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

BOLSTER：加强晚期妇科和胃肠道癌症患者和护理人员的支持 - 一项多中心随机对照试验

• 批准号: 10583119
• 负责人: Alexi A Wright
• 金额: $ 74.14万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10583119
• 关键词: Advanced Malignant Neoplasm; Affect; Ascites; Biliary; Bladder; Cancer Center; Cancer Etiology; Cancer Patient; Caregiver Burden; Caregiver support; Caregivers; Caring; Catheters; Cementation; Cervical; Cessation of life; Clinical; Community Clinical Oncology Program; Complex; Devices; Discipline of Nursing; Distress; Education; Ensure; Family; Family Caregiver; Fistula; Goals; Healthcare; Home; Hospitalization; Hospitals; Immigrant; Intervention; Intestinal Obstruction; Intestines; Invaded; Latino; Latino Population; Lead; Learning; Malignant - descriptor; Malignant Female Reproductive System Neoplasm; Malignant Neoplasms; Malignant neoplasm of gastrointestinal tract; Managed Care; Mediating; Medical; Minority Groups; Modeling; Monitor; Neoplasm Metastasis; Nurses; Obstruction; Office Visits; Oncology; Operative Surgical Procedures; Organ; Ostomy; Pain; Palliative Care; Patient Care; Patients; Pelvis; Peritoneal; Peritoneum; Phase; Pilot Projects; Population; Population Heterogeneity; Quality of Care; Quality of life; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Refractory; Reporting; Resources; Safety; Self Efficacy; Self Management; Site; Stomach; Structure; Symptoms; System; Testing; Tissues; Touch sensation; Trust; Tube; Urinary tract; Vent; Visceral; Visit; acceptability and feasibility; biliary tract; bilingualism; cancer care; care fragmentation; care systems; chronic care model; coping; efficacy evaluation; electronic patient reported outcomes; empowerment; end of life; ethnic diversity; ethnic minority population; feeding; health care service utilization; high risk; hospice environment; hospital patient care; hospital readmission; implementation facilitators; implementation trial; improved; innovation; mHealth; non-healing wounds; palliate; participant enrollment; programs; racial diversity; racial minority population; randomized trial; recruit; reduce symptoms; response; safety net; skills training; symptom management; symptomatic improvement; telehealth; therapy design; treatment as usual; tumor; wound care

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.

项目摘要 该提案的目标是确定BOLSTER（一种多组分主要姑息治疗药物）的疗效 护理干预旨在改善生活质量，减轻症状，并减少医院负担， 为所有人群中最脆弱的人群之一提供基础护理：来自高级医疗机构的复杂护理需求患者 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，造成巨大的痛苦。这些癌症通常通过腹膜侵袭性扩散， 通过盆腔器官侵入，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减轻这些毁灭性的并发症需要干预， 作为排气胃管，造口术，腹膜导管，离开病人和家庭护理人员，以科普 他们需要极其复杂的护理，症状严重，并发症频繁，需要再次住院。 为了满足这一巨大需求，我们开发了BOLSTER，一种多组分初级姑息治疗 干预，结合1）护士，病人和家庭照顾者之间的纵向关系， 结构化的远程保健联系人; 2）一个移动的保健平台，具有电子患者报告的结果，以评估 症状和触发诊所访问之间的临床行动;和3）定制的患者和护理人员的症状 管理和技能培训。BOLSTER已在初步随机试验中证明是可行和可接受的， 大多数患者报告它改善了症状（70%），帮助应对（80%），并高度推荐（95%）。 在这里，我们提出了一个多中心的随机对照试验，BOLSTER与常规治疗（UC）， 400名需要复杂护理的晚期GI/GYN癌症患者及其家庭护理人员。在导入 在这一阶段，我们将把所有的学习材料改编成西班牙语，因为拉丁美洲人是西班牙最大的少数民族人口。 美方与现实世界的护理环境相似，该试验将招募患者-护理人员配对，他们接受他们的主要治疗， 两个主要癌症中心的癌症护理，八个附属社区肿瘤学实践和一个大型安全网 医院服务于丰富多样的人群和高比例的拉丁美洲患者。我们的具体目标是：（1） 确定BOLSTER对患者QOL的影响，通过症状、管理自我效能 他们，和医疗保健利用; 2）确定BOLSTER对照顾者负担，痛苦和自我的影响， 功效; 3）使用 理解 RE-AIM模型、实施障碍和促进因素， 实现最佳可扩展性和可持续性的必要组件 哈剌克斯特位的 .我们的项目是创新的， 使用双语护士提供远程医疗干预，提供关键技能培训，自我管理， 支持，以及一个移动健康平台，以主动管理症状。如果有效，BOLSTER将是一个高度 可扩展的模型，为大型多站点实施试验做好准备。