This clinical trial develops and tests a digital health tool to improve genetic testing (GT) learning and decision making in patients with hereditary cancer. GT for cancer risk tests deoxyribonucleic acid (DNA) to look for a genetic alteration that may indicate an increased risk for developing a cancer. Recent advances in DNA testing have made it more common to use genetic testing results in cancer treatment and prevention. Many patients with hereditary cancer risks are not referred for GT, this is related to many different factors. New and more efficient approaches for patient GT support are needed to help increase testing among patients with hereditary cancer risks. The digital health tool used in this study is called a relational assistant (RA). The RA provides patients an interactive educational environment with GT decisional support, as well as assistance in accessing GT. Using RA may improve GT learning and decision making in patients with hereditary cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06184867.
PRIMARY OBJECTIVES:
I. Finalize the development and optimize usability of the CATALYST digital intervention (i.e., also known as relational assistant [RA]).
II. Evaluate the feasibility and acceptability of a streamlined cancer genomic care delivery model in cancer survivors.
III. Assess genetic counseling (GC) and genetic testing (GT) uptake and conduct a process evaluation to measure barriers/facilitators to GC, GT and use of the CATALYST intervention and engagement with the RA.
OUTLINE: Patients are randomized to 1 of 2 arms during phase 3.
PHASE 1 (USER TESTING): Patients use the smart device RA which includes educational videos, frequently asked question resources, questionnaires, and access to genetic testing kits and/or counseling. Patients then participate in a guided virtual interview over 45-60 minutes and complete usability questionnaires on study.
PHASE 2 (USABILITY TESTING): Patients use the smart device RA which includes educational videos, frequently asked question resources, questionnaires, and access to genetic testing kits and/or counseling. Patients then participate in a virtual think aloud interview over 30-45 minutes while logged in to smart device RA platform. Patients also complete usability questionnaires on study.
PHASE 3 (PILOT TESTING):
ENHANCED USUAL CARE (EUC) ARM: Patients receive a clinical letter informing them of their potential risk for carrying a harmful hereditary cancer risk, their eligibility for GT, a recommendation to consider a GC appointment, and a link to the Cancer Institute of New Jersey (CINJ) high-risk clinic website on study. Patients may also optionally undergo GT and/or GC on study.
RA ARM: Patients receive a clinical letter via mail, email, or electronic medical record with a link to use the final phase 3 interactive smart device RA. Patients use the final phase 3 interactive smart device RA which includes educational video with decision support for GT and real-time questions and answers. Patients may receive reminders to undergo GT and may optionally undergo GT and/or GC on study.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationRutgers Cancer Institute of New Jersey
Principal InvestigatorAnita Y. Kinney
