Breast CancerNCT06981208
ChatGPT & Surgeon Synergy: Redefining Breast Reconstruction Consultations for Enhanced Patient Engagement and Satisfaction
A study testing ChatGPT or Google Gemini generated patient education and Usual patient education in people with Breast Cancer and Cancer of the Breast, run by Washington University School of Medicine at 1 site in United States.
Trial summary
In this study, patients who are scheduled for breast reconstruction consultation will be randomized into the intervention group (ChatGPT or Google Gemini generated patient education regarding possible reconstruction options) or the control group (usual patient education). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Cancer of the Breast
- What is being tested?
- ChatGPT or Google Gemini generated patient education and Usual patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Saif M Badran, M.D., Ph.D., FRCS, 314-273-1434, badran@wustl.edu
Saif M Badran, M.D., Ph.D., FRCS
About this study
In this study, patients who are scheduled for breast reconstruction consultation will be randomized into the intervention group (ChatGPT or Google Gemini 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 or Google Gemini 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.
- Conditions
- Breast Cancer, Cancer of the Breast
- Being tested
- ChatGPT or Google Gemini generated patient education, Usual patient education
- Keywords
- Patient education, ChatGPT, Breast reconstruction, Google Gemini
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatGPT or Google Gemini generated patient educationOther
This is created by entering the patient's age, medical history, social history, and case-specific details into Washington University ChatGPT Beta or Google Gemini (HIPAA and FERPA compliant) by a study team member.
Usual patient educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ChatGPT or Google Gemini generated patient education | Experimental | * Pre-consultation ChatGPT or Google Gemini patient education: The patients randomized into the ChatGPT or Google Gemini education group will receive a ChatGPT or Google Gemini patient education on paper prior to their consultation. The ChatGPT or Google Gemini 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. Receives: Other: ChatGPT or Google Gemini generated patient education |
| Usual education | Active comparator | - Patients will not receive any additional information prior to their consultation. Receives: Other: Usual patient education |
| Surgeons | No intervention | * In order for the surgeon to be blinded to the study arm, all participants will have ChatGPT or Google Gemini 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 or Google Gemini 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient perceived understanding of breast reconstruction
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.
Measured: Pre-surgical consultation (day 1)
Secondary outcomes (5)
Patient satisfaction with education regarding breast reconstruction
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.
Measured: Pre-surgical consultation (day 1)
Surgeon satisfaction with the consultation process
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.
Measured: Pre-surgical consultation (day 1)
Surgeon perception of patient preparedness
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.
Measured: Pre-surgical consultation (day 1)
Surgeon views on the efficiency of the consultation
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.
Measured: Pre-surgical consultation (day 1)
Surgeon overall experience with the consultation
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.
Measured: Pre-surgical consultation (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start3 Jun 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saif M Badran, M.D., Ph.D., FRCS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981208
- Sponsor's protocol ID
- 202505097
- Status last verified
- Oct 2026
- First submitted
- 12 May 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ChatGPT & Surgeon Synergy: Redefining Breast Reconstruction Consultations for Enhanced Patient Engagement and Satisfaction
- ClinicalTrials.gov ID
- NCT06981208
- Acronym / sponsor ID
- 202505097
- Conditions
- Breast Cancer, Cancer of the Breast
- Keywords
- Patient education, ChatGPT, Breast reconstruction, Google Gemini
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, patients who are scheduled for breast reconstruction consultation will be randomized into the intervention group (ChatGPT or Google Gemini 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 or Google Gemini 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ChatGPT or Google Gemini generated patient education | Experimental | Other: ChatGPT or Google Gemini generated patient education* Pre-consultation ChatGPT or Google Gemini patient education: The patients randomized into the ChatGPT or Google Gemini education group will receive a ChatGPT or Google Gemini patient education on paper prior to their consultation. The ChatGPT or Google Gemini 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. |
| Usual education | Active comparator | Other: Usual patient education- Patients will not receive any additional information prior to their consultation. |
| Surgeons | No intervention | –* In order for the surgeon to be blinded to the study arm, all participants will have ChatGPT or Google Gemini 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 or Google Gemini 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChatGPT or Google Gemini generated patient educationThis is created by entering the patient's age, medical history, social history, and case-specific details into Washington University ChatGPT Beta or Google Gemini (HIPAA and FERPA compliant) by a study team member. | Other | ChatGPT or Google Gemini generated patient education |
| Usual patient educationUsual 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. | Other | Usual education |
Primary outcome
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.
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saif M Badran, M.D., Ph.D., FRCS principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ChatGPT or Google Gemini generated patient education and Usual patient education in people with Breast Cancer and Cancer of the Breast, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saif M Badran, M.D., Ph.D., FRCS (314-273-1434, badran@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient perceived understanding of breast reconstruction (time frame: Pre-surgical consultation (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.