Nurse-Led Caregiver Support for Older Adults With Advanced Lung Cancer (ICSM)
12 de julho de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
120
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Taipei
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Taipei, Taipei, Taiwan, 100225
- Recrutamento
- National Taiwan University Hospital
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Contato:
- Yeur-Hur Lai, PhD
- Número de telefone: 288429 +886-2-2312-3456
- E-mail: laiyhwk@ntu.edu.tw
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Taipei, Taipei, Taiwan, 106
- Recrutamento
- National Taiwan University Cancer Center
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Contato:
- Yeur-Hur Lai, PhD
- Número de telefone: 288429 +886-2-2312-3456
- E-mail: laiyhwk@ntu.edu.tw
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Investigador principal:
- Yeur-Hur Lai, PhD
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
Outros nomes:
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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Caregiver Resource Utilization as Measured by the Resource and Utilization Assessment Scale
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de abril de 2025
Conclusão Primária (Estimado)
1 de junho de 2027
Conclusão do estudo (Estimado)
1 de junho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
12 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de julho de 2026
Primeira postagem (Real)
16 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Sintomas Comportamentais
- Doenças Respiratórias
- Doenças pulmonares
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Neoplasias Pulmonares
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Estresse, Psicológico
- Comportamento
- Sobrecarga do cuidador
- Carcinoma pulmonar de células não pequenas
Outros números de identificação do estudo
- 202404134RINC
- NSTC 113-2314-B-002-137 (Número de outro subsídio/financiamento: National Science and Technology Council, Taiwan)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .