Evaluating an Interactive Cancer Communication System (ICCS) in Lung Cancer
2019년 11월 13일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
284
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Connecticut
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Hartford, Connecticut, 미국, 06102
- Harry Gray Cancer Center at Hartford Hospital
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Illinois
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Chicago, Illinois, 미국, 60612
- University of Illinois at Chicago Cancer Center
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Texas
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Houston, Texas, 미국, 77030
- M.D. Anderson Cancer Center
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Wisconsin
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Madison, Wisconsin, 미국, 53792
- University of Wisconsin Carbone Cancer Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life.
기간: 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.
기간: 12-month intervention
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12-month intervention
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2차 결과 측정
결과 측정 |
기간 |
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Examine the effects of CHESS use on self-determination theory (SDT) constructs.
기간: 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.
기간: 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.
기간: 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.
기간: 12 mos/
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12 mos/
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: James Cleary, M.D., University of Wisconsin, Madison
- 수석 연구원: Lori DuBenske, Ph.D., University of Wisconsin, Madison
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2009년 11월 1일
기본 완료 (실제)
2014년 5월 15일
연구 완료 (실제)
2014년 5월 15일
연구 등록 날짜
최초 제출
2009년 11월 10일
QC 기준을 충족하는 최초 제출
2009년 11월 12일
처음 게시됨 (추정)
2009년 11월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 11월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 11월 13일
마지막으로 확인됨
2019년 3월 1일
추가 정보
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