Nurse-Led Caregiver Support for Older Adults With Advanced Lung Cancer

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model
  The ICSM is a nurse-led supportive care intervention designed for older adults with advanced non-small cell lung cancer and their primary family caregivers. It includes structured education and counseling, symptom detection and management, care of aging-related problems, coping with emotional distress, problem-solving, social resource utilization, maintenance of social function during caregiving, and use of an integrated web-based or mobile messaging-based resource platform.
• Другое Oncology Case Manager Care and Usual Care
  Participants receive routine oncology case manager care and usual hospital care according to standard clinical practice. This may include routine cancer care, standard follow-up, clinical consultation, and support provided through the hospital's usual care process.

Первичные конечные точки

• Change in Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC) [Срок оценки: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment]

Вторичные конечные точки (7)

• Change in Caregiver Resource Utilization as Measured by the Resource and Utilization Assessment Scale [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 2 центра

• National Taiwan University Hospital — Taipei
• National Taiwan University Cancer Center — Taipei

Идентификаторы

NCT: NCT07708870 · 202404134RINC · NSTC 113-2314-B-002-137

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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