Clinical trial NCT06981208: ChatGPT & Surgeon Synergy: Redefining Breast Reconstruction Consultations for Enhanced Patient Engagement and Satisfaction
Official title: ChatGPT & Surgeon Synergy: Redefining Breast Reconstruction Consultations for Enhanced Patient Engagement and Satisfaction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Cancer of the Breast
Keywords: Patient education
ChatGPT
Breast reconstruction
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Patient perceived understanding of breast reconstruction
timeFrame: Pre-surgical consultation (day 1)
Secondary outcomes:
measure: Patient satisfaction with education regarding breast reconstruction
timeFrame: Pre-surgical consultation (day 1)
measure: Surgeon satisfaction with the consultation process
timeFrame: Pre-surgical consultation (day 1)
measure: Surgeon perception of patient preparedness
timeFrame: Pre-surgical consultation (day 1)
measure: Surgeon views on the efficiency of the consultation
timeFrame: Pre-surgical consultation (day 1)
measure: Surgeon overall experience with the consultation
timeFrame: Pre-surgical consultation (day 1)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Saif M Badran, M.D., Ph.D., FRCS
role: PRINCIPAL_INVESTIGATOR
References: