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NCT Number: NCT07619781

Research on the Development and Validation of Personalized Exercise Prescriptions 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • ECOG performance status of 0-1, with adequate physical condition to participate in rehabilitation assessment and exercise prescription activities.
  • Availability of essential clinical data, including demographic characteristics, tumor stage and subtype, treatment history, and baseline physical fitness assessment.
  • Able to communicate effectively, maintain stable follow-up contact, and voluntarily participate in evaluation and feedback on exercise prescriptions.

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.
  • Significant physical or mobility impairments preventing the performance of prescribed exercises.
  • Severe psychiatric illness or cognitive dysfunction that hinders cooperation with assessments or follow-up.
  • Incomplete or missing key clinical data, making evaluation or follow-up impossible.
  • Any other condition deemed inappropriate for participation by the investigators.

Treatment and study plan

Primary outcomes

  1. Average 5-point Likert scores across five expert-defined dimensions-individualization, comprehensiveness, scientific rationality, safety, and executability-are used to compare the performance of fine-tuned models with that of mid-level physicians.

    Time frame: From enrollment to completion of prescription evaluation at 1 week

Secondary outcomes

  1. Evaluation Form for Consistency Between Model Diagnostic Logic and Medical Consensus

    Time frame: From enrollment to completion of prescription evaluation at 1 week

    Measurement Method/Unit: A panel of expert reviewers (at least 3 senior physicians) conducts a blinded assessment of the model's diagnostic reasoning pathways in test cases using a dedicated evaluation form. The outcome is expressed as the mean score (points).

    Rating Scale: 5-point Likert scale (1=Highly Unsound, 5=Highly Sound)

    Interpretation of Scores: A higher score indicates better consistency of the model's diagnostic logic with established medical consensus.

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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