Home Hospital for Lymphoma
2022年10月26日 更新者：El-Jawahri, Areej,M.D.、Massachusetts General Hospital
Supportive Oncology Care at Home Intervention for Patients With Lymphoma
The goal of this research is to evaluate an intervention, which the investigators call "Home Hospital for Lymphoma," that involves remote patient monitoring and home-based supportive care for patients hospitalized with lymphoma at Massachusetts General Hospital.
研究概览
详细说明
This research study is a single arm pilot Feasibility Study, which is the first-time investigators are examining this hospital at home intervention for patients with lymphoma.
The research study procedures include screening for eligibility, questionnaires, remote patient monitoring (e.g. patient-reported symptoms and home monitored vital signs) and home-based supportive care (e.g. visits to patients' homes to address and manage any concerning issues identified), and interviews of participants, caregivers, and clinicians asking their perceptions of the Home Hospital for Lymphoma program.
Participants will include 3 groups:
Enrolled participants receiving the hospital at home intervention, caregivers of participants, and clinicians.
Participants will be in the research study for about six months after consent. It is expected that up to 38 participants will take part in this research study.
研究类型
介入性
注册 (实际的)
3
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Massachusetts
-
Boston、Massachusetts、美国、02114
- Massachusetts General Hospital Cancer Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 18 or older
- Receiving their lymphoma care with curative intent at MGH (treatment intent based upon chemotherapy order in the electronic medical record)
- Hemodynamically stable during the first 24 hours of hospital admission at MGH
- Residing within the designated geographic area for MGH Home Hospital Service (an approximately 10-mile radius from MGH)
- Able to communicate and respond to questionnaires in English
- Lives with a family member or a friend who supports the patient at home
- Deemed eligible for supportive oncology care at home based on the MGH Home Hospital clinician evaluation
Exclusion Criteria:
- Those admitted to the intensive care unit
- Have high oxygen requirement (FIO2 > 0.4)
- Experience active angina or cardiac arrythmias
- Have a planned inpatient surgical or interventional procedure
- Have uncontrolled psychiatric illness or impaired cognition that prohibits complying with the study procedures
- Have uncontrolled pain requiring intravenous pain medications
- Those deemed ineligible based on the Home Hospital Service clinician evaluation
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Home Hospital for Lymphoma
The Home Hospital for Lymphoma intervention entails the following: patient-reported symptoms and vital signs with appropriate triggers for phone calls and home visits, and regular communication with oncology clinicians regarding care delivered at home to ensure continuity of care.
|
Remote monitoring and home-based care designed for hospitalized patients with lymphoma
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
enrollment rate
大体时间：1 year
|
The primary endpoint is feasibility.
The proposed intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study
|
1 year
|
|
retention rate
大体时间：1 year
|
The primary endpoint is feasibility.
The proposed intervention will be deemed feasible if those enrolled patients complete at least 60% of daily patient-reported symptom assessment.
|
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
干预的可接受性
大体时间：1年
|
通过退出个人访谈获得的患者、护理人员和临床医生关于可接受性的定性可接受性评级（即
干预的有用性、有效性和相关性）来自患者、家庭护理人员和临床医生。
如果 ≥ 60% 的患者、家庭护理人员和临床医生报告干预有帮助，则认为干预是可以接受的。
|
1年
|
|
Rates of completion of daily vital signs
大体时间：1 year
|
Proportion of participants that complete daily reporting of vital signs during their home hospital admission.
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1 year
|
|
Rates of Adverse Events
大体时间：1 year
|
The rates of Adverse Events and Serious Adverse Events that are judged by the treating lymphoma clinician to be at least possibly related to the study intervention.
|
1 year
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Symptom burden (Edmonton Symptom Assessment System-revised - ESAS-r)
大体时间：1 year
|
Change in participants' symptom burden as measured by the ESAS-r throughout the study.
The ESAS-r ranges 0-10 for each symptom with higher scores indicating worse symptom burden.
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1 year
|
|
Psychological distress (Hospital Anxiety and Depression Scale - HADS)
大体时间：1 year
|
Change in psychological distress as measured by the HADS, with subscale ranges from 0-21 with higher scores indicating worse psychological distress.
|
1 year
|
|
Quality of life (Functional Assessment of Cancer Therapy-General - FACT-G)
大体时间：1 year
|
Change in quality of life as measured by the FACT-G throughout the study, with range of 0-108 and higher scores indicating better quality of life.
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1 year
|
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Length of home hospital admission
大体时间：1 year
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Number of days the participant receives home hospital care through the home hospital program.
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1 year
|
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Number of home visits
大体时间：1 year
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Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to participants at their home.
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1 year
|
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Number of phone calls
大体时间：1 year
|
Number of phone calls required per participants as well as the average duration of these calls.
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1 year
|
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Number of urgent visits
大体时间：1 year
|
The number of urgent visits to clinic per participant and the proportion of participants who have an urgent visit to clinic.
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1 year
|
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Number of emergency department (ED) visits The number of imaging tests ordered during home hospital admission
大体时间：1 year
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The number of emergency department (ED) visits per participant and the proportion of participants who have an ED visit.
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1 year
|
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Number of hospital readmissions
大体时间：1 year
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The number of hospital readmissions in 30 days per participant and the proportion of participants who have a hospital readmission within 30 days.
|
1 year
|
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Number of imaging studies
大体时间：1 year
|
The number of imaging studies obtained per participant during the Home Hospital admission.
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1 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年6月1日
初级完成 (实际的)
2021年1月1日
研究完成 (实际的)
2021年1月30日
研究注册日期
首次提交
2020年6月6日
首先提交符合 QC 标准的
2020年6月8日
首次发布 (实际的)
2020年6月9日
研究记录更新
最后更新发布 (实际的)
2022年10月28日
上次提交的符合 QC 标准的更新
2022年10月26日
最后验证
2022年10月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 19-613
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials.
De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement.
Requests may be directed to: [contact information for Sponsor Investigator or designee].
The protocol and statistical analysis plan will be made available on Clinicaltrials.gov
only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD 共享时间框架
Data can be shared no earlier than 1 year following the date of publication
IPD 共享访问标准
Contact the Partners Innovations team at http://www.partners.org/innovation
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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