Feasibility of a Cognitive Stepped Care Program for Adults With Brain Metastases

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Intervention Completion Rate [Срок оценки: Through study completion, an average of 1 month]
• Intervention Satisfaction [Срок оценки: Through study completion, an average of 1 month]
• Descriptions of Feasibility [Срок оценки: Through study completion, an average of 1 month]
• Recruitment Rate [Срок оценки: Baseline]
• Retention Rate [Срок оценки: Through study completion, an average of 1 month]

Вторичные конечные точки (10)

• Intervention Reach [Срок оценки: Baseline]
• Intervention Efficacy (Preliminary) - Change in Cognitive Symptom Severity [Срок оценки: Baseline and up to 4 months]
• Intervention Effectiveness (Preliminary) - Change in Perceived Self-Efficacy [Срок оценки: Baseline and up to 4 months]
• Intervention Effectiveness (Preliminary) - Change in Cancer-related Quality of Life [Срок оценки: Baseline and up to 4 months]
• Intervention Efficacy (Preliminary) - Change in Cancer-related Quality of Life - Brain-specific [Срок оценки: Baseline and up to 4 months]
• Intervention Efficacy (Preliminary) - Perceptions [Срок оценки: Up to 4 months]
• Intervention Adoption [Срок оценки: Up to 1 year]
• Intervention Implementation - Factors Influencing CSCP Fidelity [Срок оценки: Up to 1 year]
• Intervention Implementation - Perceptions [Срок оценки: Up to 1 year]
• Intervention Maintenance [Срок оценки: Up to 1 year]

Критерии участия

Patients:

Критерии включения

• 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

Критерии исключения

• 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:

Критерии включения

• 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

Критерии исключения

• N/A

Staff:

Критерии включения

• 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

Критерии исключения

• N/A

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• Princess Margaret Cancer Centre, University Health Network — Toronto

Идентификаторы

NCT: NCT07355348 · 25-5444.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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