- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07503054
Ovarian Cancer Screening and AI (AI-OCS-Gyn)
AI on Ovarian Cancer Screening Attitudes in Gynecologists
Study Overview
Status
Intervention / Treatment
Detailed Description
Previous research has demonstrated that gynecologists often substantially overestimate both the effectiveness and safety of ovarian cancer screening, despite robust evidence indicating that such screening does not offer a net clinical benefit. These findings highlight the need for innovative communication strategies to support evidence-based clinical practice and reduce low value care.
AI-based conversational interventions have shown promising results in other fields when aiming to correct misconceptions or encourage engagement with evidence, particularly among individuals who are initially resistant to factual information. Leveraging these insights, this study investigates whether AI-facilitated discussions can effectively improve gynecologists' knowledge of the benefit-harm profile of ovarian cancer screening and subsequently reduce non-evidence-based recommendations.
The study employs a cross-sectional study design in which gynecologists who have previously indicated to regularly recommend ovarian cancer screening with transvaginal ultrasound and potentially with additional CA 125-testing to their asymptomatic, average-risk patients are randomized to one of two conditions:
- Intervention Condition: Participants engage in an AI-guided conversation in which they explain their reasons for recommending ovarian cancer screening. The AI is instructed to address misconceptions and clarify the lack of evidence supporting a positive benefit-harm ratio.
- Control Condition: Participants engage in an AI discussion on the prevalence of ovarian cancer, without receiving information or corrective feedback related to screening outcomes.
Before and after the AI-based discussion, all participants are queried on their numerical (X out of 1,000 women) and subjective perception of ovarian cancer screening's benefits and harms and their screening recommendations. Measures are derived from instruments used in prior research.
The primary objective of this study is to assess the change, from before to after the AI-based conversation, in clinicians' understanding of the benefit-harm ratio and their recommendations regarding routine ovarian cancer screening for asymptomatic, average-risk women, within and between study groups.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Odette Wegwarth, Prof. Dr.
- Phone Number: +49 30 450 531 074
- Email: odette.wegwarth@charite.de
Study Contact Backup
- Name: Miriam K Rumpel, M.Sc.
- Phone Number: +49 30 450 531 058
- Email: miriam.rumpel@charite.de
Study Locations
-
-
State of Berlin
-
Mitte, State of Berlin, Germany, 10117
- Charité - Universitätsmedizin Berlin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- gynecologists in outpatient care who provide ovarian cancer screening to asymptomatic, average-risk women (not guideline consistent)
Exclusion Criteria:
- gynecologists in inpatient care
- gynecologist in outpatient care who do NOT provide ovarian cancer screening to asymptomatic, average-risk women (guideline consistent)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control (ChatGPT Control Condition)
Participants in this arm engage in a three-turn conversation with ChatGPT. The AI's role is to:
|
Three-turn conversation; discusses ovarian cancer risk and epidemiology; avoids screening topics; concise responses (5-8 sentences). Mode of Delivery: Online chat interface; participant interacts directly with ChatGPT. |
|
Experimental: Experimental (ChatGPT Evidence-Based Screening Discussion)
Participants in this arm engage in a three-turn conversation with ChatGPT. The AI's role is to:
|
Three-turn conversation; asks participants about screening rationale; provides evidence-based info on benefits/harms, trial data, guideline positions; concise responses (5-8 sentences). Mode of Delivery: Online chat interface; participant interacts directly with ChatGPT. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in intention to recommend ovarian cancer screening
Time Frame: Immediately post intervention
|
Difference in participants' self-reported frequency of recommending ovarian cancer screening to average-risk women in the future after the ChatGPT interaction and their self-reported frequency of recommending the screening in the past.
|
Immediately post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in benefit-harm ratio evaluation of ovarian cancer screenings
Time Frame: Immediately post intervention
|
Difference between the self-reported benefit-harm ratio evaluation before and after the ChatGPT interaction.
|
Immediately post intervention
|
|
Accuracy of knowledge regarding ovarian cancer screening evidence
Time Frame: Immediately post intervention
|
Participants' understanding of benefits, harms, and guideline recommendations for ovarian cancer screening, assessed via survey questions
|
Immediately post intervention
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Wegwarth O,Gigerenzer G
- Wegwarth O,Pashayan N
- US Preventive Services Task Force; Grossman DC, Curry SJ, Owens DK, Barry MJ, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW. Screening for Ovarian Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2018 Feb 13;319(6):588-594. doi: 10.1001/jama.2017.21926.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2025ChatGPTGyn
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cancer Screening Recommendations by Gynecologists
-
Karolinska InstitutetCompletedProstate Cancer | Prostate Cancer Screening | Prostate Cancer Screening Decision | Prostate Specific Antigen ScreeningSweden
-
Massachusetts General HospitalAgency for Healthcare Research and Quality (AHRQ)CompletedBreast Cancer Screening | Colon Cancer Screening | Prostate Cancer ScreeningUnited States
-
The First Affiliated Hospital of the Fourth Military...Active, not recruitingBreast Cancer | Ultrasound Imaging | Mass Screening | Cancer Screening | AI (Artificial Intelligence)China
-
Azienda Sanitaria Locale CN2 Alba-BraRecruitingBreast Cancer Screening | Breast Cancer Screening and DiagnosisItaly
-
Peking University Cancer Hospital & InstituteRecruitingGastric Cancer | Esophageal Cancer | Risk Stratification | Precision Screening | Sequential ScreeningChina
-
Bilecik Seyh Edebali UniversitesiActive, not recruitingColo-rectal Cancer | Colon Cancer Screening | Screening ColonscopyTurkey (Türkiye)
-
Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
-
University Hospital OlomoucRecruitingBreast Cancer Screening | Breast Cancer Screening and Diagnosis | Artificial Intelligence (AI)Czechia
-
Sunil PatelCompletedColonoscopy | Mass Screening | Colorectal Cancer ScreeningCanada
-
Harvard School of Public Health (HSPH)National Cancer Institute (NCI); National Institutes of Health (NIH)CompletedBreast Cancer Screening | Implementation | Colorectal Cancer ScreeningUnited States
Clinical Trials on ChatGPT - Control
-
Ankara UniversityNot yet recruitingHypertension | Artificial Intelligence | Nursing Students
-
Istituto Clinico HumanitasFondazione I.R.C.C.S. Istituto Neurologico Carlo BestaCompleted
-
Philipps University MarburgCompleted
-
Chang Gung University of Science and TechnologyNational Science and Technology Council, TaiwanNot yet recruitingSocial Communication | CHF - Congestive Heart Failure | 65 Years Older
-
Boston Intelligent Medical Research Center, Shenzhen...Tsinghua UniversityNot yet recruitingPreoperative Care
-
National Taiwan University HospitalEnrolling by invitationAutism | Job Interview PerformanceTaiwan
-
Chang Gung University of Science and TechnologyNot yet recruitingSocial Communication | CHF - Congestive Heart Failure | 65 Years Older | Sarcopenia in Elderly
-
Saglik Bilimleri UniversitesiCompleted
-
Lahore University of Management SciencesKing Edward Medical UniversityCompleted
-
Montefiore Medical CenterCompleted