一项混合 1 型有效性-实施试验的研究方案，旨在测试虚拟烟草治疗在肿瘤实践中的应用 [无烟支持研究 2.0]。

Study protocol for a hybrid type 1 effectiveness-implementation trial testing virtual tobacco treatment in oncology practices [Smokefree Support Study 2.0].

机构信息

Department of Psychiatry, Massachusetts General Hospital / Harvard Medical School, 100 Cambridge Street, Suite 1600, Boston, MA, 02114, USA.

Mongan Institute Health Policy Research Center, Massachusetts General Hospital, Boston, MA, USA.

出版信息

BMC Public Health. 2022 Jul 15;22(1):1359. doi: 10.1186/s12889-022-13631-w.

DOI:10.1186/s12889-022-13631-w

PMID:35841024

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9284951/

Abstract

BACKGROUND

Persistent smoking among patients diagnosed with cancer is associated with adverse clinical outcomes, yet an evidence-based tobacco use intervention has not been well-integrated into cancer care in community oncology settings. This paper describes the protocol of a nation-wide clinical trial conducted by the ECOG-ACRIN National Cancer Institute (NCI) Community Oncology Research Program (NCORP) Research Base to assess the effectiveness of a virtual tobacco treatment intervention and the process of implementing tobacco treatment in NCORP community oncology settings.

METHODS/DESIGN: This two-arm, multisite (n: 49 NCORP sites) hybrid type 1 effectiveness-implementation randomized controlled trial compares the effectiveness of a Virtual Intervention Treatment (VIT) versus an Enhanced Usual Control (EUC) among English and Spanish speaking patients recently diagnosed with cancer, reporting current smoking and receiving care at a participating NCORP Community or Minority/Underserved Site. The VIT includes up to 11 virtual counseling sessions with a tobacco treatment specialist and up to 12 weeks of nicotine replacement therapy (NRT). The EUC arm receives a referral to the NCI Quitline. The primary study outcome is biochemically confirmed 7-day point prevalence smoking abstinence. Moderators of treatment effect will be assessed. The study evaluates implementation processes from participating NCORP site staff via survey, administrative, and focus group data, including reach, acceptability, appropriateness, fidelity, feasibility, adoption, cost and sustainability outcomes.

DISCUSSION

This trial will generate findings about the effectiveness of an evidence-based virtual tobacco treatment intervention targeting patients diagnosed with cancer and illuminate barriers and facilitators that influence implementing tobacco treatment into community oncology settings nationally. In the era of COVID-19, virtual care solutions are vital for maximizing access and utilization of tobacco treatment delivery.

TRIAL REGISTRATION

ClinicalTrials.gov (NCT03808818) on January 18th, 2019; Last update posted: May 21st, 2020.

摘要

背景

在被诊断患有癌症的患者中，持续吸烟与不良临床结局相关，但基于证据的烟草使用干预措施并未很好地整合到社区肿瘤学环境中的癌症护理中。本文介绍了由 ECOG-ACRIN 国家癌症研究所（NCI）社区肿瘤学研究计划（NCORP）研究基地进行的一项全国性临床试验的方案，以评估虚拟烟草治疗干预的有效性以及在 NCORP 社区肿瘤学环境中实施烟草治疗的过程。

方法/设计：这是一项两臂、多地点（n=49 个 NCORP 地点）混合 1 型有效性-实施随机对照试验，比较虚拟干预治疗（VIT）与增强常规对照（EUC）在最近被诊断患有癌症、报告当前吸烟并在参与 NCORP 社区或少数民族/服务不足站点接受治疗的英语和西班牙语患者中的有效性。VIT 包括最多 11 次与烟草治疗专家的虚拟咨询会议和最多 12 周的尼古丁替代疗法（NRT）。EUC 臂将被转介到 NCI 戒烟热线。主要研究结果是通过生物化学确认的 7 天点流行率吸烟戒断。将评估治疗效果的调节剂。该研究通过调查、行政和焦点小组数据评估参与 NCORP 站点工作人员的实施过程，包括覆盖范围、可接受性、适当性、保真度、可行性、采用、成本和可持续性结果。