Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07355348

Feasibility of a Cognitive Stepped Care Program for Adults With Brain Metastases

Led by University Health Network, Toronto · Updated on 2026-01-21

140

Participants Needed

1

Research Sites

20 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Feasibility of a Cognitive Stepped Care Program for Adults With Brain Metastases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with a brain metastasis from any primary cancer
  • Receiving follow-up care in the Brain Metastases Clinic
  • Adult (18 years or older)
  • Able to speak, read, and write in English
  • Able to provide written informed consent
  • Self-identified or identified primary caregiver for a person with brain metastases receiving follow-up in the Brain Metastases Clinic (for caregivers)
  • Currently working as a clinician or administrative staff member in the Brain Metastases Clinic (for staff)
Not Eligible

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 of 3 or higher)
  • Life expectancy less than 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Princess Margaret Cancer Centre, University Health Network

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

S

Samantha Mayo, RN, PhD

CONTACT

S

Stacey Morrison, MSc, CCRP

CONTACT

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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Feasibility of a Cognitive Stepped Care Program for Adults With Brain Metastases | DecenTrialz