Evaluation of Cardiovascular Health Outcomes Among Survivors (ECHOS)
2013年11月25日 更新者：St. Jude Children's Research Hospital
This study will test a 2-tiered tailored intervention and evaluation of cardiovascular health outcomes among survivors designed to inform childhood cancer survivors about their individual cardiac risk and follow-up recommendations and to provide motivational support for cardiovascular (CV) screening.
This study will test if the addition of telephone motivational interviewing, tailored to behavioral constructs, is superior to the current standard of care in increasing survivors' CV screening.
研究概览
地位
完全的
详细说明
- This study will test the hypothesis that at 1 year post-intervention, a significantly greater proportion of the advanced-practice nurse (APN) phone counseling group will have undergone cardiovascular screening, as compared to the standard care group. Cardiovascular (CV) screening will be defined, based on established CV screening recommendations, as completion of an imaging evaluation of left ventricular systolic function (i.e., echocardiogram, multiple uptake gated acquisition scan, or cardiac magnetic resonance imaging).
This study will measure changes induced by the intervention in survivors' knowledge, motivation, fear, beliefs, affect, readiness for medical follow-up, and self-efficacy and these changes' potential mediating effects on CV screening.
- This study will provide a cost analysis of the ECHOS intervention in terms of the cost of left ventricular systolic function imaging per additional survivor screened, an estimate of the cost of standard care per survivor screened, and the cost of screening and follow-up per survivor screened.
研究类型
介入性
注册 (实际的)
509
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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Tennessee
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Memphis、Tennessee、美国、38105
- St . Jude Children's Research Hospital
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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
25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:
- Childhood Cancer Survivor Study (CCSS) cohort participants
- Age 25 years or older
- No CV screening in previous 5 years
- Received anthracycline chemotherapy and/or irradiation of the chest
- Previous history of successful independent (non-surrogate) response to CCSS surveys (reading level for non-medical items is 4th-6th grade Flesch-Kincaid level).
Exclusion Criteria:
- Being followed at an institution actively recruiting adults to a long-term follow-up program (ascertained in CCSS follow-up database)
- Inability or unwillingness of research participant to give written informed consent.
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：放映
- 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 |
|---|---|
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其他：Control Arm
Control arm will receive standard care for risk of cardiac sequelae - a mailed, tailored (neither generic nor targeted) print summary of individualized information about the survivor's treatment, late effects risks, and recommended follow-up and lifestyle modifications.
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A mailed individualized cancer treatment summary with recommendations for CV follow-up and lifestyle modification (standard care).
其他名称：
Standard care plus motivational, autonomy-supportive APN counseling (2 phone sessions) that targets two categories of behavioral constructs likely to influence screening.
其他名称：
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其他：Test Arm
Test arm will receive standard care plus motivational, autonomy-supportive APN counseling (2 phone sessions) that targets two categories of behavioral constructs likely to influence screening.
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A mailed individualized cancer treatment summary with recommendations for CV follow-up and lifestyle modification (standard care).
其他名称：
Standard care plus motivational, autonomy-supportive APN counseling (2 phone sessions) that targets two categories of behavioral constructs likely to influence screening.
其他名称：
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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 |
|---|---|
|
This study will test the hypothesis that at 1 year post-intervention, a significantly greater proportion of the APN phone counseling group will have undergone cardiovascular screening, as compared to the standard care group
大体时间：2.5 years
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2.5 years
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change in knowledge
大体时间：Baseline and 2.5 years post intervention
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Baseline and 2.5 years post intervention
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Change in motivation
大体时间：Baseline and 2.5 years post intervention
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Baseline and 2.5 years post intervention
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Change in fear
大体时间：Baseline and 2.5 years post intervention
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Baseline and 2.5 years post intervention
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Change in beliefs
大体时间：Baseline and 2.5 years post intervention
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Baseline and 2.5 years post intervention
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Change in affect
大体时间：Baseline and 2.5 years post intervention
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Baseline and 2.5 years post intervention
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Change in readiness for medical follow-up
大体时间：Baseline and 2.5 years post intervention
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Baseline and 2.5 years post intervention
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Change in self-efficacy
大体时间：Baseline and 2.5 years post intervention
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Baseline and 2.5 years post intervention
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Estimated average cost of intervention per participant
大体时间：2.5 years
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2.5 years
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Estimated average cost of standard care per participant in the Control Arm
大体时间：2.5 years
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2.5 years
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Estimated average cost of cardiovascular screening per participant in the Test Arm
大体时间：2.5 years
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2.5 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：Melissa Hudson, MD、St. Jude Children's Research Hospital
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
2010年3月1日
初级完成 (实际的)
2013年7月1日
研究完成 (实际的)
2013年7月1日
研究注册日期
首次提交
2009年10月27日
首先提交符合 QC 标准的
2009年10月28日
首次发布 (估计)
2009年10月29日
研究记录更新
最后更新发布 (估计)
2013年11月26日
上次提交的符合 QC 标准的更新
2013年11月25日
最后验证
2013年11月1日
更多信息
与本研究相关的术语
其他研究编号
- ECHOS
- R01NR011322 (美国 NIH 拨款/合同)
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.