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Evaluating an Interactive Cancer Communication System (ICCS) in Lung Cancer

2019年11月13日 更新者：University of Wisconsin, Madison

Interactive Cancer Communication System (ICCS) in Lung Cancer: Evaluating Survival Benefits. Center of Excellence in Cancer Communication Research: Using Technology to Enhance Cancer Communication and Improve Clinical Outcomes

This study will examine the potential for an Interactive Cancer Communication System (ICCS) to impact not only psychosocial outcomes such as quality of life but also length of survival in an advanced stage lung cancer population. Two hypotheses will be tested: the Comprehensive Health Enhancement Support System- Lung Cancer (CHESS- LC) will significantly improve patient quality of life and length of overall survival as compared to a usual care control group.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The prognosis for Non-Small Cell Lung Cancer patients remains poor despite recent advances in anti-cancer therapies. A lung cancer diagnosis often inflicts fear, despair, and hopelessness on patients and loved ones. For lung cancer patients in particular, a population where palliation rather than cure is often the focus, interventions addressing communication about various types of suffering are crucial to quality of life (QOL). Our Center has done extensive research testing CHESS (Comprehensive Health Enhancement Support System), a non-commercial, web-based information and support system. The recent Clinician Integration Project tested the impact of CHESS versus an Internet only Control group on QOL for caregivers of advanced stage lung cancer patients. This study yielded an unanticipated finding that CHESS may have a survival benefit for patients as one year survival was significantly increased in the CHESS group (50%) compared to Internet (34.2%). As this project did not focus on patient outcomes, follow-up with a well-formulated study designed and powered to address specific hypotheses of the nature of this effect is critical. The proposed study will specifically test QOL and survival effects of CHESS on lung cancer patients. Using sites in Wisconsin, Connecticut,Houston, and Chicago, we will randomly assign 376 advanced lung cancer patients to two study arms: a patient control group receiving Usual Care (including access to a computer and Internet) and a group given access to the CHESS website. Patients may invite a caregiver to participate. Patients will be followed for 18 months or until patient death.

研究类型

介入性

注册 (实际的)

284

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

  • 美国
    • Connecticut
      • Hartford、Connecticut、美国、06102
        • Harry Gray Cancer Center at Hartford Hospital
    • Illinois
      • Chicago、Illinois、美国、60612
        • University of Illinois at Chicago Cancer Center
    • Texas
      • Houston、Texas、美国、77030
        • M.D. Anderson Cancer Center
    • Wisconsin
      • Madison、Wisconsin、美国、53792
        • University of Wisconsin Carbone Cancer Center

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:

  • All patients must be diagnosed with non-small cell lung cancer (Stage IIIA non surgical, IIIB or IV)
  • All patients must be within 12 months of their primary lung cancer diagnosis or metastatic or recurrence disease.
  • All patients must be at least 18 years of age,
  • All patients must have an ECOG Performance Status rating of level 0, 1 or 2.
  • If patients have brain metastases, they must be stable
  • All patients must be under the care of a clinician who has consented to participate in the study.
  • All patients must be able to speak and read English (educational attainment of at least 6th grade).
  • All patients will be invited to have a caregiver also participate in the study, however this is not required.

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
实验性的：CHESS with Clinician Report + Internet access
An Internet-based system, Comprehensive Health Enhancement Support System for Lung Cancer(CHESS-LC) integrates over 14 services to provide tailored cancer information, support, and interactive tools.
其他：CHESS website for lung cancer patient + internet access if needed
The Comprehensive Health Enhancement Support System (CHESS), a non-commercial, home-based system created by clinical, communication, and decision scientists at the University of Wisconsin, is distinguished by its quality, depth, and ease of use. It employs data on user health status to help users monitor their condition, guide them to tailored information and social support, make and implement important health decisions, and learn coping skills. Our tests and clinical trials demonstrate that an ICCS such as CHESS can be widely accepted and used, improve quality of life, information competence, and in some cases lead to more efficient use of health services. An Internet-based system, CHESS-LC integrates over 14 services to provide tailored cancer information, support, interactive tools, and communication with the clinical team.
有源比较器：Usual care with Internet access
Control group patients will be given a list of URLs for 10-high quality lung cancer-related sites
其他：CHESS website for lung cancer patient + internet access if needed
The Comprehensive Health Enhancement Support System (CHESS), a non-commercial, home-based system created by clinical, communication, and decision scientists at the University of Wisconsin, is distinguished by its quality, depth, and ease of use. It employs data on user health status to help users monitor their condition, guide them to tailored information and social support, make and implement important health decisions, and learn coping skills. Our tests and clinical trials demonstrate that an ICCS such as CHESS can be widely accepted and used, improve quality of life, information competence, and in some cases lead to more efficient use of health services. An Internet-based system, CHESS-LC integrates over 14 services to provide tailored cancer information, support, interactive tools, and communication with the clinical team.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life.
大体时间：12-month intervention
12-month intervention
Compared to a Usual Care control, CHESS will significantly improve patient influence length of survival of lung cancer patient.
大体时间：12-month intervention
12-month intervention

次要结果测量

结果测量
大体时间
Examine the effects of CHESS use on self-determination theory (SDT) constructs.
大体时间：12 mos.
12 mos.
Examine the factors that moderate effect of CHESS use on self-determination theory (SDT) constructs.
大体时间：12 mos.
12 mos.
Examine whether these constructs mediate the effects of CHESS use on patient quality of life.
大体时间：12 mos.
12 mos.
Examine whether treatment participation mediates the effect patient quality of life has on survival.
大体时间：12 mos/
12 mos/

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。

赞助

University of Wisconsin, Madison

合作者

M.D. Anderson Cancer Center
National Cancer Institute (NCI)
University of Illinois at Chicago
Hartford Hospital

调查人员

  • 首席研究员：James Cleary, M.D.、University of Wisconsin, Madison
  • 首席研究员：Lori DuBenske, Ph.D.、University of Wisconsin, Madison

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。

有用的网址

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 (实际的)

2009年11月1日

初级完成 (实际的)

2014年5月15日

研究完成 (实际的)

2014年5月15日

研究注册日期

首次提交

2009年11月10日

首先提交符合 QC 标准的

2009年11月12日

首次发布 (估计)

2009年11月13日

研究记录更新

最后更新发布 (实际的)

2019年11月15日

上次提交的符合 QC 标准的更新

2019年11月13日

最后验证

2019年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • M-2009-1223
  • 2P50CA095817-06 (美国 NIH 拨款/合同)
  • XP08517 (其他标识符：University of Wisconsin, Madison)
  • NCI-2011-01004 (注册表标识符：NCI Trial ID)

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.

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