- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00983892
Care Partners: Web-based Support for Caregivers of Veterans Undergoing Chemotherapy
Web-based Support for Caregivers of Veterans Undergoing Chemotherapy
Descripción general del estudio
Descripción detallada
Cancer is a prevalent problem that causes much suffering among Veterans and their families. Most interventions to improve symptom control require Veterans to engage in activities such as managing medications, altering diets, or accessing outside resources that may be beyond their reach due to limitations in physical and mental functioning. Friends and family inside and outside of the Veteran's household can help, but often lack the skills and resources they need to do so.
"Cancer CarePartners" was designed to address these needs by providing cancer-stricken Veterans and their informal caregivers with the information they need to make effective management decisions, decrease symptom burden, and improve outcomes. Cancer CarePartners is a Web-enabled program that alerts caregivers of patients' symptoms and provides them with a framework for identifying problems, receiving structured advice, formulating a 'task list,' and following up with their patients as they receive chemotherapy. Specifically, Cancer CarePartners includes weekly, automated telephonic symptom assessment (ATSA) with self-management (SM) support to the Veteran paired with Web-based alerts to the caregiver pointing them to a website where s/he can obtain customized advice. A randomized control trial was conducted to test the efficacy of this program in controlling symptoms as well as improving adherence to chemotherapy.
Objectives
1) To determine if Veterans undergoing chemotherapy who receive Cancer CarePartners report significant improvement in the summed severity of symptoms (the sum of 0-10 severity across 8 core symptoms) compared to Veterans receiving symptom monitoring and self-management advice; secondarily, to determine if they experience better adherence to chemotherapy and utilization. (2) To determine if caregivers participating in the intervention provide significantly more social support to patients than do controls; secondarily, to determine if they experience more caregiver burden and distress than do controls. (3) To determine whether impacts on patients are mediated by mastery. (4) To determine whether impacts on caregivers are mediated by mastery.
Methods Consenting Veterans with solid tumors undergoing chemotherapy at one of three VAMCs (Ann Arbor, Loma Linda and Fargo) who reported at least one core symptom at a moderate level or higher and had a caregiver willing to enroll in the study were randomly assigned to either 10 weeks of Cancer CarePartners or 10 weeks of automated, telephonic symptom assessment (ATSA) with self management support. Arms were balanced for non-small cell lung cancer status and caregiver type. Patients and caregivers were surveyed at intake, 10, and 14 weeks. In addition, the investigators tracked patient participation with ATSA and (in the experimental arm) caregiver use of the Cancer CarePartners Website. The investigators reviewed all medical records for content of care received during the 14 weeks on study.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Loma Linda, California, Estados Unidos, 92357
- VA Loma Linda Healthcare System, Loma Linda, CA
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients must be 18 years or older, cognitively intact, English-speaking, able to hear, and own a telephone.
- Patients can have any solid tumor.
- Patients must be initiating IV cytotoxic chemotherapy and, if recurrent, have experienced a 1 month treatment free interval.
- Caregivers must be 18 years or older, cognitively intact, English-speaking, and able to hear/speak for interviews.
- Caregivers must have access to a telephone and computer with high speed internet access.
Exclusion Criteria:
- Patients will be excluded if they have a hematologic malignancy or are receiving bone marrow transplantation.
- Patients and caregivers will be excluded if they have an untreated serious mental illness or cognitive impairment, are institutionalized or enrolled in hospice (prior to trial), or plan on not receiving all care from VA
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: CarePartners+
Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive the intervention (Intervention = access to a caregiver Web site that updates them on patient's symptoms and provides tailored problem solving advice).
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Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan.
Otros nombres:
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Sin intervención: CarePartners-
Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing (i.e.
no access to the caregiver website, or 'intervention').
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Summed Symptom Severity
Periodo de tiempo: 3 months
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Summed severity across 8 symptoms of interest, as measured using the MD Anderson Symptom Inventory.
8 core symptoms rated by the patient on a scale of 0 to 10.
These 8 symptoms were chosen based on their prevalence of 50% or greater in the population of interest.
Higher scores mean WORSE or GREATER SYMPTOM BURDEN.
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3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Maria J. Silveira, MD MA MPH, VA Ann Arbor Healthcare System, Ann Arbor, MI
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IIR 08-309
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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