A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials
2019年4月22日 更新者：Case Comprehensive Cancer Center
The goal of this research study is to find out if providing patients who are enrolled in phase 1 clinical trials with structured supportive care will enable them to continue in the Phase 1 trial longer and improve their quality of life by reducing or treating side effects and by providing emotional and social support to the patient and family.
The structured supportive or palliative care intervention will be provided by a team of trained specialists which include doctors, nurses, social workers and spiritual care providers.
The supportive care team will provide treatment to address symptoms, such as pain or anxiety, caused by the cancer itself or from the treatment.
The team can make referrals to other specialists.
Such as psychologists or nutritionist, if needed, and can help arrange for services to address home care needs.
研究概览
详细说明
Primary Objective(s): To assess symptoms, adverse events, duration on study, reason for study discontinuation, and quality of life among patients participating in phase I clinical trials who receive structured palliative care, and those who receive standard supportive care. Duration on study will serve as the primary objective for sample size determination.
Secondary Objective(s):
1. To describe the quantity (e.g. hours), type, and cost of palliative care personnel services used by patients and caregivers receiving structured palliative care.
Exploratory:
- To compare adverse event profiles, duration on study, and quality of life between patients who receive structured palliative care and those receiving standard supportive care.
- To compare caregiver burden and quality of life between the study arms.
研究类型
介入性
注册 (实际的)
132
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
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Ohio
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Cleveland、Ohio、美国、44106
- Case Comprehensive Cancer Center
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-
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
是的
有资格学习的性别
全部
描述
Patient Inclusion Criteria:
- Patients must be enrolled in a Phase 1 clinical trial and be within 2 weeks of starting the experimental therapy or intervention.
- Patients are eligible to enroll on this study with or without the enrollment of their caregiver.
Patient Exclusion Criteria:
- Patients diagnosed with a hematologic malignancy.
Caregiver Inclusion Criteria:
- Any caregiver is considered eligible for this study; The caregiver is the person identified by the patient as the one who provides the most regular physical and/or emotional support.
- Caregivers must be willing to complete surveys at baseline and on monthly basis.
Caregiver Exclusion Criteria:
- Caregivers who are solely professional, paid caregivers
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：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Standard Supportive Care
|
Supportive care for the patient and caregiver will be provided by the treating oncologist.
|
|
实验性的：Structured Supportive Care
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Supportive care for the patient and caregiver will be provided by the outpatient palliative care team which includes clinicians with specialized palliative care training, social workers, spiritual care specialists and mental health clinical nurse specialist.
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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 |
|---|---|---|
|
Average total MSAS score
大体时间：Up to 6 months
|
Assessment of patient burden
|
Up to 6 months
|
|
Average total FACT-G score
大体时间：Up to 6 months
|
Measure patient quality of life
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Up to 6 months
|
|
Reason for study discontinuation (Patient reported outcome)
大体时间：Up to 6 months
|
Measure of central tendency for why patients discontinued the phase I study.
Patient reported outcomes for reason for study discontinuation will be qualitatively assessed
|
Up to 6 months
|
|
Duration on Study
大体时间：Up to 6 months
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Measure of central tendency of the duration patients were on the phase I study.
Duration on study will serve as the primary objective for sample size determination
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Up to 6 months
|
|
Adverse events
大体时间：Up to 6 months
|
Measure of central tendency of adverse events.
AE will be described and further categorized as modifiable (primary symptom experience) and non-modifiable (laboratory abnormalities).
The influence of adverse events on study outcomes particularly duration on study and reason for study discontinuation will be assessed.
An exploratory weighted adverse event score will be calculated using the equation: adverse event score = ∑ (NAE * GAE) where N denotes the adverse event number, G denotes grade, AE denotes adverse event.
These scores will be compared between study arms
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Up to 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean number of hours of palliative care services
大体时间：Up to 6 months
|
Mean number of hours utilized by patients and caregivers who received structured palliative care.
This analysis will be descriptive, reporting measures of central tendency
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Up to 6 months
|
|
Type of palliative care services
大体时间：Up to 6 months
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Measure of central tendency for the type of palliative care services utilized by patients and caregivers who received structured palliative care.
This analysis will be descriptive, reporting measures of central tendency
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Up to 6 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Frequency of adverse events of patients receiving structured and usual supportive care
大体时间：Up to 6 months
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Up to 6 months
|
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Average days on study
大体时间：Up to 6 months
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Up to 6 months
|
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Change in FACT-G score
大体时间：From baseline to last contact, up to 6 months
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Change in patient symptom burden when compared to baseline between patients who received structured palliative care and those who received standard supportive care
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From baseline to last contact, up to 6 months
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Change in MSAS score
大体时间：From baseline to last contact, up to 6 months
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Change in quality of life when compared to baseline between patients who received structured palliative care and those who received standard supportive care
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From baseline to last contact, up to 6 months
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Change in CRA score
大体时间：From baseline to last contact, up to 6 months
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Change in caregiver burden when compared to baseline between those who received structured palliative care and those who received standard supportive care
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From baseline to last contact, up to 6 months
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Change in QOLLTI-F score
大体时间：From baseline to last contact, up to 6 months
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Change in caregiver quality of life as assessed through change in QOLLTI-F score when compared to baseline between those who received structured palliative care and those who received standard supportive care
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From baseline to last contact, up to 6 months
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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。
调查人员
- 首席研究员：Michelle Treasure, MD、Metrohealth Medical Center and Case Comprehensive Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2015年10月25日
初级完成 (实际的)
2019年1月10日
研究完成 (实际的)
2019年1月10日
研究注册日期
首次提交
2015年9月4日
首先提交符合 QC 标准的
2015年9月4日
首次发布 (估计)
2015年9月7日
研究记录更新
最后更新发布 (实际的)
2019年4月23日
上次提交的符合 QC 标准的更新
2019年4月22日
最后验证
2019年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.