Huntsman Cancer Institute, Salt Lake City, Utah.
Department of Communication, University of Utah, Salt Lake City.
JAMA Netw Open. 2024 Sep 3;7(9):e2432143. doi: 10.1001/jamanetworkopen.2024.32143.
Increasing numbers of unaffected individuals could benefit from genetic evaluation for inherited cancer susceptibility. Automated conversational agents (ie, chatbots) are being developed for cancer genetics contexts; however, randomized comparisons with standard of care (SOC) are needed.
To examine whether chatbot and SOC approaches are equivalent in completion of pretest cancer genetic services and genetic testing.
DESIGN, SETTING, AND PARTICIPANTS: This equivalence trial (Broadening the Reach, Impact, and Delivery of Genetic Services [BRIDGE] randomized clinical trial) was conducted between August 15, 2020, and August 31, 2023, at 2 US health care systems (University of Utah Health and NYU Langone Health). Participants were aged 25 to 60 years, had had a primary care visit in the previous 3 years, were eligible for cancer genetic evaluation, were English or Spanish speaking, had no prior cancer diagnosis other than nonmelanoma skin cancer, had no prior cancer genetic counseling or testing, and had an electronic patient portal account.
Participants were randomized 1:1 at the patient level to the study groups at each site. In the chatbot intervention group, patients were invited in a patient portal outreach message to complete a pretest genetics education chat. In the enhanced SOC control group, patients were invited to complete an SOC pretest appointment with a certified genetic counselor.
Primary outcomes were completion of pretest cancer genetic services (ie, pretest genetics education chat or pretest genetic counseling appointment) and completion of genetic testing. Equivalence hypothesis testing was used to compare the study groups.
This study included 3073 patients (1554 in the chatbot group and 1519 in the enhanced SOC control group). Their mean (SD) age at outreach was 43.8 (9.9) years, and most (2233 of 3063 [72.9%]) were women. A total of 204 patients (7.3%) were Black, 317 (11.4%) were Latinx, and 2094 (75.0%) were White. The estimated percentage point difference for completion of pretest cancer genetic services between groups was 2.0 (95% CI, -1.1 to 5.0). The estimated percentage point difference for completion of genetic testing was -1.3 (95% CI, -3.7 to 1.1). Analyses suggested equivalence in the primary outcomes.
The findings of the BRIDGE equivalence trial support the use of chatbot approaches to offer cancer genetic services. Chatbot tools can be a key component of sustainable and scalable population health management strategies to enhance access to cancer genetic services.
ClinicalTrials.gov Identifier: NCT03985852.
越来越多的未受影响的个体可能受益于遗传性癌症易感性的基因评估。自动化对话代理（即聊天机器人）正在为癌症遗传学领域开发；然而，需要与标准护理（SOC）进行随机比较。
研究聊天机器人和 SOC 方法在完成预测试遗传性癌症服务和基因检测方面是否等效。
设计、地点和参与者：这项等效性试验（扩大遗传性服务的范围、影响和提供[BRIDGE]随机临床试验）于 2020 年 8 月 15 日至 2023 年 8 月 31 日在美国 2 个医疗保健系统（犹他大学健康和 NYU 朗格健康）进行。参与者年龄在 25 至 60 岁之间，在过去 3 年内有过一次初级保健就诊，有资格接受癌症基因评估，会说英语或西班牙语，除非黑色素瘤皮肤癌外没有其他癌症诊断，没有接受过癌症基因咨询或检测，并且有电子患者门户账户。
在每个地点，患者按患者水平以 1:1 的比例随机分配到研究组。在聊天机器人干预组中，患者会收到患者门户外展信息中的邀请，以完成预测试遗传学教育聊天。在增强的 SOC 对照组中，患者被邀请与认证遗传咨询师预约进行预测试。
主要结果是完成预测试遗传性癌症服务（即预测试遗传学教育聊天或预测试遗传咨询预约）和完成基因检测。使用等效性假设检验比较研究组。
这项研究包括 3073 名患者（聊天机器人组 1554 名，增强 SOC 对照组 1519 名）。他们在推广时的平均（SD）年龄为 43.8（9.9）岁，大多数（3063 名中的 2233 名[72.9%]）为女性。共有 204 名患者（7.3%）为黑人，317 名（11.4%）为拉丁裔，2094 名（75.0%）为白人。两组之间完成预测试遗传性癌症服务的估计百分点差异为 2.0（95%CI，-1.1 至 5.0）。完成基因检测的估计百分点差异为-1.3（95%CI，-3.7 至 1.1）。分析表明主要结果具有等效性。
BRIDGE 等效性试验的结果支持使用聊天机器人方法提供癌症遗传服务。聊天机器人工具可以成为增强癌症遗传服务获取途径的可持续和可扩展的人口健康管理策略的关键组成部分。
ClinicalTrials.gov 标识符：NCT03985852。
