Nurse-Led Caregiver Support for Older Adults With Advanced Lung Cancer (ICSM)
12 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
120
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Taipei
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Taipei, Taipei, Taiwán, 100225
- Reclutamiento
- National Taiwan University Hospital
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Contacto:
- Yeur-Hur Lai, PhD
- Número de teléfono: 288429 +886-2-2312-3456
- Correo electrónico: laiyhwk@ntu.edu.tw
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Taipei, Taipei, Taiwán, 106
- Reclutamiento
- National Taiwan University Cancer Center
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Contacto:
- Yeur-Hur Lai, PhD
- Número de teléfono: 288429 +886-2-2312-3456
- Correo electrónico: laiyhwk@ntu.edu.tw
-
Investigador principal:
- Yeur-Hur Lai, PhD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
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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Comparador activo: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC)
Periodo de tiempo: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Caregiver Resource Utilization as Measured by the Resource and Utilization Assessment Scale
Periodo de tiempo: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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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
Periodo de tiempo: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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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
Periodo de tiempo: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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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
Periodo de tiempo: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de abril de 2025
Finalización primaria (Estimado)
1 de junio de 2027
Finalización del estudio (Estimado)
1 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
12 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de julio de 2026
Publicado por primera vez (Actual)
16 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Síntomas de comportamiento
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Neoplasias Pulmonares
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Estrés Psicológico
- Comportamiento
- Carga del cuidador
- Carcinoma de pulmón de células no pequeñas
Otros números de identificación del estudio
- 202404134RINC
- NSTC 113-2314-B-002-137 (Otro número de subvención/financiamiento: National Science and Technology Council, Taiwan)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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