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.

项目摘要 超过80％的儿童癌症存活（CC）会产生严重或威胁生命的晚期影响。 <20％ CCS获得了建议的生存护理，使命是终身共识指南 在治疗后2年开始对晚期效果的监视。 “金标准”癌症中心的生存 诊所为参加会议的CC提供了高质量的护理，但患者避免了过去的癌症和缺乏的癌症。 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， 以及自付费用 - 这些结构性问题有助于健康分布。与社区合作 在共享的护理模型中，初级保健提供者（PCP）诊所是克服这些障碍的承诺策略， 但是PCP缺乏知识，自我有效和与癌症中心的互动交流，并且很困惑 关于护理责任的划分。我们的干预是可扩展的，基于距离的，直接通知 由患者和PCP障碍和先前研究的偏好，并在全国范围内爆炸来提高 Covid-19危机珍贵的远程医疗服务。拟议的随机对照试验将招募240 化学疗法/放射后CCS 2.0 - 4.0年，以研究创新的多层次干预措施（即 人际关系和组织级别）由1）通过远程医疗的患者生存教育组成 癌症中心，2）EHR患者门户内部正在进行的患者监管教育计划，3）结构化 癌症中心和PCP诊所之间的交互式电话通信（带1年的随访），以及 4）与PCP诊所进行生存护理的面对面访问。比较组将随机分为 与他们的癌症中心生存诊所的亲自访问。这项研究包括4个比例高的中心 亚组容易受到生存护理分布的影响（即粗糙，黑色，拉丁裔，说西班牙语， 在社会经济上处于不利地位）。两组将被要求开始推荐监视以备后效应 在随机后的1年内，与原发肿瘤学家的肿瘤复发监测分开。我们的 具体目的是针对1-证明患者完成指南示威的监视测试 干预参与者在比较组中不较低，即10％以内；目标2-实现更大 1）患者知识，自我效能和激活以及2）PCP知识和自我效能感与生存护理 与比较组相比，干预参与者及其PCP；并瞄准3-确定 1）患者和2）PCP诊所的过程结果。还将在子组之间评估结果 生存护理分布。变革性影响：如果我们的干预证明了患者的完成 推荐的生存护理与癌症中心的生存诊所相当，我们的研究具有巨大 将推荐的终身护理提供给更大比例的CCS并减少生存护理的潜力 差异是在吸引患者和PCP以整合生存护理的同时，作为整体健康状况的一部分 维护。