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Recruiting NCT06981208

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

No phase Interventional Breast Cancer Cancer of the Breast

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ChatGPT-generated patient education, Usual patient education.
Who it may be relevant to
Registry conditions: Breast Cancer, Cancer of the Breast. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other 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.
  • 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.

Primary outcome measures

  • Patient perceived understanding of breast reconstruction [Time frame: Pre-surgical consultation (day 1)]
Secondary outcome measures (5)
  • Patient satisfaction with education regarding breast reconstruction [Time frame: Pre-surgical consultation (day 1)]
  • Surgeon satisfaction with the consultation process [Time frame: Pre-surgical consultation (day 1)]
  • Surgeon perception of patient preparedness [Time frame: Pre-surgical consultation (day 1)]
  • Surgeon views on the efficiency of the consultation [Time frame: Pre-surgical consultation (day 1)]
  • Surgeon overall experience with the consultation [Time frame: Pre-surgical consultation (day 1)]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Identifiers

NCT: NCT06981208 · 202505097

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗