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
基本信息
- 批准号:10583119
- 负责人:
- 金额:$ 74.14万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:Advanced Malignant NeoplasmAffectAscitesBiliaryBladderCancer CenterCancer EtiologyCancer PatientCaregiver BurdenCaregiver supportCaregiversCaringCathetersCementationCervicalCessation of lifeClinicalCommunity Clinical Oncology ProgramComplexDevicesDiscipline of NursingDistressEducationEnsureFamilyFamily CaregiverFistulaGoalsHealthcareHomeHospitalizationHospitalsImmigrantInterventionIntestinal ObstructionIntestinesInvadedLatinoLatino PopulationLeadLearningMalignant - descriptorMalignant Female Reproductive System NeoplasmMalignant NeoplasmsMalignant neoplasm of gastrointestinal tractManaged CareMediatingMedicalMinority GroupsModelingMonitorNeoplasm MetastasisNursesObstructionOffice VisitsOncologyOperative Surgical ProceduresOrganOstomyPainPalliative CarePatient CarePatientsPelvisPeritonealPeritoneumPhasePilot ProjectsPopulationPopulation HeterogeneityQuality of CareQuality of lifeRandomizedRandomized, Controlled TrialsReach, Effectiveness, Adoption, Implementation, and MaintenanceRecommendationRefractoryReportingResourcesSafetySelf EfficacySelf ManagementSiteStomachStructureSymptomsSystemTestingTissuesTouch sensationTrustTubeUrinary tractVentVisceralVisitacceptability and feasibilitybiliary tractbilingualismcancer carecare fragmentationcare systemschronic care modelcopingefficacy evaluationelectronic patient reported outcomesempowermentend of lifeethnic diversityethnic minority populationfeedinghealth care service utilizationhigh riskhospice environmenthospital patient carehospital readmissionimplementation facilitatorsimplementation trialimprovedinnovationmHealthnon-healing woundspalliateparticipant enrollmentprogramsracial diversityracial minority populationrandomized trialrecruitreduce symptomsresponsesafety netskills trainingsymptom managementsymptomatic improvementtelehealththerapy designtreatment as usualtumorwound care
项目摘要
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。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Alexi A Wright其他文献
Threats of Bots and Other Bad Actors to Data Quality Following Research Participant Recruitment Through Social Media: Cross-Sectional Questionnaire (Preprint)
通过社交媒体招募研究参与者后,机器人和其他不良行为者对数据质量的威胁:跨部门调查问卷(预印本)
- DOI:
10.2196/preprints.23021 - 发表时间:
2020 - 期刊:
- 影响因子:6
- 作者:
Rachel A. Pozzar;M. Hammer;Meghan Underhill;Alexi A Wright;J. Tulsky;Fangxin Hong;D. Gundersen;D. Berry - 通讯作者:
D. Berry
Identification of distinct symptom profiles in patients with gynecologic cancers using a pre-specified symptom cluster
使用预先指定的症状群识别妇科癌症患者的不同症状特征
- DOI:
- 发表时间:
2023 - 期刊:
- 影响因子:3.1
- 作者:
M. Hammer;B. Cooper;Lee;Alexi A Wright;Rachel A. Pozzar;S. Blank;Bevin Cohen;Laura Dunn;S. Paul;Y. Conley;J. Levine;C. Miaskowski - 通讯作者:
C. Miaskowski
Cancer Survivors' Perspectives of Virtual Yoga for Chronic Chemotherapy-Induced Peripheral Neuropathy Pain During the COVID-19 Pandemic
癌症幸存者对虚拟瑜伽治疗 COVID-19 大流行期间慢性化疗引起的周围神经病变疼痛的看法
- DOI:
- 发表时间:
2022 - 期刊:
- 影响因子:0
- 作者:
Robert Knoerl;Julianna Bockhoff;Erica Fox;A. Giobbie;D. Berry;Juliana Berfield;J. Meyerhardt;Alexi A Wright;J. Ligibel - 通讯作者:
J. Ligibel
“You Want to Shield Your Kids”: Patients’ and Their Adult-Children's Serious Illness Conversations
“你想保护你的孩子”:患者及其成年子女关于重病的谈话
- DOI:
10.1016/j.jpainsymman.2024.12.014 - 发表时间:
2025-05-01 - 期刊:
- 影响因子:3.500
- 作者:
Anny THR Fenton;Bernadette Blashill;Anna C Revette;Alexis Mann;Maija Reblin;Andrea C Enzinger;Katherine A Ornstein;Supriya Jain;Christopher R Manz;James A Tulsky;Alexi A Wright - 通讯作者:
Alexi A Wright
Alexi A Wright的其他文献
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{{ truncateString('Alexi A Wright', 18)}}的其他基金
Chemotherapy Near Death: Modifiable Factors and Outcomes in Ovarian Cancer
濒临死亡的化疗:卵巢癌的可改变因素和结果
- 批准号:
8508591 - 财政年份:2013
- 资助金额:
$ 74.14万 - 项目类别:
Chemotherapy Near Death: Modifiable Factors and Outcomes in Ovarian Cancer
濒临死亡的化疗:卵巢癌的可改变因素和结果
- 批准号:
8713962 - 财政年份:2013
- 资助金额:
$ 74.14万 - 项目类别:
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