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
Qualifiers
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
Treatments tested in this trial
- Cognitive Stepped Care Program (CSCP)
Treatment groups
140 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov