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Testing an Enhanced Digital D...

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

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

535 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2031-01-15

Brief Summary

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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.

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Detailed Description

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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

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Miscellaneous Neoplasm, Nos Non-Neoplastic Condition, Nos

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm I (standard remote genetic services)

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.

Group Type ACTIVE_COMPARATOR

Survey Administration

Intervention Type OTHER

Ancillary studies

Telemedicine

Intervention Type OTHER

Undergo telehealth visit with genetic counselor for pretest genetic education

Genetic Testing

Intervention Type OTHER

Complete standard of care genetic testing

Telemedicine

Intervention Type OTHER

Undergo telehealth visit with genetic counselor for disclosure of results

Arm II (Genetic Journey Chatbot)

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.

Group Type EXPERIMENTAL

Internet-Based Intervention

Intervention Type OTHER

Receive access to Genetic Journey Chatbot

Educational Intervention

Intervention Type OTHER

Complete digital pre-test genetic education

Patient Navigation

Intervention Type BEHAVIORAL

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

Interview

Intervention Type OTHER

Complete interview

Survey Administration

Intervention Type OTHER

Ancillary studies

Telemedicine

Intervention Type OTHER

Undergo telehealth visit with genetic counselor for pretest genetic education

Genetic Testing

Intervention Type OTHER

Complete standard of care genetic testing

Telemedicine

Intervention Type OTHER

Undergo telehealth visit with genetic counselor for disclosure of results

Interventions

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Internet-Based Intervention

Receive access to Genetic Journey Chatbot

Intervention Type OTHER

Educational Intervention

Complete digital pre-test genetic education

Intervention Type OTHER

Patient Navigation

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

Intervention Type BEHAVIORAL

Interview

Complete interview

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Telemedicine

Undergo telehealth visit with genetic counselor for pretest genetic education

Intervention Type OTHER

Genetic Testing

Complete standard of care genetic testing

Intervention Type OTHER

Telemedicine

Undergo telehealth visit with genetic counselor for disclosure of results

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela Bradbury, MD

Role: STUDY_CHAIR

Alliance for Clinical Trials in Oncology

Locations

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