Research on the Development and Validation of Personalized Exercise Prescriptions for Breast Cancer Patients Based on Large Language Models

NCT07619781 | Active Not Recruiting

• 1 other identifier: SYSKY-2025-786-01
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

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.

  From enrollment to completion of prescription evaluation at 1 week

Secondary Outcomes (1)

• Evaluation Form for Consistency Between Model Diagnostic Logic and Medical Consensus

  From enrollment to completion of prescription evaluation at 1 week

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: June 2, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-06

Locations

CN (1)