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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 31, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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