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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Exclusion Criteria:
- •Inclusion Criteria:
- •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
- •Exclusion Criteria:
研究者
Samantha Mayo
Clinician Investigator
University Health Network, Toronto