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 该提案的目的是确定Bolster的效率，Bolster是一种多组分的主要姑息治疗 护理干预措施旨在改善生活质量，减轻症状并减少Burnishome医院 - 基于所有人群中最脆弱的人之一：高级护理需求的患者 胃肠道和妇科（GI/GYN）癌症。 GI/GYN CANCERS占美国癌症的30％以上 死亡并造成巨大的痛苦。这些癌症通常会通过腹膜积极扩散 通过骨盆器官入侵，导致肠道物体，难治性腹水，输尿管和胆道物体， 骨盆瘘和非治疗奖金。姑息这些毁灭性并发症需要干预措施 作为排气的胃管，骨质和腹膜导管 - 使患者和家庭护理人员应对 满足了极其复杂的护理需求，严重的症状，经常并发症和复苏。 为了应对这一巨大需求，我们开发了Bolster，这是一种多组分的主要姑息治疗 结合1）护士，患者和家庭护理人员之间的纵向关系 结构化远程医疗联系人； 2）一个具有电子患者报告结果的移动健康平台以评估 症状并触发办公室访问之间的临床动作； 3）量身定制的患者和护理人员症状 管理和技能培训。 Bolster在试验随机试验中已被证明可行和可接受，并且 大多数报告IT的患者改善了症状（70％），帮助应对（80％），并推荐高度（95％）。 在这里，我们提出了一项多中心的Bolster与常规护理（UC）的多中心随机对照试验（UC） 400名来自晚期GI/GYN癌症的复杂护理需求的患者及其家庭护理人员。在引导中 阶段我们将把所有研究材料都适应西班牙语，因为拉丁美洲人是最大的少数民族人口 美国。镜像现实世界的护理设置，试验将招募接受其主要的患者护理人员二元组 两个主要癌症中心的癌症护理，八个会员社区肿瘤学实践和一个大型安全网 医院为各种各样的人群提供服务，并在拉丁裔患者中为大部分。我们的具体目的是1） 确定Bolster对患者QOL的影响，由符号介导 他们和医疗保健利用； 2）确定辅助者对伯恩（Burnen），苦难和自我的影响 效率; 3）使用 理解 Re-Aim模型，C障碍和促进者实施 最佳可扩展性和可持续性的必要组件 特定于现场的恶劣 。我们的项目具有创新性 使用双语护士提供远程医疗干预措施，提供关键的技能培训，自我管理 支持和一个主动管理症状的MHealth平台。如果高效，辅助将是一个高度 可扩展模型，用于大型多站点实施试验。