- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07767565
Research on the Development and Validation of Personalized Exercise Prescription System for Breast Cancer Patients Based on Large Language Models
The goal of this observational study is to develop and evaluate a large language model (LLM)-based decision support system for exercise prescription in breast cancer patients, aiming to provide personalized decision-making support for postoperative breast cancer rehabilitation.
The main questions it aims to answer are:
How accurate, personalized, and safe are the exercise prescriptions generated by the fine-tuned LLM? How does the model's performance compare with other mainstream or non-fine-tuned models across different stages and subtypes of breast cancer? Participants are postoperative breast cancer rehabilitation patients treated at Sun Yat-sen Memorial Hospital of Sun Yat-sen University. They will have demographic, tumor, treatment, and physical fitness data collected; receive personalized exercise prescriptions automatically generated by the LLM-based system; and provide subjective evaluations on the feasibility and executability of the prescriptions.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Luoghi di studio
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Guangdong
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Guangzhou, Guangdong, Cina, 510000
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Contatto:
- jianli Zhao
- Numero di telefono: 15920589334
- Email: zhaojianli1988@126.com
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Contatto:
- Email: zhaojianli1988@126.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Adult patients aged 18-75 years with early-stage breast cancer who have undergone surgical treatment, such as mastectomy or breast-conserving surgery.
- The patients had clear clinical diagnosis and complete electronic medical record information (including demographic information, tumor stage and classification, treatment history, physical performance evaluation data, etc.).
Exclusion Criteria:
- Presence of severe postoperative complications or comorbidities (e.g., uncontrolled cardiac or pulmonary disease) that may interfere with participation in rehabilitation or pose a safety risk.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Postoperative breast cancer patients receiving LLM-based exercise prescription evaluation
Postoperative breast cancer patients at Sun Yat-sen Memorial Hospital will have clinical and physical data collected.
Each patient receives an exercise prescription generated by a fine-tuned large language model (LLM)-based decision support system and provides feedback on its feasibility.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Overall Quality Score of Exercise Prescriptions Based on a Five-Dimensional Expert Evaluation Framework
Lasso di tempo: From enrollment to completion of prescription evaluation at 1 week
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Each exercise prescription will be independently evaluated by six multidisciplinary experts across five dimensions: scientific rationale, personalization, comprehensiveness, safety, and feasibility.
Each dimension will be rated on a 5-point Likert scale from 1 to 5. The five dimension scores will be summed to generate an overall quality score ranging from 5 to 25, with higher scores indicating better overall prescription quality.
For each prescription, the mean overall score across the six experts will be used for analysis.
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From enrollment to completion of prescription evaluation at 1 week
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Subgroup-Specific Scientific Rationale and Safety Scores of Model-Generated Exercise Prescriptions
Lasso di tempo: From enrollment to completion of prescription evaluation at 1 week
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Model performance will be evaluated across predefined subgroups based on age, breast cancer stage, molecular subtype, surgical procedure, and treatment modality.
Scientific rationale and safety will each be rated on a 1-5 Likert scale, with higher scores indicating better performance.
Differences across models and subgroups will be assessed using two-way ANOVA or generalized linear models, including interaction terms between model type and patient characteristics.
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From enrollment to completion of prescription evaluation at 1 week
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SYSKY-2025-786-02
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .