Evaluating an Interactive Cancer Communication System (ICCS) in Lung Cancer
13 de noviembre de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
284
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Connecticut
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Hartford, Connecticut, Estados Unidos, 06102
- Harry Gray Cancer Center at Hartford Hospital
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- University of Illinois at Chicago Cancer Center
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Texas
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Houston, Texas, Estados Unidos, 77030
- M.D. Anderson Cancer Center
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin Carbone Cancer Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life.
Periodo de tiempo: 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.
Periodo de tiempo: 12-month intervention
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12-month intervention
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Examine the effects of CHESS use on self-determination theory (SDT) constructs.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 12 mos/
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12 mos/
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: James Cleary, M.D., University of Wisconsin, Madison
- Investigador principal: Lori DuBenske, Ph.D., University of Wisconsin, Madison
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de noviembre de 2009
Finalización primaria (Actual)
15 de mayo de 2014
Finalización del estudio (Actual)
15 de mayo de 2014
Fechas de registro del estudio
Enviado por primera vez
10 de noviembre de 2009
Primero enviado que cumplió con los criterios de control de calidad
12 de noviembre de 2009
Publicado por primera vez (Estimar)
13 de noviembre de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de noviembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
13 de noviembre de 2019
Última verificación
1 de marzo de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- M-2009-1223
- 2P50CA095817-06 (Subvención/contrato del NIH de EE. UU.)
- XP08517 (Otro identificador: University of Wisconsin, Madison)
- NCI-2011-01004 (Identificador de registro: NCI Trial ID)
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