An interventional study of ChatGPT-generated patient education and Usual patient education in Breast Cancer and Cancer of the Breast, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Health services research
In this study, patients who are scheduled for breast reconstruction consultation will be randomized into the intervention group (ChatGPT-generated patient education regarding possible reconstruction options) or the control group (usual patient education). All patients will complete a survey following their in-person consultation to assess their experience and overall satisfaction with the consultation process. Additionally, participating surgeons will complete a separate survey to evaluate their consultation experience, satisfaction, and to assess the accuracy and clinical utility of the ChatGPT-generated patient education materials. The surveys are designed to gather information on patient characteristics, organizational health literacy according to Brega et al. Other survey questions have been designed to meet the outcomes of this study and have not been based on previously published surveys.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 410 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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Patient Eligibility Criteria:
Surgeon Eligibility Criteria:
* Pre-consultation ChatGPT patient education: The patients randomized into the ChatGPT education group will receive a ChatGPT patient education on paper prior to their consultation. The ChatGPT will write a patient-tailored education regarding possible reconstruction options. The patient will review this independently, without additional input or guidance from a research team member * Patient post-consultation survey: All patients will receive a survey after the planned in-person consultation with the plastic surgeon.
Other: ChatGPT-generated patient education
\- Patients will not receive any additional information prior to their consultation.
Other: Usual patient education
* In order for the surgeon to be blinded to the study arm, all participants will have ChatGPT education created. Participating surgeons will review each patient education sheet prior to the consult and score the accuracy of the provided education sheet. The surgeon will proceed with the consultation as planned. The surgeon is blinded to the patient's study arm as they will be reviewing ChatGPT education for all patients. If any inaccuracies are identified in the patient education sheet, the surgeon will address this with the study team and have the errors fixed prior to providing to the patient. * The surgeon will receive a survey after each in-person consultation, covering patient experience, surgeon experience, and education material accuracy.
This is created by entering the patient's age, medical history, social history, and case-specific details into Washington University ChatGPT Beta (HIPAA and FERPA compliant) by a study team member.
Usual patient education will include description of breast reconstruction options, with further elaboration on which option are more suitable to the patient. This include also review of risk of complications and expected recovery after surgery.
Patient perceived understanding of breast reconstruction
The patient will choose an answer ranging from 0-100 (strongly disagree to strongly agree). The higher the score, the more perceived understanding the patient had.
Time frame: Pre-surgical consultation (day 1)
Patient satisfaction with education regarding breast reconstruction
The patient will choose an answer ranging from 0-100 (strongly disagree to strongly agree). The higher the score, the more satisfied the patient was.
Time frame: Pre-surgical consultation (day 1)
Surgeon satisfaction with the consultation process
Survey includes two question regarding surgeon's satisfaction with the consultation process. The surgeon will choose an answer ranging from 0-100 (strongly disagree to strongly agree). The higher the score, the more satisfied the surgeon was with the consultation process.
Time frame: Pre-surgical consultation (day 1)
Surgeon perception of patient preparedness
Survey includes one question regarding patient preparedness. The surgeon will choose an answer ranging from 0-100 (strongly disagree to strongly agree). The higher the score, the more prepared the surgeon felt the patient was.
Time frame: Pre-surgical consultation (day 1)
Surgeon views on the efficiency of the consultation
Survey includes one question regarding efficiency of the consultation. The surgeon will choose an answer ranging from 0-100 (strongly disagree to strongly agree). The higher the score, the more efficient the surgeon felt the consult was.
Time frame: Pre-surgical consultation (day 1)
Surgeon overall experience with the consultation
Survey includes one question regarding the pre-surgical consultation overall experience. The surgeon will choose an answer ranging from 0-100 (strongly disagree to strongly agree). The higher the score, the better the overall experience was.
Time frame: Pre-surgical consultation (day 1)
Plan to share: No
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