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NCT Number: NCT06981208

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

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.

Recruiting

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cancer of the Breast Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Justin M Sacks, M.D., MBA, FACS

SUB_INVESTIGATOR

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

CONTACT

[email protected]

314-273-1434

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

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ChatGPT-generated patient education

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 patient education

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.

Primary outcomes

  1. Patient perceived understanding of breast reconstruction

    Time frame: Pre-surgical consultation (day 1)

    The patient will choose an answer ranging from 0-100 (strongly disagree to strongly agree). The higher the score, the more perceived understanding the patient had.

Secondary outcomes

  1. Patient satisfaction with education regarding breast reconstruction

    Time frame: Pre-surgical consultation (day 1)

    The patient will choose an answer ranging from 0-100 (strongly disagree to strongly agree). The higher the score, the more satisfied the patient was.

  2. Surgeon satisfaction with the consultation process

    Time frame: Pre-surgical consultation (day 1)

    Survey includes two question regarding surgeon's satisfaction with the consultation process. The surgeon will choose an answer ranging from 0-100 (strongly disagree to strongly agree). The higher the score, the more satisfied the surgeon was with the consultation process.

  3. Surgeon perception of patient preparedness

    Time frame: Pre-surgical consultation (day 1)

    Survey includes one question regarding patient preparedness. The surgeon will choose an answer ranging from 0-100 (strongly disagree to strongly agree). The higher the score, the more prepared the surgeon felt the patient was.

  4. Surgeon views on the efficiency of the consultation

    Time frame: Pre-surgical consultation (day 1)

    Survey includes one question regarding efficiency of the consultation. The surgeon will choose an answer ranging from 0-100 (strongly disagree to strongly agree). The higher the score, the more efficient the surgeon felt the consult was.

  5. Surgeon overall experience with the consultation

    Time frame: Pre-surgical consultation (day 1)

    Survey includes one question regarding the pre-surgical consultation overall experience. The surgeon will choose an answer ranging from 0-100 (strongly disagree to strongly agree). The higher the score, the better the overall experience was.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

314-273-1434

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 20, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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