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

January 12, 2026 updated by: Samantha Mayo, University Health Network, Toronto

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre, University Health Network
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Stepped Care Program
Behavioral: Cognitive 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Completion Rate
Time Frame: Through study completion, an average of 1 month
Proportion of patients who are able to complete the CSCP (i.e. complete the cognitive symptom management intervention as allocated to them based on cognitive screening score)
Through study completion, an average of 1 month
Intervention Satisfaction
Time Frame: Through study completion, an average of 1 month
Rating on a 5-point Likert scale (0-poor to 4-excellent), with optional open-text item for additional comments
Through study completion, an average of 1 month
Descriptions of Feasibility
Time Frame: Through study completion, an average of 1 month
Post-intervention qualitative interviews with participants (patients/caregivers one week after their last interaction of the CSCP, or staff at the completion of the study period) will also explore their perceptions of the feasibility and acceptability of the CSCP, including suggestions for improvement of the intervention.
Through study completion, an average of 1 month
Recruitment Rate
Time Frame: Baseline
Proportion of eligible participants who are enrolled in the study
Baseline
Retention Rate
Time Frame: Through study completion, an average of 1 month
Proportion of patients who complete the study (i.e. pre-post data collection)
Through study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Reach
Time Frame: Baseline
We will examine the representativeness of the patients were enrolled in the CSCP. For all consented patient participants, we will collect demographic and clinical information through a study-specific questionnaire and a review of health records. This will be compared to historical patient demographics from the study setting.
Baseline
Intervention Efficacy (Preliminary) - Change in Cognitive Symptom Severity
Time Frame: Baseline and up to 4 months
Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog3)
Baseline and up to 4 months
Intervention Effectiveness (Preliminary) - Change in Perceived Self-Efficacy
Time Frame: Baseline and up to 4 months
Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS 4-item General Self-Efficacy)
Baseline and up to 4 months
Intervention Effectiveness (Preliminary) - Change in Cancer-related Quality of Life
Time Frame: Baseline and up to 4 months
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30)
Baseline and up to 4 months
Intervention Efficacy (Preliminary) - Change in Cancer-related Quality of Life - Brain-specific
Time Frame: Baseline and up to 4 months
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire BN-20 (EORTC QLQ-BN20) for brain-specific symptoms
Baseline and up to 4 months
Intervention Efficacy (Preliminary) - Perceptions
Time Frame: Up to 4 months
Post-intervention qualitative interviews will include questions about what participants found most valuable (patients, caregivers, staff), the impact on their overall well-being (patients), and if there were, any negative experience associated with the CSCP (patients, caregivers, staff).
Up to 4 months
Intervention Adoption
Time Frame: Up to 1 year
Post-intervention qualitative interviews will explore perceptions from patients, caregivers, and staff about the potential motivations for the adoption of the CSCP within the Brain Metastasis clinic and/or the organization more broadly. Questions will also gauge facilitators and barriers to this adoption.
Up to 1 year
Intervention Implementation - Factors Influencing CSCP Fidelity
Time Frame: Up to 1 year
From CSCP case logs, we will collect the time spent per patient on the CSCP, any adverse events, and any challenges to implementation fidelity (e.g., scheduling, technical issues).
Up to 1 year
Intervention Implementation - Perceptions
Time Frame: Up to 1 year
Interviews with patients, caregivers, and staff will gather feedback on challenges to implementation and what strategies, tools, or infrastructure would need to be developed to better ensure that the intervention is delivered as intended.
Up to 1 year
Intervention Maintenance
Time Frame: Up to 1 year
Staff interviews will explore anticipated facilitators and barriers to long-term implementation within standard care, including its impact on other services.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

December 31, 2025

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-5444.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not currently included in the approved protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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