Recruiting

ChatGPT Education

Sponsor:

Washington University School of Medicine

Code:

NCT06981208

Conditions

Breast Cancer

Cancer of the Breast

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ChatGPT-generated patient education

Usual patient education

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Cancer of the Breast

Study ID

NCT06981208

Start date

Jun 3, 2025

Status verified date

Jun, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Patient Eligibility Criteria:

  • Scheduled for initial preoperative breast reconstruction consultation following therapeutic or prophylactic mastectomy with a surgeon at Washington University School of Medicine.
  • At least 18 years of age.
  • Can speak and understand English.

Surgeon Eligibility Criteria:

  • Routinely performs breast reconstruction surgery at Washington University School of Medicine.
  • At least 18 years of age.
  • Can speak and understand English.
  • Surgeon must not be a resident or fellow at time of enrollment.

Study Design

Enrollment

410 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: ChatGPT-generated patient education

  • 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.

active comparator: Usual education

\- Patients will not receive any additional information prior to their consultation.

no intervention: Surgeons

  • 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.

Interventions

ChatGPT-generated patient education

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

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.

Primary outcome measure

  • Patient perceived understanding of breast reconstruction [ Time Frame: Pre-surgical consultation (day 1) ]

Central Contacts and Locations

Central contacts

Saif M Badran, M.D., Ph.D., FRCS

314-273-1434badran@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Saif M Badran, M.D., Ph.D., FRCS

314-273-1434badran@wustl.edu

Principal Investigator:

Saif M Badran, M.D., Ph.D., FRCS

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

  • Patient education
  • ChatGPT
  • Breast reconstruction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-06-10.