此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

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.

研究概览

地位

尚未招聘

研究类型

观察性的

注册 (估计的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients with breast cancer who have completed primary surgery and entered the postoperative rehabilitation stage at Sun Yat-sen Memorial Hospital, Sun Yat-sen University (Guangzhou, China).All participants receive individualized exercise prescriptions generated by large language models under physician supervision and approval, and their feedback on the feasibility of these prescriptions is collected.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Overall Quality Score of Exercise Prescriptions Based on a Five-Dimensional Expert Evaluation Framework
大体时间:From enrollment to completion of prescription evaluation at 1 week
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.
From enrollment to completion of prescription evaluation at 1 week

次要结果测量

结果测量
措施说明
大体时间
Subgroup-Specific Scientific Rationale and Safety Scores of Model-Generated Exercise Prescriptions
大体时间:From enrollment to completion of prescription evaluation at 1 week
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.
From enrollment to completion of prescription evaluation at 1 week

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月15日

初级完成 (估计的)

2027年7月1日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年8月11日

首先提交符合 QC 标准的

2026年8月11日

首次发布 (实际的)

2026年8月17日

研究记录更新

最后更新发布 (实际的)

2026年8月17日

上次提交的符合 QC 标准的更新

2026年8月11日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • SYSKY-2025-786-02

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅