Expanding Caregiving Capacities for Caregivers of Older Adults With Newly Diagnosed Advanced Lung Cancer: A Study of Current Status and Evaluation of the Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model (ICSM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC)
研究概览
简要总结
This two-phase study aims to examine the current status of older adults with newly diagnosed locally advanced or advanced non-small cell lung cancer and their primary family caregivers, and to evaluate the effects of the Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model (ICSM). Phase I is a cross-sectional correlational study assessing distress, unmet care needs, resource awareness and utilization, social support, and health promotion practice. Phase II is a two-group randomized controlled trial comparing ICSM plus oncology case manager care with oncology case manager care and usual hospital care. The intervention includes nurse-led education and counseling, symptom management, emotional coping, problem-solving, social resource use, caregiving activity arrangement, and use of a web-based or LINE-based integrated resource system.
详细描述
This study is designed as a two-phase, three-year study. Phase I is a cross-sectional correlational study conducted to examine physical and psychological distress, daily function, unmet care needs, knowledge and utilization of resources, social support, and health promotion practice among older adults with locally advanced or advanced non-small cell lung cancer and their primary family caregivers.
Phase II is a two-group, 12-month randomized controlled trial. Eligible patient-caregiver dyads will be randomized to either an experimental group receiving the Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model (ICSM) plus oncology case manager care, or a control group receiving oncology case manager care and usual hospital care. The ICSM intervention includes nurse-led education and counseling and use of an information and resource platform designed to support lung cancer care, caregiver self-care, distress management, and health promotion.
The main intervention components include understanding non-small cell lung cancer treatment recommendations, symptom detection and management, care of aging-related problems, coping with emotional distress, problem-solving and social resource use, maintaining social function during caregiving, relaxation skills, and use of information and resources related to cancer care, long-term care, and caregiver support. Outcomes will be assessed at baseline and at follow-up time points after the first treatment. Generalized estimating equations will be used to examine intervention effects over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
No masking is used because participants and intervention providers are aware of the assigned supportive care intervention.
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
- •Patient inclusion criteria:
- •Older adults with newly diagnosed locally advanced or advanced non-small cell lung cancer.
- •Stage III or stage IV non-small cell lung cancer.
- •Aware of their cancer diagnosis.
- •Preparing to receive anti-cancer medical treatment.
- •Able to communicate verbally and complete study assessments.
- •Willing to participate in the study and provide written informed consent.
- •Caregiver inclusion criteria:
- •Adult aged 18 years or older.
- •Identified by the eligible patient as the fixed primary family caregiver.
- •Able to participate in the study together with the patient as a patient-caregiver dyad.
- •Willing to participate in the study and provide written informed consent.
排除标准
- •Patient exclusion criteria:
- •- Severe cognitive impairment that prevents completion of study questionnaires or assessments.
- •Caregiver exclusion criteria:
- •Unable to communicate sufficiently to complete study assessments.
- •Unable or unwilling to provide written informed consent.
结局指标
主要结局
Change in Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC)
时间窗: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
Caregiver quality of life will be assessed using the Caregiver Quality of Life Index-Cancer (CQOLC). The CQOLC is a 35-item instrument using a 5-point Likert-type scale from 0 to 4 to assess quality of life among family caregivers of patients with cancer, including physical, emotional, family, and social functioning. The total score ranges from 0 to 140, with higher scores indicating better caregiver quality of life after reverse scoring of negatively worded items.
次要结局
- Change in Caregiver Resource Utilization as Measured by the Resource and Utilization Assessment Scale(Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment)
- Change in Caregiver Strain as Measured by the Caregiver Strain Index(Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment)
- Change in Caregiver Anxiety as Measured by the Generalized Anxiety Disorder-7 Scale(Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment)
- Change in Caregiver Depressive Symptoms as Measured by the Patient Health Questionnaire-9(Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment)
- Change in Caregiver Sleep Quality as Measured by the Pittsburgh Sleep Quality Index(Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment)
- Change in Patient Quality of Life and Lung Cancer-Related Symptoms as Measured by the EORTC QLQ-C30 and EORTC QLQ-LC13(Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment)
- Change in Patient Supportive Care Needs as Measured by the Supportive Care Needs Survey-Screening Tool Chinese Version(Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment)