NCT07091617

Testing an Enhanced Digital Delivery Model for Inherited Cancer Genetic Testing in Young Adults With Cancer

AYA Access Study: An Enhanced eHealth and Chat-Bot Enabled Delivery Model for Clinical Genetic Services in Community AYA Cancer Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 535 (estimated)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary and secondary objectives of the study: PRIMARY OBJECTIVES: I. To evaluate the efficacy of an enhanced eHealth and chatbot enabled delivery model to increase uptake of genetic counseling. II. To evaluate the efficacy of an enhanced eHealth and chatbot enabled delivery model to increase uptake of genetic testing. SECONDARY OBJECTIVE: I. To evaluate the efficacy of an enhanced eHealth and chatbot enabled delivery model to provide non-inferior short-term and longitudinal cognitive (e.g. knowledge), affective (e.g. distress), and behavioral outcomes (e.g. cancer screening and communication to relatives) and costs. EXPLORATORY OBJECTIVES: I. To test for moderators of uptake of counseling and testing (primary objectives). II. To test for moderators of short-term and longitudinal patient outcomes (secondary objectives). III. To identify facilitators and barriers to implementation of the enhanced eHealth and chatbot enabled delivery model and standard remote services. OUTLINE: Patients are randomized to 1 of 2 arms. Non-patient participants are assigned to arm 3. ARM I: 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. ARM II: 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. ARM III: Non-patient participants complete an interview on study. After completion of study intervention, patients are followed up at 6 and 12 months.

Conditions

• Miscellaneous Neoplasm, Nos
• Non-Neoplastic Condition, Nos

Interventions

Type	Name	Description
OTHER	Telemedicine	Undergo telehealth visit with genetic counselor for pretest genetic education
OTHER	Genetic Testing	Complete standard of care genetic testing
OTHER	Telemedicine	Undergo telehealth visit with genetic counselor for disclosure of results
OTHER	Internet-Based Intervention	Receive access to Genetic Journey Chatbot
OTHER	Educational Intervention	Complete digital pre-test genetic education
BEHAVIORAL	Patient Navigation	Utilize chatbot to answer questions, assess barriers, and provide reminders for next steps during the testing period
OTHER	Interview	Complete interview
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2025-12-10
• Primary completion: 2028-04-28
• Completion: 2029-04-30
• First posted: 2025-07-29
• Last updated: 2026-04-07

Locations

230 sites across 1 country: United States