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临床试验/NCT01012401
NCT01012401已完成不适用

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

University of Wisconsin, Madison8 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2009年11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
284
试验地点
8
主要终点
Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • 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
  • 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.

排除标准

  • 未提供

结局指标

主要结局

Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life.

时间窗: 12-month intervention

Compared to a Usual Care control, CHESS will significantly improve patient influence length of survival of lung cancer patient.

时间窗: 12-month intervention

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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