- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Weiguang Zhou, Master's
- Telefonnummer: +86 13624449503
- E-post: 254402969@qq.com
Studieorter
-
-
Jilin
-
Siping, Jilin, Kina, 136000
- Rekrytering
- Siping Central People's Hospital
-
Huvudutredare:
- Yang Liu, PhD
-
Kontakt:
- Weiguang Zhou, Master's
- Telefonnummer: +86 13624449503
- E-post: 254402969@qq.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Aktiv komparator: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quality of Discharge Teaching Scale (QDTS) Total Score
Tidsram: On the day of discharge, immediately after the intervention
|
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.
|
On the day of discharge, immediately after the intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Self-Efficacy for Postoperative Rehabilitation Management (SESPRM-LC) Total Score
Tidsram: 1 month after discharge
|
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.
|
1 month after discharge
|
|
Quality of Life Measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L)
Tidsram: 1 month after discharge
|
Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L).
Higher scores indicate better quality of life.
|
1 month after discharge
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Yang Liu, PhD, Xiamen University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AI-LUNG-RCT-2026-01
- SKJT2026-003 (Annan identifierare: Ethics Committee of Siping Central People's Hospital)
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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