Feasibility of a Cognitive Stepped Care Program for Adults With Brain Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
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
Trial design
Design model
Single group
Treatments tested in this trial
Cognitive Stepped Care Program (CSCP)
BehavioralThe 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.
Treatment groups
140 Participants
are divided into 1 treatment groupGroup A: Cognitive Stepped Care ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Through study completion, an average of 1 month2
Intervention Satisfaction
Rating on a 5-point Likert scale (0-poor to 4-excellent), with optional open-text item for additional comments
Time frame
Through study completion, an average of 1 month3
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.
Time frame
Through study completion, an average of 1 month4
Recruitment Rate
Proportion of eligible participants who are enrolled in the study
Time frame
BaselineSecondary outcomes
1
Intervention Reach
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.
Time frame
Baseline2
Intervention Efficacy (Preliminary) - Change in Cognitive Symptom Severity
Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog3)
Time frame
Baseline and up to 4 months3
Intervention Effectiveness (Preliminary) - Change in Perceived Self-Efficacy
Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS 4-item General Self-Efficacy)
Time frame
Baseline and up to 4 months4
Intervention Effectiveness (Preliminary) - Change in Cancer-related Quality of Life
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30)
Time frame
Baseline and up to 4 monthsSponsors and contacts
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Source ClinicalTrials.gov