The Impact of Symptom Management Nursing Intervention on the QoL of Patients With Advanced Lung Cancer: Mediation of Self-management Efficacy and Regulation of Psychological Resilience
25 de junho de 2026 atualizado por: Jie Zeng
Dahua Hospital, Xuhui District, Shanghai
Symptom management nursing intervention can improve the self-management efficacy, psychological resilience, and QoL of patients with advanced lung cancer.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Self management efficacy is an important mediating variable in the impact of Symptom management nursing intervention on patients' quality of life.
Psychological resilience plays a negative moderating role in the effect of Symptom management nursing intervention.
Late stage lung cancer patients with low psychological resilience can obtain more significant self management efficacy and quality of life improvement from Symptom management nursing intervention, and are the key beneficiaries of the intervention.
Tipo de estudo
Intervencional
Inscrição (Real)
176
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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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200031
- Dahua Hospital, Xuhui District, Shanghai
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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:
- According to the diagnostic criteria of primary lung cancer [9], the clinical stage was stage ⅢB-Ⅳ
- aged 18-75 years old
- Karnofsky performance status (KPS) ≥60 and expected survival ≥3 months
- Patients had clear consciousness and normal cognitive function, and could complete the questionnaire independently or with the assistance of the researcher
- have basic communication skills and can cooperate to complete the whole intervention
- Patients or their families informed and signed the consent form.
Exclusion Criteria:
- primary malignant tumors in other parts
- history of severe heart, liver, kidney and other important organ failure, severe infection or mental illness
- Unable to cooperate with the study due to cognitive impairment, visual and hearing impairment
- participating in other similar nursing intervention studies.
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: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: Routine nursing group
Patients in the routine group were given routine care, including disease monitoring, medication care, diet and nutrition guidance, basic life care, routine health education on admission and discharge, symptomatic treatment of patients' discomfort symptoms, telephone follow-up twice a week to understand the patient's condition, and no systematic and personalized SM nursing intervention.
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Patients in the routine group were given routine care, including disease monitoring, medication care, diet and nutrition guidance, basic life care, routine health education on admission and discharge, symptomatic treatment of patients' discomfort symptoms, telephone follow-up twice a week to understand the patient's condition, and no systematic and personalized SM nursing intervention.
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Outro: standardized systematic SM nursing group
On the basis of routine nursing, implementation of systematic SM nursing intervention for 8 weeks, the specific content is as follows: (1) The intervention group was established.
(2) Baseline assessment and file establishment (within 24 hours of admission).(3)
Implementation of core intervention (1st to 8th week).
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On the basis of routine nursing, implementation of systematic SM nursing intervention for 8 weeks, the specific content is as follows: (1) The intervention group was established.
(2) Baseline assessment and file establishment (within 24 hours of admission).(3)
Implementation of core intervention (1st to 8th week).
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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 Quality of Life as measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale
Prazo: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
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The Functional Assessment of Cancer Therapy-Lung (FACT-L) scale will be used to assess changes in quality of life in patients with advanced lung cancer.
The scale consists of 36 items across five domains: physical health status, social and family conditions, emotional well-being, functional capability, and lung cancer-specific supplementary concerns.
Each item is scored on a 0-4 Likert scale, with total scores ranging from 0 to 144.
Higher scores indicate better quality of life.
The scale has demonstrated good reliability and validity in Chinese populations (Cronbach's α = 0.88-0.92).
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Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Self-Management Efficacy as measured by the Strategies Used by People to Promote Health (SUPPH) Scale
Prazo: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
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The SUPPH scale will be used to assess changes in disease self-management efficacy.
The scale includes 28 items across three dimensions: Positive Attitude, Self-Applied Stress Reduction, and Independent Decision-Making.
Each item is scored on a 1-5 Likert scale, with total scores ranging from 28 to 140.
Higher scores indicate greater self-management efficacy.
The Chinese version has excellent reliability (Cronbach's α = 0.96 for the total scale).
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Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
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Change in Psychological Resilience as measured by the Connor-Davidson Resilience Scale (CD-RISC)
Prazo: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
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The CD-RISC will be used to assess changes in psychological resilience.
The scale measures three dimensions-Tenacity, Self-Improvement, and Optimism-using 25 items.
Each item is rated on a 0-4 scale, with total scores ranging from 0 to 100.
Higher scores indicate stronger psychological resilience.
The Chinese version has demonstrated good reliability (Cronbach's α = 0.91).
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Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mediating Effect of Self-Management Efficacy on the Relationship between Symptom Management Intervention and Quality of Life
Prazo: Assessed at 8 weeks (post-intervention) using post-intervention scores
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This outcome will examine whether self-management efficacy (SUPPH score) mediates the relationship between the symptom management nursing intervention (group assignment) and quality of life (FACT-L score).
The mediating effect will be analyzed using the PROCESS macro with bootstrap resampling (5,000 iterations).
Indirect effect, direct effect, and total effect will be calculated with 95% confidence intervals.
An effect is considered significant if the 95% CI does not include zero.
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Assessed at 8 weeks (post-intervention) using post-intervention scores
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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)
10 de junho de 2023
Conclusão Primária (Real)
27 de outubro de 2024
Conclusão do estudo (Real)
12 de dezembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
25 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de junho de 2026
Primeira postagem (Real)
1 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 20230509
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
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