Brain Metastases, Brain Metastasis
Conditions
Keywords
cancer-related cognitive impairment, brain metastases, brain metastasis, stepped care, symptom management
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.
Interventions
BEHAVIORALCognitive 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.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Completion Rate | 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) |
| Intervention Satisfaction | 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 |
| Descriptions of Feasibility | 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. |
| Recruitment Rate | Baseline | Proportion of eligible participants who are enrolled in the study |
| Retention Rate | Through study completion, an average of 1 month | Proportion of patients who complete the study (i.e. pre-post data collection) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Reach | 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. |
| Intervention Efficacy (Preliminary) - Change in Cognitive Symptom Severity | Baseline and up to 4 months | Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog3) |
| Intervention Effectiveness (Preliminary) - Change in Perceived Self-Efficacy | Baseline and up to 4 months | Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS 4-item General Self-Efficacy) |
| Intervention Effectiveness (Preliminary) - Change in Cancer-related Quality of Life | Baseline and up to 4 months | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30) |
| Intervention Efficacy (Preliminary) - Change in Cancer-related Quality of Life - Brain-specific | 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 |
| Intervention Efficacy (Preliminary) - Perceptions | 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). |
| Intervention Adoption | 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. |
| Intervention Implementation - Factors Influencing CSCP Fidelity | 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). |
| Intervention Implementation - Perceptions | 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. |
| Intervention Maintenance | 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. |
Countries
Canada
Contacts
CONTACTSamantha Mayo, RN, PhD
CONTACTStacey Morrison, MSc, CCRP
Outcome results
None listed