140 Participants Needed

Cognitive Stepped Care Program for Brain Cancer

SM
SM
Overseen ByStacey Morrison, MSc, CCRP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Adults with brain metastases from any primary cancer, who are being followed up in the Brain Metastases Clinic, can join. They must be over 18, speak English, and able to consent. The trial is designed to help those experiencing cognitive issues due to their condition.

Inclusion Criteria

I am getting follow-up care for brain metastases.
I am 18 years old or older.
I can speak, read, and write in English.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tiered interventions based on cognitive symptom severity, ranging from no support to neuropsychological consultation

1 month

Follow-up

Participants are monitored for changes in cognitive symptoms, self-efficacy, and quality of life

4 months

Long-term Follow-up

Interviews and assessments to explore long-term implementation and maintenance of the CSCP

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Stepped Care Program (CSCP)

Trial Overview

The Cognitive Stepped Care Program (CSCP) is being tested for its feasibility and effectiveness. It involves routine screening of cognitive symptoms and provides tiered support based on severity—from educational materials to neuropsychological consultations.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Cognitive Stepped Care ProgramExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+