ChatGPT Education for Breast Reconstruction in Breast Cancer

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

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Non-English speakers, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

410 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

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

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for patients scheduled for breast reconstruction consultation after breast cancer. There are no specific inclusion or exclusion criteria provided, so it appears open to all individuals preparing for this type of surgery who are willing to participate in the study surveys.

Inclusion Criteria

Can speak and understand English

I have an appointment for breast reconstruction consultation at Washington University after mastectomy.

Exclusion Criteria

Not meeting the surgeon eligibility criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-consultation

Patients receive either ChatGPT-generated or usual patient education prior to their consultation

1 day

1 visit (in-person)

Consultation

In-person consultation with the plastic surgeon, followed by patient and surgeon surveys

1 day

1 visit (in-person)

Follow-up

Participants are monitored for satisfaction and understanding through surveys

1-2 weeks

Treatment Details

Interventions

• ChatGPT-generated patient education

Trial Overview The study compares two types of patient education before a surgical consult: one using ChatGPT-generated materials and the other using standard educational methods. Patients' satisfaction with their consultations will be measured through surveys, as will surgeons' opinions on the utility of ChatGPT information.

Participant Groups

Group I: ChatGPT-generated patient education Experimental Treatment 1 Intervention

* 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.

Group II: Usual education Active Control 1 Intervention

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

Group III: Surgeons Active Control 1 Intervention

* 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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+