Foraker Randi E, Davidson Eleanor C, Dressler Emily V, Wells Brian J, Lee Simon Craddock, Klepin Heidi D, Winkfield Karen M, Hundley W Gregory, Payne Philip R O, Lai Albert M, Lesser Glenn J, Weaver Kathryn E
Washington University School of Medicine, Institute for Informatics, 600 S. Taylor Avenue, St. Louis, MO, 63110, USA.
Wake Forest School of Medicine, Department of Social Sciences and Health Policy, 1 Medical Center Boulevard, Winston-Salem, NC, 27157, USA.
Contemp Clin Trials Commun. 2021 Jun 16;22:100808. doi: 10.1016/j.conctc.2021.100808. eCollection 2021 Jun.
The purpose of this paper is to describe the Automated Heart-Health Assessment (AH-HA) study protocol, which demonstrates an agile approach to cancer care delivery research. This study aims to assess the effect of a clinical decision support tool for cancer survivors on cardiovascular health (CVH) discussions, referrals, completed visits with primary care providers and cardiologists, and control of modifiable CVH factors and behaviors. The COVID-19 pandemic has caused widespread disruption to clinical trial accrual and operations. Studies conducted with potentially vulnerable populations, including cancer survivors, must shift towards virtual consent, data collection, and study visits to reduce risk for participants and study staff. Studies examining cancer care delivery innovations may also need to accommodate the increased use of virtual visits.
METHODS/DESIGN: This group-randomized, mixed methods study will recruit 600 cancer survivors from 12 National Cancer Institute Community Oncology Research Program (NCORP) practices. Survivors at intervention sites will use the AH-HA tool with their oncology provider; survivors at usual care sites will complete routine survivorship visits. Outcomes will be measured immediately after the study visit, with follow-up at 6 and 12 months. The study was amended during the COVID-19 pandemic to allow for virtual consent, data collection, and intervention options, with the goal of minimizing participant-staff in-person contact and accommodating virtual survivorship visits.
Changes to the study protocol and procedures allow important cancer care delivery research to continue safely during the COVID-19 pandemic and give sites and survivors flexibility to conduct study activities in-person or remotely.
本文旨在描述自动心脏健康评估（AH-HA）研究方案，该方案展示了一种灵活的癌症护理研究方法。本研究旨在评估一种针对癌症幸存者的临床决策支持工具对心血管健康（CVH）讨论、转诊、与初级保健提供者和心脏病专家的就诊完成情况，以及可改变的CVH因素和行为控制的影响。2019冠状病毒病疫情已对临床试验的招募和运作造成广泛干扰。对包括癌症幸存者在内的潜在弱势群体进行的研究，必须转向虚拟同意、数据收集和研究访视，以降低参与者和研究人员的风险。研究癌症护理创新的研究可能还需要适应虚拟访视使用的增加。
方法/设计：这项群组随机混合方法研究将从12个国家癌症研究所社区肿瘤学研究项目（NCORP）机构招募600名癌症幸存者。干预地点的幸存者将与肿瘤学提供者一起使用AH-HA工具；常规护理地点的幸存者将完成常规的生存访视。在研究访视后立即测量结果，并在6个月和12个月时进行随访。在2019冠状病毒病疫情期间对研究进行了修订，以允许虚拟同意、数据收集和干预选项，目标是尽量减少参与者与工作人员的面对面接触，并适应虚拟生存访视。
研究方案和程序的改变使重要的癌症护理研究能够在2019冠状病毒病疫情期间安全继续进行，并使研究机构和幸存者能够灵活地亲自或远程开展研究活动。
