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

NCT07355348 | Recruiting

• 1 other identifier: 25-5444.0
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Metastases; Brain Metastasis

Keywords

cancer-related cognitive impairment; brain metastases; brain metastasis; stepped care; symptom management

Outcome Measures

Primary Outcomes (5)

• Intervention Completion Rate

  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

  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

  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

  Proportion of eligible participants who are enrolled in the study

  Baseline

• Retention Rate

  Proportion of patients who complete the study (i.e. pre-post data collection)

  Through study completion, an average of 1 month

Secondary Outcomes (10)

• Intervention Reach

  Baseline

• Intervention Efficacy (Preliminary) - Change in Cognitive Symptom Severity

  Baseline and up to 4 months

• Intervention Effectiveness (Preliminary) - Change in Perceived Self-Efficacy

  Baseline and up to 4 months

• Intervention Effectiveness (Preliminary) - Change in Cancer-related Quality of Life

  Baseline and up to 4 months

• Intervention Efficacy (Preliminary) - Change in Cancer-related Quality of Life - Brain-specific

  Baseline and up to 4 months

Study Arms (1)

Cognitive Stepped Care Program

EXPERIMENTAL

Behavioral: Cognitive Stepped Care Program (CSCP)

Interventions

Cognitive Stepped Care Program (CSCP) BEHAVIORAL

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.

Cognitive Stepped Care Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• N/A
• Staff:
• 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
• N/A

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre, University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Samantha Mayo, RN, PhD

CONTACT

1-437-218-0860; samantha.mayo@uhn.ca

Stacey Morrison, MSc, CCRP

CONTACT

1-437-219-2807; stacey.morrison@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Investigator

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 21, 2026
• Study Start: January 9, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)