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 junio de 2026 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
176
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
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Porcelana, 200031
- Dahua Hospital, Xuhui District, Shanghai
-
-
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:
- 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.
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: 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.
|
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.
|
|
Otro: 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).
|
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).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Quality of Life as measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale
Periodo de tiempo: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
|
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).
|
Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Self-Management Efficacy as measured by the Strategies Used by People to Promote Health (SUPPH) Scale
Periodo de tiempo: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
|
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).
|
Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
|
|
Change in Psychological Resilience as measured by the Connor-Davidson Resilience Scale (CD-RISC)
Periodo de tiempo: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
|
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).
|
Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mediating Effect of Self-Management Efficacy on the Relationship between Symptom Management Intervention and Quality of Life
Periodo de tiempo: Assessed at 8 weeks (post-intervention) using post-intervention scores
|
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.
|
Assessed at 8 weeks (post-intervention) using post-intervention scores
|
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)
10 de junio de 2023
Finalización primaria (Actual)
27 de octubre de 2024
Finalización del estudio (Actual)
12 de diciembre de 2025
Fechas de registro del estudio
Enviado por primera vez
25 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de junio de 2026
Publicado por primera vez (Actual)
1 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 20230509
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
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .