- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07827183
AI-Personalized Discharge Education for Patients After Lung Cancer Surgery (AI-LUNG)
Effect of AI-Personalized Discharge Education on the Quality of Discharge Teaching and Recovery Outcomes in Patients After Lung Cancer Surgery: A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a single-center, prospective, single-blind randomized controlled trial designed to evaluate whether AI-personalized discharge education can improve discharge teaching quality and postoperative recovery outcomes among patients undergoing surgery for lung cancer. A total of 156 eligible participants will be randomly assigned in a 1:1 ratio to an intervention group or a control group.
Participants in the control group will receive routine discharge care, including verbal education provided by nursing staff and a standardized printed discharge education booklet covering medication use, wound care, respiratory exercises, physical activity, diet, follow-up, and other routine postoperative care.
Participants in the intervention group will receive routine discharge care plus AI-personalized discharge education. Within 24 hours before discharge, relevant patient information will be entered into a structured system, including surgical approach, extent of lung resection, pain score, dyspnea score, comorbidities, discharge medications, home care conditions, educational level, smoking history, and postoperative complications. A large language model will then generate an individualized discharge guidance document. The guidance will include medication instructions, respiratory rehabilitation exercises, wound and activity management, follow-up planning, and warning signs requiring medical attention. All AI-generated content will be reviewed and approved by a responsible nurse before being delivered to the participant or caregiver.
The primary outcome is discharge teaching quality, assessed using the Quality of Discharge Teaching Scale (QDTS) on the day of discharge after the intervention. Secondary outcomes include self-efficacy for postoperative rehabilitation management, assessed using the SESPRM-LC scale, and quality of life, assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L) scale, both measured one month after discharge.
The study will also explore the relationships among discharge teaching quality, self-efficacy, and quality of life, including the potential mediating role of self-efficacy.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Weiguang Zhou, Master's
- Número de teléfono: +86 13624449503
- Correo electrónico: 254402969@qq.com
Ubicaciones de estudio
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Jilin
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Siping, Jilin, Porcelana, 136000
- Reclutamiento
- Siping Central People's Hospital
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Investigador principal:
- Yang Liu, PhD
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Contacto:
- Weiguang Zhou, Master's
- Número de teléfono: +86 13624449503
- Correo electrónico: 254402969@qq.com
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Pathologically confirmed primary lung cancer and underwent radical lung cancer surgery by thoracoscopic or open approach, including lobectomy, pneumonectomy, or wedge resection.
- Age 18 to 80 years.
- Clinical stage I to III.
- No distant organ metastasis.
- Clinically stable after surgery, conscious, and able to perform basic listening, speaking, and reading activities, with planned discharge to home for recovery.
- The participant or primary caregiver is able to use a smartphone and WeChat.
- Able and willing to provide informed consent and voluntarily participate in the study.
Exclusion Criteria:
- Recurrent lung cancer or previous treatment with targeted therapy, chemotherapy, or radiotherapy.
- Severe aphasia, cognitive impairment (MMSE <24), or psychiatric disorders that prevent independent completion of study questionnaires.
- Severe cardiac, hepatic, or renal dysfunction, or another malignant tumor.
- Severe postoperative complications requiring prolonged hospitalization, such as bronchopleural fistula or major bleeding.
- Participation in another interventional clinical study.
- Unable to complete the 1-month follow-up because of travel or residence outside the study area after discharge.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: AI-Personalized Discharge Education
Participants receive routine discharge education plus AI-personalized discharge guidance.
The personalized guidance is generated based on individual clinical and care-related information and is reviewed by a responsible nurse before being provided to the participant or caregiver.
|
Participants receive an individualized discharge guidance plan generated by an artificial intelligence system based on clinical and care-related information, including surgical approach, extent of lung resection, pain and dyspnea scores, comorbidities, discharge medications, home care conditions, educational level, smoking history, and postoperative complications.
The guidance includes medication instructions, respiratory exercises, wound and activity management, follow-up planning, and warning signs requiring medical attention.
All AI-generated content is reviewed by a responsible nurse before being provided to the participant or caregiver.
Participants receive routine discharge education provided by nursing staff, including verbal instructions and a standardized printed discharge booklet covering medication use, wound care, respiratory exercises, physical activity, diet, follow-up, and other routine postoperative care.
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|
Comparador activo: Routine Discharge Education
Participants receive routine discharge education, including verbal instructions from nursing staff and a standardized printed discharge education booklet covering medication use, wound care, respiratory exercises, physical activity, diet, follow-up, and related postoperative care.
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Participants receive routine discharge education provided by nursing staff, including verbal instructions and a standardized printed discharge booklet covering medication use, wound care, respiratory exercises, physical activity, diet, follow-up, and other routine postoperative care.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of Discharge Teaching Scale (QDTS) Total Score
Periodo de tiempo: On the day of discharge, immediately after the intervention
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Discharge teaching quality will be assessed using the Quality of Discharge Teaching Scale (QDTS).
The QDTS contains 24 items scored from 0 to 10, with a total score ranging from 0 to 240.
Higher scores indicate better quality of discharge teaching.
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On the day of discharge, immediately after the intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Self-Efficacy for Postoperative Rehabilitation Management (SESPRM-LC) Total Score
Periodo de tiempo: 1 month after discharge
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Self-efficacy for postoperative rehabilitation management will be assessed using the SESPRM-LC scale.
The scale contains 27 items scored from 1 to 5, with a total score ranging from 27 to 135.
Higher scores indicate greater self-efficacy.
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1 month after discharge
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Quality of Life Measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L)
Periodo de tiempo: 1 month after discharge
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Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L).
Higher scores indicate better quality of life.
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1 month after discharge
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yang Liu, PhD, Xiamen University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AI-LUNG-RCT-2026-01
- SKJT2026-003 (Otro identificador: Ethics Committee of Siping Central People's Hospital)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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