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

弥合信息鸿沟和差距，确保生存：旨在提高儿童癌症生存依从性的多层次干预的 BRIDGES 随机对照试验

• 批准号: 10491902
• 负责人: NINA S KADAN-LOTTICK
• 金额: $ 57.72万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-21 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10491902
• 关键词: Adherence; Age; Black race; COVID-19 pandemic; Cancer Center; Cancer Survivorship; Caring; Chemotherapy and/or radiation; Clinic; Collaborations; Common Terminology Criteria for Adverse Events; Communication; Communities; Consensus; Diagnosis; Dissemination and Implementation; Education; Electronic Health Record; Eligibility Determination; Enrollment; Ensure; Explosion; Goals; Gold; Guidelines; Health; Institution; Insurance; Interactive Communication; Intervention; Interview; Knowledge; Late Effects; Latinx; Life; Maintenance; Malignant Childhood Neoplasm; Malignant Neoplasms; Medical Records; Methods; Modeling; Monitoring for Recurrence; Oncologist; Outcome; Patient Care; Patient Education; Patient-Focused Outcomes; Patients; Persons; Physicians; Primary Health Care; Process; Quality of Care; Randomized; Randomized Controlled Trials; Recommendation; Resources; Rural; Sampling; Self Efficacy; Services; Site; Structure; Subgroup; Surveys; Technology; Telephone; Testing; Text Messaging; Travel; Visit; Work; acceptability and feasibility; adherence rate; arm; base; cancer therapy; care providers; childhood cancer survivor; community center; comparison group; cost; follow-up; future implementation; health disparity; improved; individual patient; innovation; instrument; intervention participants; medical specialties; patient health information; patient portal; preference; primary endpoint; primary outcome; programs; provider-level barriers; socioeconomic disadvantage; survivorship; telehealth; tumor

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.

项目总结 超过80%的儿童癌症幸存者(CCS)会出现严重或危及生命的后遗症。但仍有20% 的CCS接受建议的生存护理，尽管有一致的终身指导方针 从治疗后2年开始监测远期效应。以癌症中心为基础的“黄金标准”生存 诊所为参加CCS的人提供高质量的护理，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--这些结构性问题导致了健康差距。与社区合作 共享护理模式中的初级保健提供者(PCP)诊所是克服这些障碍的一种有前途的战略， 但PCP缺乏知识，缺乏自我效能，缺乏与癌症中心的互动交流，感到困惑 关于护理责任的分工。我们的干预是可扩展的、基于远程的、直接通知的 由患者和PCP障碍和之前研究的偏好决定，并受到全国范围内的爆炸性增长的推动 新冠肺炎危机催生的远程医疗服务。拟议的随机对照试验将有240人参加 CCS在化疗/放疗后2.0-4.0年研究创新的多水平干预(即， 人际和组织层面)包括：1)通过远程健康教育患者的生存 癌症中心，2)在EHR的患者门户内持续的患者定制教育计划，3)结构化的 癌症中心和初级保健诊所之间的互动电话交流(包括为期一年的跟踪电话)，以及 4)亲临PCP诊所接受生存护理。对照组将被随机分成一组 亲临他们的癌症中心生存诊所。这项研究包括4个比例较高的中心 易受生存护理差异影响的亚群(即农村人、黑人、拉丁裔、西班牙语、 在社会经济上处于不利地位)。两组都将被要求开始推荐的晚期效应监测 在随机化后的1年内，与初级肿瘤学家监测的肿瘤复发分开。我们的 具体目标是目标1-证明患者完成了指南建议的监测测试 干预参与者并不比对照组差，即在10%以内；目标2-达到更大 1)患者知识、自我效能和激活度；2)PCP知识和生存护理自我效能 与对照组比较的干预参与者及其初级合作伙伴；以及目标3--确定 为1)患者和2)PCP诊所处理结果。还将在分组中评估结果，包括 生存护理方面的差距。变革性影响：如果我们的干预证明患者完成了 推荐的生存护理堪比癌症中心的生存诊所，我们的研究具有巨大的 向更大比例的CCS提供建议的终身护理并减少生存护理的可能性 差异，同时让患者和初级保健医生将生存护理整合为整体终身健康的一部分 维修。