Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients (A&SC)
2015年4月6日 更新者:US Department of Veterans Affairs
The diagnosis of advanced, incurable cancer at different stages of the adult life span holds a variety of meanings for family members who often must play critical roles in patient care and decision-making.
Family caregivers are greatly affected by the diagnosis and treatment of late-stage cancer in a loved one and may find it difficult to meet the demands of taking care of their loved one through end-of-life care and taking care of their own well-being.
This grant provides funding to examine processes and outcomes of the intervention for family caregivers of advanced cancer patients.
研究概览
详细说明
We are testing a coping and communication support (CCS) intervention for advanced stage cancer patients and their family caregivers over the period when goals of care may shift, i.e. beginning shortly after diagnosis.
This randomized clinical trial is being conducted in two urban tertiary cancer clinics that reach patients and families in low income and diverse underserved populations: the Louis Stokes Cleveland VAMC and MetroHealth Medical Center.
Recruitment and randomization are based on patient's diagnosis and age.
The patient had to have been diagnosed with a stage IV cancer within a year of enrollment and they must fall into one of two age groups: middle-aged (ages 40-60); or older (61 and older).
Patients are stratified by age group and then randomized to usual care or CCS intervention.
Family care-givers are randomized along with the patient.
Trained clinical nurse specialists with advanced training in mental health serve as CCS practitioners.
They are available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise.
The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.
研究类型
介入性
注册 (实际的)
559
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
- Louis Stokes VA Medical Center, Cleveland, OH
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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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients diagnosed within 1 year with advanced cancer (stage IV), aged 40 years or older.
- Patients must be cognitively intact at time of enrollment.
- Patient need not have family care-giver to be enrolled, but if there is one, FCG is enrolled with the patient. FCG need not be 40 years of age.
Exclusion Criteria:
- Less than stage IV cancer, stage IV cancer diagnosed over 1 year previously or younger than 40 years of age.
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: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 |
|---|---|
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实验性的:Arm 1
In the intervention arm, Patients and their family caregivers have access to a coping and communication support practitioner (CCSP) (see intervention description) in addition to receiving the usual care in the site.
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Trained clinical nurse specialists with masters� degrees in mental health will serve as CCS practitioners and they will be available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise. The CCS intervention is tailored to individual preferences over time, and designed to accommodate different age groups, especially older adults and their families. |
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无干预:Arm 2
In the control arm, Patients are receiving the usual care in the site.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.
大体时间:one year
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one year
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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To assess the efficacy of the intervention among patients in coping and decisions around end of life.
大体时间:two years
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two years
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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:Julia Rose, PhD MA、Louis Stokes VA Medical Center, Cleveland, OH
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。
一般刊物
- Bowman KF, Rose JH, Radziewicz RM, O'Toole EE, Berila RA. Family caregiver engagement in a coping and communication support intervention tailored to advanced cancer patients and families. Cancer Nurs. 2009 Jan-Feb;32(1):73-81. doi: 10.1097/01.NCC.0000343367.98623.83.
- Rose JH, Radziewicz R, Bowmans KF, O'Toole EE. A coping and communication support intervention tailored to older patients diagnosed with late-stage cancer. Clin Interv Aging. 2008;3(1):77-95. doi: 10.2147/cia.s1262.
- Rose JH, O'Toole EE, Einstadter D, Love TE, Shenko CA, Dawson NV. Patient age, well-being, perspectives, and care practices in the early treatment phase for late-stage cancer. J Gerontol A Biol Sci Med Sci. 2008 Sep;63(9):960-8. doi: 10.1093/gerona/63.9.960.
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
2004年6月1日
初级完成 (实际的)
2008年11月1日
研究完成 (实际的)
2008年11月1日
研究注册日期
首次提交
2005年3月18日
首先提交符合 QC 标准的
2005年3月18日
首次发布 (估计)
2005年3月21日
研究记录更新
最后更新发布 (估计)
2015年4月7日
上次提交的符合 QC 标准的更新
2015年4月6日
最后验证
2009年4月1日
更多信息
与本研究相关的术语
其他研究编号
- IIR 03-255
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.