brain Metastases Clinic setting. The Cognitive Stepped Care Program involves two key steps: first, patients complete a 10-item cognitive symptom screening tool that rates symptoms from 0 to 10 to identify severity. Based on the screening results, patients receive tailored interventions ranging from no support for no symptoms, educational materials for mild symptoms, to computerized cognitive testing with individualized feedback for moderate to severe symptoms. Additional group strategy training or neuropsychological consultations may be provided as needed. Participants will complete questionnaires before and after the intervention to report their symptoms and quality of life. Feedback will also be gathered from patients, caregivers, and clinic staff through questionnaires and interviews. The study measures include intervention completion and satisfaction rates, recruitment and retention rates, and preliminary changes in cognitive symptoms, self-efficacy, and cancer-related quality of life. The study duration averages around one month for intervention completion, with follow-up for up to four months and adoption and implementation factors monitored up to one year.
CONDITIONS
Brief Title
Feasibility of a Cognitive Stepped Care Program for Adults With Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with brain metastasis from any primary cancer
- Receiving follow-up care in the Brain Metastases Clinic
- Adult aged 18 years or older
- Able to speak, read, and write in English
- Able to provide written informed consent
You will not qualify if you...
- History of significant developmental or learning disability, psychiatric disorder, or acquired neurological disorder such as traumatic brain injury
- Poor performance status (ECOG 3 or higher)
- Life expectancy less than 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 month
Participants complete a cognitive symptom screening and receive tailored cognitive symptom management based on their symptom severity, which may include educational materials, computerized cognitive testing, and group strategy training or neuropsychological consultation as needed.
1 baseline visit and follow-up visits as needed during the month
Duration - Up to 1 year
Participants are monitored for changes in cognitive symptoms, self-efficacy, and quality of life up to 4 months, with additional assessments related to intervention adoption and implementation up to 1 year.
Periodic follow-up visits up to 1 year
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre, University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
S
Samantha Mayo, RN, PhD
S
Stacey Morrison, MSc, CCRP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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