Cognitive Support Program for Patients With Brain Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Functional Assessment of Cancer Therapy - Cognitive
研究概览
简要总结
This study evaluates the feasibility and preliminary efficacy of a brief cognitive-behavioural program designed to improve cognitive functioning in people with brain metastases.
详细描述
Cognitive impairments (such as problems with attention, executive functions, memory and language abilities) are common in people with brain metastases as a result of disease and/or treatment effects. These impairments can significantly limit functional independence, participation in valued roles and activities, and overall quality of life.
Building on research in other cognitively-impaired populations, we designed a brief, structured, patient-centered Cognitive Support Program (CSP) for brain metastases patients, who have the option of participating with a caregiver. Program contents include supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration). This prospective, single-arm study will enroll 24 brain metastases patients to evaluate the feasibility and preliminary efficacy of the CSP. A battery of outcome measures is administered (1) prior to intervention, (2) after completing the CSP, and (3) after an additional 3 months to evaluate longer-term outcomes. Feasibility assessment will include program retention and adherence. Reliable change analyses will examine treatment effects, with regression analyses to explore moderating effects of select patient, disease and treatment factors (e.g., severity of baseline cognitive impairment, number of brain lesions, cranial radiation dose and distribution). Results of this trial will inform further development and implementation of evidence-based supportive care for cognitively-impaired brain metastases patients.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 or older
- •able to provide informed consent to all procedures
- •diagnosis of one or more brain metastases, with primary cancer outside the CNS
- •indication of cognitive deficits from self-report and/or cognitive testing
- •interest in participating in a cognitive rehabilitation program
- •able to complete study activities
排除标准
- •concurrent non-cancer-related neurological or major psychiatric disorder or other medical condition suspected to influence cognition
研究组 & 干预措施
Cognitive Support Program
Three individual sessions of supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration), with practice applying program content between sessions.
干预措施: Cognitive Support Program (Behavioral)
结局指标
主要结局
Functional Assessment of Cancer Therapy - Cognitive
时间窗: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Multi-domain cognitive symptom questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
次要结局
- Hopkins Verbal Learning Test - Revised(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- Frontal Systems Behavior Scale(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- Controlled Oral Word Association Test(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- Trail Making Test(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- Wechsler Digit Span Test(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- Functional Assessment of Cancer Therapy - Brain(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- Illness Intrusiveness Rating Scale(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- BADS Zoo Map Test(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- Positive and Negative Affect Schedule(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))
- Hospital Anxiety and Depression Scale(Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training))