Contemporary clinical trials · 2026
Expanding access to cancer genetic care for cancer survivors: Rationale and design for a randomized controlled trial of a chatbot-based genetic education and testing.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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An Jinghua, Huq Maisha, Speiser Erin, Grumet Sherry, Peshkin Beth N, Heidt Emily, Adams-Campbell Lucile, Grisham Christopher, Tundealao Samuel, Yesha Rose, Toppmeyer Deborah, Isaacs Claudine, Sorgen Lia, Tan Naomi, Hooda-Nehra Anupama, Nix Melanie A, Reed Dorothy J, Staton Jimmie, Schwartz Marc D, Kinney Anita Y
Аннотация
BACKGROUND: Despite national guidelines recommending germline genetic testing (GT) for cancer survivors at high risk for hereditary cancers, GT remains underutilized, particularly among underserved populations who experience significant population health differences and higher cancer mortality. Barriers at the individual, interpersonal, and system levels contribute to this underutilization. Proactive clinical outreach and technology-based tools such as chatbots may help address these barriers and streamline cancer genetic service delivery, but culturally tailored chatbot interventions have rarely been tested for efficacy in Black cancer survivors. This paper describes the formative research and protocol for a multisite, randomized controlled trial testing a streamlined care delivery model addressing multilevel barriers to GT uptake.
METHODS: Using electronic health records from two health systems, we will proactively identify and enroll 428 Black patients who have a prior diagnosis of breast, ovarian, uterine, colorectal, prostate, or pancreatic cancer and meet national guideline criteria for genetic testing. Participants are randomized to either the Genetic Education Decision Assistant (GEDA), a chatbot-based intervention, or Enhanced Usual Care (EUC, a clinical letter recommending genetic counseling and testing). The primary outcome is genetic testing completion. Secondary outcomes include genetic counseling uptake, knowledge, psychological distress, and decision regret, satisfaction, and conflict.
DISCUSSION: This ongoing trial addresses an important translational gap by developing and implementing an alternative care delivery model that includes a chatbot to provide streamlined cancer genetic services. If effective, this intervention has the potential to reduce population differences in cancer genetics care and guide cancer risk reduction, surveillance, and cascade testing.
TRIAL REGISTRATION NUMBER: The trial is registered on clinicaltrials.gov (NCT06073626).
METHODS: Using electronic health records from two health systems, we will proactively identify and enroll 428 Black patients who have a prior diagnosis of breast, ovarian, uterine, colorectal, prostate, or pancreatic cancer and meet national guideline criteria for genetic testing. Participants are randomized to either the Genetic Education Decision Assistant (GEDA), a chatbot-based intervention, or Enhanced Usual Care (EUC, a clinical letter recommending genetic counseling and testing). The primary outcome is genetic testing completion. Secondary outcomes include genetic counseling uptake, knowledge, psychological distress, and decision regret, satisfaction, and conflict.
DISCUSSION: This ongoing trial addresses an important translational gap by developing and implementing an alternative care delivery model that includes a chatbot to provide streamlined cancer genetic services. If effective, this intervention has the potential to reduce population differences in cancer genetics care and guide cancer risk reduction, surveillance, and cascade testing.
TRIAL REGISTRATION NUMBER: The trial is registered on clinicaltrials.gov (NCT06073626).