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

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• Uptake of genetic counseling [Time frame: Within 6 months of baseline]
• Uptake of genetic testing [Time frame: Within 6 months of baseline]

Secondary outcome measures (12)

• Knowledge of genetic disease [Time frame: Up to 42 months post registration]
• Test result recall [Time frame: Up to 42 months post registration]
• Perceptions of genetic disease [Time frame: Up to 42 months post registration]
• Anxiety [Time frame: Up to 42 months post registration]
• Depression [Time frame: Up to 42 months post registration]
• Disease-specific distress [Time frame: Up to 42 months post registration]
• Impact of cancer risk [Time frame: Up to 42 months post registration]
• Satisfaction with genetic services [Time frame: Up to 30 months post registration]
• Attitude toward genetic testing [Time frame: Up to 24 months post registration]
• Lifestyle behaviors [Time frame: Up to 42 months post registration]
• Health behaviors [Time frame: Up to 42 months post registration]
• Communication to at-risk relatives [Time frame: Up to 42 months post registration]

Eligibility criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 280 centers

• Anchorage Associates in Radiation Medicine — Anchorage
• Alaska Breast Care and Surgery LLC — Anchorage
• Alaska Oncology and Hematology LLC — Anchorage
• Alaska Women's Cancer Care — Anchorage
• Katmai Oncology Group — Anchorage
• Providence Alaska Medical Center — Anchorage
• Fairbanks Memorial Hospital — Fairbanks
• Cancer Center at Saint Joseph's — Phoenix
• … and 272 more centers

Identifiers

NCT: NCT07091617 · A232301CD · NCI-2025-02152

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗