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A Digital Health Tool for Improving Knowledge and Uptake of Genetic Testing among Black Cancer Survivors
Trial Status: active
This clinical trial evaluates a relational agent intervention (the Cancer Risk Evaluation [CARE] digital health tool), compared to enhanced usual care, for improving education about and uptake of genetic testing for hereditary cancer risk among Black cancer survivors. Black patients experience significant disparities in access to cancer genetic services and bear the largest cancer mortality burden of any racial/ethnic group. Despite the widespread availability and established usefulness of genetic testing, few Black cancer survivors meeting the testing criteria have been tested, leaving them and their families unaware of their potentially increased risk. The CARE digital health tool is a web-based tool that allows patients to engage with a digital assistant online to learn more about their personal and familial hereditary cancer risk, as well as genetic testing. The tool includes educational and patient testimonial videos, scripted and interactive education and decision support, the ability for patients to ask questions in real time, as well as the opportunity for patients to schedule a genetic counseling visit using the scheduling tool. The CARE digital health tool may be more effective at improving knowledge about and uptake of genetic testing among Black cancer survivors and their families, compared to usual care.
Inclusion Criteria
RANDOMIZED TRIAL INCLUSION:
18-80 years of age
Identify as Black or African American
At least 6-months post diagnosis with any of the following cancers: breast, ovarian, uterine, prostate, colorectal, melanoma, pancreatic
Have received treatment or follow-up oncology care at one of the participating sites in the prior two years
Meet National Comprehensive Cancer Network criteria for germline genetic testing (GT)
Able to read and speak in English
Exclusion Criteria
RANDOMIZED TRIAL EXCLUSION:
Do not speak English
Unable to access the Internet
Have previously undergone germline genetic testing for hereditary cancer risk
Are unable to provide informed consent
Additional locations may be listed on ClinicalTrials.gov for NCT06073626.
I. To compare the efficacy of the relational agent (RA) intervention versus (vs.) enhanced usual care (EUC) on engagement with genetic education and uptake of genetic testing for hereditary cancer risk among Black cancer survivors.
SECONDARY OBJECTIVES:
I. To test the impact of the RA on informed decision-making and psychosocial outcomes.
II. To explore potential mediators and moderators of the efficacy of the RA intervention.
OUTLINE:
USABILITY TESTING: Patients review a prototype of the CARE digital health tool and attend an interview in support of intervention refinement.
RANDOMIZED CONTROLLED TRIAL: Participants are randomized to 1 of 2 arms.
ARM I: Patients receive a clinical letter informing them of their own and their family's potential risk for carrying a genetic variant related to hereditary cancer, emphasizing their eligibility for genetic testing, and including a recommendation to consider scheduling a genetic counseling appointment.
ARM II: Patients receive access to the CARE digital health tool.
After completion of study intervention, patients are followed up at 1 and 6 months.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationRutgers Cancer Institute of New Jersey
