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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
284
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Connecticut
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Hartford、Connecticut、アメリカ、06102
- Harry Gray Cancer Center at Hartford Hospital
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Illinois
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Chicago、Illinois、アメリカ、60612
- University of Illinois at Chicago Cancer Center
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Texas
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Houston、Texas、アメリカ、77030
- M.D. Anderson Cancer Center
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Wisconsin
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Madison、Wisconsin、アメリカ、53792
- University of Wisconsin Carbone Cancer Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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アクティブコンパレータ：Usual care with Internet access
Control group patients will be given a list of URLs for 10-high quality lung cancer-related sites
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life.
時間枠：12-month intervention
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12-month intervention
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Compared to a Usual Care control, CHESS will significantly improve patient influence length of survival of lung cancer patient.
時間枠：12-month intervention
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12-month intervention
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Examine the effects of CHESS use on self-determination theory (SDT) constructs.
時間枠：12 mos.
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12 mos.
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Examine the factors that moderate effect of CHESS use on self-determination theory (SDT) constructs.
時間枠：12 mos.
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12 mos.
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Examine whether these constructs mediate the effects of CHESS use on patient quality of life.
時間枠：12 mos.
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12 mos.
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Examine whether treatment participation mediates the effect patient quality of life has on survival.
時間枠：12 mos/
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12 mos/
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：James Cleary, M.D.、University of Wisconsin, Madison
- 主任研究者：Lori DuBenske, Ph.D.、University of Wisconsin, Madison
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2009年11月1日
一次修了 (実際)
2014年5月15日
研究の完了 (実際)
2014年5月15日
試験登録日
最初に提出
2009年11月10日
QC基準を満たした最初の提出物
2009年11月12日
最初の投稿 (見積もり)
2009年11月13日
学習記録の更新
投稿された最後の更新 (実際)
2019年11月15日
QC基準を満たした最後の更新が送信されました
2019年11月13日
最終確認日
2019年3月1日
詳しくは
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