Breast CancerNCT07619781
Research on the Development and Validation of Personalized Exercise Prescriptions for Breast Cancer Patients Based on Large Language Models
An observational study of Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 1 Jul 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to completion of prescription evaluation at 1 week
Secondary outcomes (1)
Evaluation Form for Consistency Between Model Diagnostic Logic and Medical Consensus
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.
Measured: From enrollment to completion of prescription evaluation at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Oct 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619781
- Sponsor's protocol ID
- SYSKY-2025-786-01
- Status last verified
- Jun 2026
- First submitted
- 25 Nov 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Development and Validation of Personalized Exercise Prescriptions for Breast Cancer Patients Based on Large Language Models
- ClinicalTrials.gov ID
- NCT07619781
- Acronym / sponsor ID
- SYSKY-2025-786-01
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Evaluation Form for Consistency Between Model Diagnostic Logic and Medical Consensus
Time frame: From enrollment to completion of prescription evaluation at 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.