Chatbot Utilization for Pedigree Creation and Cancer Risk Assessment in Cancer Genetic Counseling

NCT07887620 | Not Yet Recruiting

• 1 other identifier: I-4840126
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hereditary Breast Carcinoma; Hereditary Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 21 days before genetics appointment

Secondary Outcomes (4)

• Accuracy of chatbot generated family history pedigree

  Up to 21 days before genetics appointment

• chatbot generated Tyrer Cuzick determination of breast cancer risk

  Up to 21 days before genetics appointment

• Proportion of patients with greater than 20% lifetime breast cancer risk

  Up to 21 days before genetics appointment

• Patient satisfaction survey with using a chatbot

  Up to 7 days after genetics appointment

Study Arms (1)

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.

Other: Text Message -based Navigation Intervenion; Other: Artificial Intelligence based Intervention

Interventions

Text Message -based Navigation Intervenion OTHER

Receive chatbot phone number text message

Screening - chatbox call

Artificial Intelligence based Intervention OTHER

Complete chatbot phone call

Screening - chatbox call

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Breast Cancer, Familial

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Locations

US (1)