BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers - a Multi-Site Randomized Controlled Trial

项目总结 这项建议的目标是确定博莱斯特的疗效，这是一种多组分的初级姑息性药物 旨在提高生活质量、缓解症状和减轻医院负担的护理干预- 为所有人群中最脆弱的人群之一提供基础护理：晚期患者具有复杂的护理需求 胃肠道和妇科(GI/GYN)癌症。GI/GYN癌症占美国癌症的30%以上 死亡，并造成巨大的痛苦。这些癌症通常通过腹膜和腹膜侵袭性扩散 通过盆腔器官侵犯，引起肠梗阻、顽固性腹水、输尿管和胆道梗阻， 盆腔瘘和无法愈合的伤口。缓解这些毁灭性的并发症需要采取如下干预措施 就像排气胃管、造口术和腹膜导尿管--让病人和家庭照顾者去应对 具有极其复杂的护理需求、严重的症状、频繁的并发症和再次住院。 为了满足这种巨大的需求，我们开发了一种由多种成分组成的初级姑息治疗 将1)护士、病人和家庭照顾者之间的纵向关系与 结构化远程医疗联系；2)具有电子患者报告结果以评估结果的移动医疗平台 症状并在就诊之间触发临床行动；以及3)量身定制的患者和照顾者症状 管理和技能培训。在试点随机试验中，Bolster已被证明是可行和可接受的， 大多数患者报告说它改善了症状(70%)，帮助应对(80%)，并高度推荐(95%)。 在这里，我们提出了一项多中心随机对照试验，研究对象包括 400名有复杂护理需求的晚期胃肠道/妇科癌症患者及其家庭照顾者。在入门指南中 阶段我们将把所有学习材料改编成西班牙语，因为拉丁裔是#年最大的少数民族人口。 美国。与现实世界的护理环境类似，这项试验将招募接受初级护理服务的患者-护理者双方 两个主要癌症中心的癌症护理，八个附属社区肿瘤学诊所，以及一个大型安全网 医院为多样化的人群和高比例的拉丁裔患者提供服务。我们的具体目标是1) 以症状、管理自我效能感为中介，确定支撑对患者生活质量的影响 2)确定支持物对照顾者负担、痛苦和自我的影响。 功效；3)使用 了解 RE-AIM模式、实施障碍和促进者 实现最佳可伸缩性和可持续性的必要组件 确定特定站点的特征 。我们的项目在以下方面具有创新性 使用双语护士提供远程保健干预，提供关键技能培训、自我管理 支持，以及一个主动管理症状的mHealth平台。如果有效，支撑将是一种非常有效的 可扩展模型，为大型多站点实施试验做好准备。

PROJECT SUMMARY The goal of this proposal is to determine the efficacy of BOLSTER, a multi-component primary palliative care intervention designed to improve quality of life, mitigate symptoms, and reduce burdensome hospital- based care for one of the most vulnerable of all populations: patients with complex care needs from advanced gastrointestinal and gynecologic (GI/GYN) cancers. GI/GYN cancers account for over 30% of US cancer deaths and cause tremendous suffering. These cancers often spread aggressively through the peritoneum and invade through pelvic organs, causing bowel obstructions, refractory ascites, ureteral and biliary obstructions, pelvic fistulas and non-healing wounds. Palliating these devastating complications requires interventions such as venting gastric tubes, ostomies, and peritoneal catheters—leaving patients and family caregivers to cope with extremely complex care needs, severe symptoms, frequent complications and rehospitalizations. In response to this great need, we developed BOLSTER, a multi-component primary palliative care intervention that combines 1) a longitudinal relationship among a nurse, patient, and family caregiver with structured telehealth contacts; 2) a mobile health platform with electronic patient-reported outcomes to assess symptoms and trigger clinical action between office visits; and 3) tailored patient and caregiver symptom management and skills training. BOLSTER has proven feasible and acceptable in pilot randomized trial, with most patients reporting it improved symptoms (70%), helped coping (80%), and recommending it highly (95%). Here we propose a multi-center randomized controlled trial of BOLSTER versus usual care (UC) among 400 patients with complex care needs from advanced GI/GYN cancer and their family caregivers. In a lead-in phase we will adapt all study materials into Spanish, given that Latinos are the largest minority population in the US. Mirroring real-world care settings, the trial will enroll patient-caregiver dyads who receive their primary cancer care at two major cancer centers, eight affiliated community oncology practices, and a large safety-net hospital serving richly diverse populations and a high proportion of Latino patients. Our Specific Aims are to 1) determine the effects of BOLSTER on patient QOL, as mediated by symptoms, self-efficacy for managing them, and health care utilization; 2) determine the effects of BOLSTER on caregiver burden, distress, and self- efficacy; and 3) using understand the RE-AIM model, c barriers and facilitators to implementation to the necessary components for optimal scalability and sustainability haracterize site-specific . Our project is innovative in using bilingual nurses to deliver a telehealth intervention that provides critical skills training, self-management support, and an mHealth platform to proactively manage symptoms. If efficacious, BOLSTER will be a highly scalable model, primed for a large, multisite implementation trial.