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

NCT07767565 | Not Yet Recruiting DMC

• 1 other identifier: SYSKY-2025-786-02
• Study Type: observational
• Target: 40
• 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; Exercise and Recovery

Outcome Measures

Primary Outcomes (1)

• Overall Quality Score of Exercise Prescriptions Based on a Five-Dimensional Expert Evaluation Framework

  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

Secondary Outcomes (1)

• Subgroup-Specific Scientific Rationale and Safety Scores of Model-Generated Exercise Prescriptions

  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: all
• 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.
• 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.).

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.

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; Motor Activity

Condition Hierarchy (Ancestors)

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

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: August 11, 2026
• First Posted: August 17, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-08

Locations

CN (1)