Clinical trial · Interventional
Effectiveness of AI Genetic Counseling Program vs In-person Genetic Counseling in Breast Cancer
A Randomized Trial Comparing the Effectiveness of Pre-test Genetic Counseling Using an Artificial Intelligence Program and Traditional In-person Genetic Counseling in Women Newly Diagnosed With Breast Cancer Who do Not Currently Meet National Comprehensive Cancer Network (NCCN) Criteria for Genetic Testing.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to help better understand the uptake and impact of genetic testing for women diagnosed with breast cancer who do not meet National Comprehensive Cancer Network (NCCN) criteria for genetic testing. By doing so, the research team will gain a better understanding of the clinical implications for offering genetic testing for all patients recently diagnosed with breast cancer versus only offering genetic testing to those meeting NCCN criteria. By offering genetic counseling and genetic testing to all women recently diagnosed with breast cancer, there will be a shortage of genetic counselors. This study will also assess the feasibility of using artificial intelligence to assist in the genetic counseling process.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Automated program (ChatBot) | Genetic | — | UNRESOLVED |
| BCGCKQ Survey | Other | — | UNRESOLVED |
| Genetics counselor | Genetic | — | UNRESOLVED |
| Genetic testing | Device | — | UNRESOLVED |
| Satisfaction Survey | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Artificial intelligence program
- description
- Will complete consult with the use of an artificial intelligence program Chatbot.
- interventionNames
- Genetic: Automated program (ChatBot)
- Other: BCGCKQ Survey
- Other: Satisfaction Survey
- Device: Genetic testing
- type
- ACTIVE_COMPARATOR
- label
- in-person genetic counseling
- description
- Will complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor
- interventionNames
- Genetic: Genetics counselor
- Other: BCGCKQ Survey
- Other: Satisfaction Survey
- Device: Genetic testing
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects diagnosed with Stage 0-3 breast cancer. * Patients who do not satisfy current NCCN criteria for referral to a genetics counselor and genetics testing. * Must have the ability to understand and the willingness to sign a written informed consent document as well as complete the study questionnaires. Exclusion Criteria: \- N/A
References
Publications (0)
Data not yet available