ChatGPT & Surgeon Synergy: Redefining Breast Reconstruction Consultations for Enhanced Patient Engagement and Satisfaction

NCT ID: NCT06981208

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-03

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Cancer of the Breast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers
The surgeons will be blinded to the patient's randomization arm prior to the in-person consultation.

Study Groups

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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.

Group Type EXPERIMENTAL

ChatGPT-generated patient education

Intervention Type OTHER

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 education

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

Group Type ACTIVE_COMPARATOR

Usual patient education

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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

Role: CONTACT

314-273-1434

Facility Contacts

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

Role: primary

314-273-1434

Related Links

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http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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202505097

Identifier Type: -

Identifier Source: org_study_id

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