Outlook Quality of Life Intervention
2016年3月11日 更新者：VA Office of Research and Development
Outlook: An Intervention to Improve Quality of Life in Serious Illness
The purpose of this study is to determine whether discussions of life story, forgiveness, and future goals improve quality of life for patients with serious illness.
研究概览
详细说明
This is a pilot randomized control trial to evaluate the feasibility of the Outlook intervention.
36 veterans with advanced cancer, congestive heart failure (CHF) or chronic obstructive pulmonary disease (COPD) will be randomly assigned to one of three intervention groups and complete a brief battery of pre-test measures.
Subjects in the first group ("treatment") will meet with a facilitator three times for a period of 45 min-1 hour.
In the first session, subjects will be asked to discuss issues related to life review.
In the second session, participants will be asked to speak in more depth about issues such as regret, forgiveness and things left undone, In the final session, subjects will focus on heritage and legacy.
The subjects in the second group ("attention control") will meet with a facilitator three times for a period of 45 min- 1 hour and listen to a non-guided relaxation compact disk (CD).
The third group of participants ("true control") will be exposed to no intervention or attention control.
One week and two weeks later, participants in all groups will receive post-test measures administered by a blinded interviewer.
研究类型
介入性
注册 (实际的)
36
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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North Carolina
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Durham、North Carolina、美国、27705
- Durham VA Medical Center HSR&D COE
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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 with advanced cancer, CHF or COPD.
Exclusion Criteria:
Cognitive impairment, inability to speak, non-English speaking
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
- 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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有源比较器：注意力控制
第二组（“注意力控制”）中的受试者与辅导员会面 3 次，持续 45 分钟，并听了一张无指导的放松 CD。
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Subjects will listen to a non-guided relaxation CD.
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实验性的：Preparation and Completion
Subjects in the first group ("treatment") met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation.
In the first session, subjects were asked to discuss issues related to life review.
In session two, participants spoke about issues of regret and forgiveness.
In the final session, subjects discussed issues of heritage and legacy.
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Subjects will discuss life review, issues of forgiveness and heritage and legacy.
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无干预：True Control
Subjects in the third group ("true control") were exposed to no intervention or attention control.
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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 |
|---|---|---|
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Quality of Life - Preparation
大体时间：Baseline, 6 and 8 week follow up
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Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support.
The 4-item preparation sub-scale is a primary outcomes measure with each item scaled from 1 to 5 with a minimum of 5, maximum of 20 score with higher scores indicating better preparation.
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Baseline, 6 and 8 week follow up
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QUAL-E Completion Sub-scale
大体时间：Baseline, 6 and 8 week follow up
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A sub-scale of the QUAL-E quality of life at the end of life measures.
The scale range was 5-35 with higher scores indicating more positive sense of completion.
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Baseline, 6 and 8 week follow up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Functional Status ADL
大体时间：Baseline, 6 and 8 week follow ups
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Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability.
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Baseline, 6 and 8 week follow ups
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Center for Epidemiology Studies - Depression Scale (CES-D)
大体时间：Baseline, 6 and 8 week follow up
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Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression.
Items are rated on a 4 point likert scale with total scores ranging from 0-30.
Higher scores indicate greater depressive symptoms.
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Baseline, 6 and 8 week follow up
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POMS Anxiety Sub-scale
大体时间：Baseline, 6 and 8 week follow ups
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The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 5-25.
Higher scores indicate greater anxiety.
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Baseline, 6 and 8 week follow ups
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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：Karen E. Steinhauser, PhD、Durham VA Medical Center HSR&D COE
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
2008年12月1日
初级完成 (实际的)
2009年5月1日
研究完成 (实际的)
2009年5月1日
研究注册日期
首次提交
2008年10月30日
首先提交符合 QC 标准的
2008年10月30日
首次发布 (估计)
2008年11月2日
研究记录更新
最后更新发布 (估计)
2016年3月22日
上次提交的符合 QC 标准的更新
2016年3月11日
最后验证
2016年3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.