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
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Clinical Trial Information
Trial Contact: Frankos, Marie; Parker, Melanie; Armatti, Julie M; Singh, Sarah H; Jones, Jamie; Torrescano, Tanner
Trial Phone: 321-842-8738 ; 321-843-1036 ; 321-843-5284 ; 321.841.7561 ; 3218412008 ; 321-841-8271
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IRB No: xxxxx
Protocol Abbrev: A232301CD
Principal Investigator: Michelle Amit, DO
Age Group: Adult
ClinicalTrials.gov ID: NCT07091617
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Objective
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. -
Key Eligibility
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
