Nurse-Led Caregiver Support for Older Adults With Advanced Lung Cancer (ICSM)
12 июля 2026 г. обновлено: National Taiwan University Hospital
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)
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.
Обзор исследования
Статус
Рекрутинг
Условия
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
120
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Taipei
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Taipei, Taipei, Тайвань, 100225
- Рекрутинг
- National Taiwan University Hospital
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Контакт:
- Yeur-Hur Lai, PhD
- Номер телефона: 288429 +886-2-2312-3456
- Электронная почта: laiyhwk@ntu.edu.tw
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Taipei, Taipei, Тайвань, 106
- Рекрутинг
- National Taiwan University Cancer Center
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Контакт:
- Yeur-Hur Lai, PhD
- Номер телефона: 288429 +886-2-2312-3456
- Электронная почта: laiyhwk@ntu.edu.tw
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Главный следователь:
- Yeur-Hur Lai, PhD
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: ICSM Plus Oncology Case Manager Care
Participants in this group receive the Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model (ICSM) in addition to 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.
|
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.
Другие имена:
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.
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Активный компаратор: Oncology Case Manager Care and Usual Care
Participants in this group receive oncology case manager care and usual hospital care.
This includes routine cancer care, standard follow-up, and support provided through the hospital's usual care process.
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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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC)
Временное ограничение: 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.
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Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Caregiver Resource Utilization as Measured by the Resource and Utilization Assessment Scale
Временное ограничение: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
|
Caregiver resource utilization will be assessed using the Resource and Utilization Assessment Scale.
The scale evaluates caregivers' awareness and use of health-related, social, community, and professional resources.
Higher scores indicate greater resource awareness and utilization.
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Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
|
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Change in Caregiver Strain as Measured by the Caregiver Strain Index
Временное ограничение: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
|
Caregiver strain will be assessed using the Caregiver Strain Index (CSI).
The CSI is a 13-item instrument that measures perceived and reported strain among caregivers across employment, financial, social, physical, and time-related domains.
Higher scores indicate greater caregiver strain.
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Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
|
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Change in Caregiver Anxiety as Measured by the Generalized Anxiety Disorder-7 Scale
Временное ограничение: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
|
Caregiver anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale.
The GAD-7 includes 7 items scored from 0 to 3, with a total score ranging from 0 to 21.
Higher scores indicate greater anxiety symptoms.
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Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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Change in Caregiver Depressive Symptoms as Measured by the Patient Health Questionnaire-9
Временное ограничение: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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Caregiver depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9).
The PHQ-9 includes 9 items scored from 0 to 3, with a total score ranging from 0 to 27.
Higher scores indicate greater depressive symptom severity.
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Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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Change in Caregiver Sleep Quality as Measured by the Pittsburgh Sleep Quality Index
Временное ограничение: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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Caregiver sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
The PSQI total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
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Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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Change in Patient Quality of Life and Lung Cancer-Related Symptoms as Measured by the EORTC QLQ-C30 and EORTC QLQ-LC13
Временное ограничение: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
|
Patient quality of life and lung cancer-related symptoms will be assessed using the EORTC QLQ-C30 and EORTC QLQ-LC13.
Scores are transformed to a 0 to 100 scale.
Higher scores on global health and functional scales indicate better functioning or quality of life, whereas higher scores on symptom scales indicate greater symptom burden.
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Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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Change in Patient Supportive Care Needs as Measured by the Supportive Care Needs Survey-Screening Tool Chinese Version
Временное ограничение: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
|
Patient supportive care needs will be assessed using the Supportive Care Needs Survey-Screening Tool Chinese Version (SCNS-ST9-C) and study-specific additional items.
Higher scores indicate greater unmet supportive care needs.
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Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
8 апреля 2025 г.
Первичное завершение (Оцененный)
1 июня 2027 г.
Завершение исследования (Оцененный)
1 июня 2027 г.
Даты регистрации исследования
Первый отправленный
12 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
12 июля 2026 г.
Первый опубликованный (Действительный)
16 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
16 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
12 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Новообразования по локализации
- Новообразования
- Поведенческие симптомы
- Заболевания дыхательных путей
- Легочные заболевания
- Новообразования дыхательных путей
- Грудные новообразования
- Новообразования легких
- Рак, Бронхогенный
- Бронхиальные новообразования
- Стресс, Психологический
- Поведение
- Бремя воспитателя
- Карцинома немелкоклеточного легкого
Другие идентификационные номера исследования
- 202404134RINC
- NSTC 113-2314-B-002-137 (Другой номер гранта/финансирования: National Science and Technology Council, Taiwan)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
Individual participant data will not be shared because this study collects sensitive health-related and psychosocial information from older adults with advanced lung cancer and their family caregivers.
Data access and use will be limited to the approved study team and the purposes specified in the IRB-approved protocol and informed consent documents.
Aggregate results may be reported in publications, presentations, or study reports.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .