Feasibility of a Cognitive Stepped Care Program for Adults With Brain Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Stepped Care Program (CSCP).
- Who it may be relevant to
- Registry conditions: Brain Metastases, Brain Metastasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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 sup
Primary outcome measures
- Intervention Completion Rate [Time frame: Through study completion, an average of 1 month]
- Intervention Satisfaction [Time frame: Through study completion, an average of 1 month]
- Descriptions of Feasibility [Time frame: Through study completion, an average of 1 month]
- Recruitment Rate [Time frame: Baseline]
- Retention Rate [Time frame: Through study completion, an average of 1 month]
Secondary outcome measures (10)
- Intervention Reach [Time frame: Baseline]
- Intervention Efficacy (Preliminary) - Change in Cognitive Symptom Severity [Time frame: Baseline and up to 4 months]
- Intervention Effectiveness (Preliminary) - Change in Perceived Self-Efficacy [Time frame: Baseline and up to 4 months]
- Intervention Effectiveness (Preliminary) - Change in Cancer-related Quality of Life [Time frame: 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]
- Intervention Efficacy (Preliminary) - Perceptions [Time frame: Up to 4 months]
- Intervention Adoption [Time frame: Up to 1 year]
- Intervention Implementation - Factors Influencing CSCP Fidelity [Time frame: Up to 1 year]
- Intervention Implementation - Perceptions [Time frame: Up to 1 year]
- Intervention Maintenance [Time frame: Up to 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Canada · 1 center
- Princess Margaret Cancer Centre, University Health Network — Toronto
Identifiers
NCT: NCT07355348 · 25-5444.0