BRidging Information Divides and Gaps to Ensure Survivorship: the BRIDGES Randomized Controlled Trial of a Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship

项目摘要 超过80%的儿童癌症幸存者（CCS）会出现严重或危及生命的晚期效应。但<20% 的CCS接受推荐的生存护理，尽管有终身护理的共识指南， 从治疗后2年开始监测晚期效应。“黄金标准”癌症中心的生存率 诊所为参加的CCS提供高质量的护理，但患者避免提醒他们过去的癌症和缺乏 生存护理的知识和自我效能。其他障碍包括旅行距离、保险不足， 和自付费用-这些结构性问题造成了健康差距。与社区合作 初级保健提供者（PCP）诊所在一个共享的护理模式是一个有前途的战略，以克服这些障碍， 但PCP缺乏知识、自我效能和与癌症中心的互动交流， 关于护理责任的划分。我们的干预是可扩展的，基于距离的， 从以前的研究中，病人和PCP的障碍和偏好，并通过全国范围内的爆炸， 2019冠状病毒病危机引发的远程医疗服务。拟议的随机对照试验将招募240名 CCS化疗/放疗后2.0-4.0年，以研究创新的多水平干预（即， 人际和组织层面），包括：1）通过远程保健进行患者生存教育， 癌症中心，2）在EHR的患者门户网站内持续进行患者定制的教育计划，3）结构化的 癌症中心和PCP诊所之间的交互式电话通信（1年随访电话），以及 4)亲自到PCP诊所接受生存护理。对照组将随机分配至 亲自拜访他们的癌症中心生存诊所。本研究包括4个中心， 易受生存护理差异影响的亚组（即，农村，黑人，拉丁裔，西班牙语， 社会经济地位低下）。要求两组开始推荐的晚期效应监测 随机化后1年内，与主要肿瘤科医生的肿瘤复发监测分开。我们 具体目标是目标1-证明患者完成指南推荐的监测测试， 目标2-实现更大的目标， 1)患者知识、自我效能和激活; 2）PCP知识和生存护理自我效能 与对照组相比，干预参与者及其PCP之间的差异;以及目标3-确定 处理1）患者和2）PCP诊所的结果。还将在以下亚组中评估结局： 生存护理差异。变革性影响：如果我们的干预证明患者完成了 推荐的生存护理可与癌症中心生存诊所相媲美，我们的研究具有巨大的 向更大比例的CCS提供推荐的终身护理并减少生存护理的可能性 差异，同时让患者和PCP将生存护理整合为整体终身健康的一部分 上维护

PROJECT SUMMARY More than 80% of childhood cancer survivors (CCS) develop serious or life-threatening late effects. Yet <20% of CCS receive recommended survivorship care, despite the availability of consensus guidelines for lifelong surveillance for late effects starting 2 years post-therapy. The “gold standard” cancer center-based survivorship clinic provides high-quality care to CCS who attend, but patients avoid reminders of their past cancer and lack knowledge and self-efficacy for survivorship care. Other barriers include travel distance, inadequate insurance, and out-of-pocket costs—these structural issues contribute to health disparities. Partnering with community primary care provider (PCP) clinics in a shared model of care is a promising strategy to overcome these barriers, but PCPs lack knowledge, self-efficacy, and interactive communication with the cancer center and are confused about the division of care responsibilities. Our intervention is scalable and distance-based, is informed directly by patient and PCP barriers and preferences from previous studies, and is boosted by a nationwide explosion in telehealth services precipitated by the COVID-19 crisis. The proposed randomized controlled trial will enroll 240 CCS 2.0-4.0 years post-chemotherapy/radiation to investigate an innovative multi-level intervention (i.e., interpersonal and organizational levels) consisting of 1) patient survivorship education via telehealth with the cancer center, 2) ongoing patient-tailored education program within the EHR's patient portal, 3) a structured interactive phone communication between the cancer center and the PCP clinic (with 1-year follow-up call), and 4) an in-person visit with the PCP clinic for survivorship care. The comparison group will be randomized to an in-person visit with their cancer center survivorship clinic. This study includes 4 centers with high proportions of subgroups vulnerable to survivorship care disparities (i.e., rural, Black, Latinx, Spanish-speaking, socioeconomically disadvantaged). Both groups will be asked to begin recommended surveillance for late effects within 1-year post-randomization, separate from tumor recurrence monitoring by the primary oncologist. Our Specific Aims are to Aim 1- Demonstrate patient completion of guideline-recommended surveillance tests in intervention participants is not inferior, i.e. within 10%, to that in the comparison group; Aim 2- Achieve greater 1) patient knowledge, self-efficacy, and activation and 2) PCP knowledge and self-efficacy with survivorship care among intervention participants and their PCPs compared to the comparison group; and Aim 3- Ascertain process outcomes for the 1) patient and 2) PCP clinic. Outcomes will also be assessed among subgroups with survivorship care disparities. Transformative Impact: If our intervention demonstrates patient completion of recommended survivorship care comparable to cancer center survivorship clinic, our study has the enormous potential to deliver recommended lifelong care to a larger proportion of CCS and reduce survivorship care disparities, while engaging patients and PCPs to integrate survivorship care as part of overall, lifelong health maintenance.