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临床试验/NCT00784095
NCT00784095已完成不适用

Outlook: An Intervention to Improve Quality of Life in Serious Illness

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Quality of Life - Preparation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with advanced cancer, CHF or COPD.

排除标准

  • Cognitive impairment, inability to speak, non-English speaking

结局指标

主要结局

Quality of Life - Preparation

时间窗: Baseline, 6 and 8 week follow up

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.

QUAL-E Completion Sub-scale

时间窗: Baseline, 6 and 8 week follow up

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.

次要结局

  • Functional Status ADL(Baseline, 6 and 8 week follow ups)
  • Center for Epidemiology Studies - Depression Scale (CES-D)(Baseline, 6 and 8 week follow up)
  • POMS Anxiety Sub-scale(Baseline, 6 and 8 week follow ups)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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Outlook Quality of Life Intervention | 临床试验