RecruitingNot ApplicableNCT07355348

Feasibility of a 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


Sponsor

University Health Network, Toronto

Enrollment

140 participants

Start Date

Jan 9, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the feasibility of a "cognitive stepped care" program — a structured approach that provides different levels of cognitive and emotional support based on need — for adults living with brain metastases (cancer that has spread to the brain). The study also includes caregivers and clinic staff. **You may be eligible if (as a patient):** - You have been diagnosed with a brain metastasis from any primary cancer - You are an adult aged 18 or older - You are receiving follow-up care at the Brain Metastases Clinic - You can read, speak, and write English - Your life expectancy is at least 3 months - Your general health is adequate (ECOG performance status 0–2) **You may NOT be eligible if:** - You have a significant pre-existing developmental disability, psychiatric disorder, or acquired brain condition (such as a traumatic brain injury) - Your general health is very poor (ECOG 3 or worse) - Your life expectancy is less than 3 months Caregivers and clinic staff may also be eligible — speak with the research team for details. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive Stepped Care Program (CSCP)

The Cognitive Stepped Care Program comprises two steps: 1. Cognitive Symptom Screening: Patients will complete a 10-item cognitive screening tool. Each item is rated from 0-10, with thresholds for mild, moderate and severe symptoms. 2. Cognitive Symptom Management. Patients will receive a cognitive symptom management intervention tailored to their symptom severity. Symptom management interventions will be based on the highest response score across the 10-item screening tool, ranging from no support (no symptoms), to educational materials (mild symptoms), to computerized cognitive testing with an individualized debrief (moderate-severe symptoms), with group strategy training and/or neuropsychological consultation provided as needed.


Locations(1)

Princess Margaret Cancer Centre, University Health Network

Toronto, Ontario, Canada

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NCT07355348


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