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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Stepped Care Program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Stepped Care Program (CSCP) | Behavioral | The Cognitive Stepped Care Program comprises two steps:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
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Patients:
Inclusion Criteria:
Exclusion Criteria:
Caregivers:
Inclusion Criteria:
Exclusion Criteria:
• N/A
Staff:
Inclusion Criteria:
Exclusion Criteria:
• N/A
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre, University Health Network | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
Not currently included in the approved protocol
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Intervention Efficacy (Preliminary) - Change in Cognitive Symptom Severity | Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog3) | Baseline and up to 4 months |
| Intervention Effectiveness (Preliminary) - Change in Perceived Self-Efficacy | Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS 4-item General Self-Efficacy) | Baseline and up to 4 months |
| 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) | Baseline and up to 4 months |
| Intervention Efficacy (Preliminary) - Change in Cancer-related Quality of Life - Brain-specific | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire BN-20 (EORTC QLQ-BN20) for brain-specific symptoms | Baseline and up to 4 months |
| Intervention Efficacy (Preliminary) - Perceptions | 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). | Up to 4 months |
| Intervention Adoption | 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. | Up to 1 year |
| Intervention Implementation - Factors Influencing CSCP Fidelity | 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). | Up to 1 year |
| Intervention Implementation - Perceptions | 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. | Up to 1 year |
| Intervention Maintenance | Staff interviews will explore anticipated facilitators and barriers to long-term implementation within standard care, including its impact on other services. | Up to 1 year |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |