Brief Summary

This phase III trial compares the use of a digital chatbot enabled intervention to standard remote genetic services for increasing uptake of genetic counseling and testing among adolescents and young adult (AYA) cancer patients. Genetic testing for cancer predisposition syndromes has become standard evidence-based practice and can inform enhanced screening and risk reducing measures to reduce cancer morbidity and mortality. Despite this, many AYAs are not receiving recommended genetic counseling and testing. Offering remote telehealth services can address access barriers and chatbots and texting interventions could enhance patient outcomes and reduce provider and staff time. The use of a digital chatbot enabled intervention may be equally as effective as standard remote genetic services in AYA cancer patients undergoing genetic testing.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

535

participants targeted

Target at P75+ for not_applicable

Timeline

36mo left

Started Dec 2025

Longer than P75 for not_applicable

Geographic Reach

1 country

215 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.4 years study duration

Study Progress12%

Dec 2025Apr 2029

First Submitted

Initial submission to the registry

June 24, 2025

Completed

1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed

4 months until next milestone

Study Start

First participant enrolled

December 10, 2025

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2028

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

June 24, 2025

Last Update Submit

March 2, 2026

Conditions

Miscellaneous Neoplasm, Nos Non-Neoplastic Condition, Nos

Outcome Measures

Primary Outcomes (2)

Uptake of genetic counseling
Defined as a binary outcome of whether an adolescent or young adult (AYA) underwent genetic counseling within 6 months post completion of the baseline survey. Will be compared between randomized arms using Cochran-Mantel-Haenszel (CMH) tests stratified by gender and a Bonferroni correction will be applied to control family-wise type I error.
Within 6 months of baseline
Uptake of genetic testing
Defined as a binary outcome of whether an AYA underwent genetic testing within 6 months post completion of the baseline survey. Will be compared between randomized arms using CMH tests stratified by gender and a Bonferroni correction will be applied to control family-wise type I error.
Within 6 months of baseline

Secondary Outcomes (15)

Knowledge of genetic disease
Up to 42 months post registration
Test result recall
Up to 42 months post registration
Perceptions of genetic disease
Up to 42 months post registration
Anxiety
Up to 42 months post registration
Depression
Up to 42 months post registration
+10 more secondary outcomes

Study Arms (2)

Arm I (standard remote genetic services)

ACTIVE COMPARATOR

Patients attend a standard of care telehealth visit with a genetic counselor for pretest genetic education. Patients then undergo standard of care genetic testing and attend a telehealth visit with a genetic counselor for disclosure of results.

Other: TelemedicineOther: Genetic TestingOther: Survey Administration

Arm II (Genetic Journey Chatbot)

EXPERIMENTAL

Patients receive access to the Genetic Journey Chatbot and choose to complete digital pre-test genetic education via the digital tool or via telehealth visit with a genetic counselor. Via the chatbot, patients may request a telehealth visit with a genetic counselor at any time to answer unresolved questions. Patients then undergo standard of care genetic testing and attend a telehealth visit with a genetic counselor for disclosure of results. The chatbot remains available to answer questions, assess barriers, and provide reminders for next steps during the testing period.

Other: TelemedicineOther: Genetic TestingOther: Internet-Based InterventionOther: Educational InterventionBehavioral: Patient NavigationOther: InterviewOther: Survey Administration

Interventions

TelemedicineOTHER

Undergo telehealth visit with genetic counselor for pretest genetic education

Arm I (standard remote genetic services)Arm II (Genetic Journey Chatbot)

Genetic TestingOTHER

Complete standard of care genetic testing

Arm I (standard remote genetic services)Arm II (Genetic Journey Chatbot)

Internet-Based InterventionOTHER

Receive access to Genetic Journey Chatbot

Arm II (Genetic Journey Chatbot)

Educational InterventionOTHER

Complete digital pre-test genetic education

Arm II (Genetic Journey Chatbot)

Patient NavigationBEHAVIORAL

Utilize chatbot to answer questions, assess barriers, and provide reminders for next steps during the testing period

Arm II (Genetic Journey Chatbot)

InterviewOTHER

Complete interview

Arm II (Genetic Journey Chatbot)

Survey AdministrationOTHER

Ancillary studies

Arm I (standard remote genetic services)Arm II (Genetic Journey Chatbot)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

* PATIENTS: Age ≥ 18 years and ≤ 39 years at the time of enrollment * PATIENTS: AYA cancer patients and survivors. This includes patients at any stage of diagnosis (e.g., newly diagnosed, in treatment, in survivorship) and a cancer diagnosis (including pediatric cancers) at any age ≤ 39 years old. Given targeted therapies for BRCA+ and microsatellite instability (MSI)-high/Lynch Syndrome patients and benefit to relatives, patients with metastatic cancer are included. Any history of cancer, regardless of being in treatment or not * PATIENTS: Language: In order to complete the mandatory patient-completed measures and receive genetic education and counseling, participants must be able to speak and read English or Spanish * PATIENTS: No known diagnosis of dementia or cognitive impairment. Persons with impaired decision-making capacity are ineligible as they need to be able to understand genetic test results, its implications for the patient and family, and explain genetic test results to their family members * PATIENTS: No persons with a known psychiatric or documented developmental disorder that affects cognitive or emotional functions to the extent that the capacity for judgment and reason is significantly diminished, such that they cannot participate based on the judgment of the treating physician * PATIENTS: Participants must meet National Comprehensive Cancer Network (NCCN) guidelines for genetic testing assessment provided by Penn Telegenetics by the Eligibility Verification Assessment (EVA) chatbot, or paper forms and genetic counselor's review * NON-PATIENT PARTICIPANT: Non-patient participants eligible for this study include: oncology providers, members of the care team and clinic staff, genetic counselors, and insurers (i.e., people who work in financial services and/or for insurance companies) who participate in oncology care among AYA in community for this study * NON-PATIENT PARTICIPANT: Age ≥ 18 years * NON-PATIENT PARTICIPANT: Non-patient participants must be able to speak and read English or Spanish in order to participate in the key informant interviews

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (215)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

RECRUITING

Alaska Breast Care and Surgery LLC