Hereditary Breast CarcinomaNCT07887620
Chatbot Utilization for Pedigree Creation and Cancer Risk Assessment in Cancer Genetic Counseling
A study testing Text Message -based Navigation Intervenion and Artificial Intelligence based Intervention in people with Hereditary Breast Carcinoma and Hereditary Malignant Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This clinical trial studies whether a chatbot can be used to help collect medical history and perform cancer risk assessment among patients undergoing cancer genetic counseling. With the improved cost of genetic testing and growing utilization of genetics in cancer care and risk assessment, there is growing pressure… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hereditary Breast Carcinoma, Hereditary Malignant Neoplasm
- What is being tested?
- Text Message -based Navigation Intervenion and Artificial Intelligence based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Nov 2027
- Phase
- Interventional
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENT PARTICIPANTS: Age 18 years or greater
- PATIENT PARTICIPANTS: Scheduled as a new patient appointment to see a certified genetic counselor at the Roswell Park Comprehensive Cancer Center (either in person or for a virtual appointment)
- PATIENT PARTICIPANTS: Written and spoken fluency in English
- PATIENT PARTICIPANTS: Able to understand the consenting process and willing to participate in the study
- GENETIC COUNSELOR PARTICIPANTS: Any genetic counselor who sees patients for initial genetics consultation at Roswell Park Comprehensive Cancer Center is eligible to participate in the study
Who cannot join
- Prior germline genetic testing for a hereditary cancer predisposition
- First or second-degree family member with a known pathogenic variant, likely pathogenic variant, or variant of uncertain significance in a gene associated with cancer predisposition
- Scheduled to see a genetic counselor who has not give
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
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
ASK RPCI, 877-275-7724, AskRoswell@Roswellpark.org
About this study
This clinical trial studies whether a chatbot can be used to help collect medical history and perform cancer risk assessment among patients undergoing cancer genetic counseling. With the improved cost of genetic testing and growing utilization of genetics in cancer care and risk assessment, there is growing pressure placed on certified genetic counselors. To address this issue, many have turned to artificial intelligence (the branch of computer science that deals with writing computer programs that can solve problems creatively) for practical solutions to re-distribute the workload of certified genetic counselors. The chatbot in this trial uses artificial intelligence technology to analyze information provided by the patient during a phone call. The chatbot then generates a family history summary, family tree (pedigree), and cancer risk related assessments, which may help redistribute the workload for the certified genetic counselor and ultimately make genetic counseling more accessible. Using a chatbot may be helpful in collecting medical history and determining cancer risk assessment among patients undergoing cancer genetic counseling.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the sensitivity and specificity of a chatbot's determination of meeting National Comprehensive Cancer Network (NCCN) criteria for germline genetic testing compared to a certified genetic counselor's determination
SECONDAY OBJECTIVES:
- To assess the reliability and accuracy of a chatbot-generated cancer-focused family pedigree as determined by a certified genetic counselor.
II. To determine the sensitivity and specificity of a chatbot-generated Tyrer-Cuzick determination of breast cancer risk.
III. To evaluate the proportion of patients in a genetic counseling clinic population with greater than 20% lifetime risk of breast cancer and/or criteria met for germline genetic testing.
IV. To evaluate patient satisfaction using a chatbot for family history collection and breast cancer risk assessment.
- To evaluate provider satisfaction with use, accuracy, and clinical workflow of chatbot-derived data.
OUTLINE:
Patients receive a text message with chatbot phone number at baseline. Patients then complete a phone call with the chatbot over 10-20 minutes consisting of a structured, genetics-specific interview and receive a chatbot generated provider summary, pedigree/structured data, NCCN flag, and Tyler-Cuzick score, which are routed to clinical team up to 21 days before scheduled genetics appointment.
- Being tested
- Text Message -based Navigation Intervenion, Artificial Intelligence based Intervention
- Medical subject headings
- Breast Cancer, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message -based Navigation IntervenionOther
Receive chatbot phone number text message
Artificial Intelligence based InterventionOther
Complete chatbot phone call
| Study group | Role | What they receive |
|---|---|---|
| Screening - chatbox call | Experimental | Patients receive a text message with chatbot phone number at baseline. Patients then complete a phone call with the chatbot over 10-20 minutes consisting of a structured, genetics-specific interview and receive a chatbot generated provider summary, pedigree/structured data, NCCN flag, and Tyler-Cuzick score, which are routed to clinical team up to 21 days before scheduled genetics appointment. Receives: Other: Text Message -based Navigation Intervenion; Other: Artificial Intelligence based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of chatbot in determining if patient meets National Comprehensive Cancer Network (NCCN) criteria for germline genetic testing
Will assess the sensitivity of a chatbot in determining if a patient meets NCCN criteria for germline genetic testing compared to the gold standard of a certified genetic counselor's (CGC's) determination
Measured: Up to 21 days before genetics appointment
Secondary outcomes (4)
Accuracy of chatbot generated family history pedigree
Graded by a CGC on a five point scale with 1 = entirely unreliable to 5 = no clinically meaning full errors.
Measured: Up to 21 days before genetics appointment
chatbot generated Tyrer Cuzick determination of breast cancer risk
To assess chatbot's determination of whether patient's lifetime breast cancer risk is estimated at greater than 20% utilizing the Tyrer-Cuzick algorithm
Measured: Up to 21 days before genetics appointment
Proportion of patients with greater than 20% lifetime breast cancer risk
Assessed by the Tyrer-Cuzick model
Measured: Up to 21 days before genetics appointment
Patient satisfaction survey with using a chatbot
Self administered Patient survey assessing satisfaction of using chatbot with responses ranging from strongly agree to Strongly disagree
Measured: Up to 7 days after genetics appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Breast CarcinomaStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887620
- Sponsor's protocol ID
- I-4840126
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No