Testing an Enhanced Digital Delivery Model for Inherited Cancer Genetic Testing in Young Adults With Cancer
Purpose
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.
Conditions
- Miscellaneous Neoplasm, Nos
- Non-Neoplastic Condition, Nos
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator 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. |
|
|
Experimental 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. |
|
Recruiting Locations
San Antonio 4726206, Texas 4736286 78229
More Details
- Status
- Recruiting
- Sponsor
- Alliance for Clinical Trials in Oncology
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.