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Care Partners: Web-based Support for Caregivers of Veterans Undergoing Chemotherapy

29 de febrero de 2016 actualizado por: VA Office of Research and Development

Web-based Support for Caregivers of Veterans Undergoing Chemotherapy

Given the growing strain on the Veterans Administration resulting from increasing caseloads of cancer patients, interventions are badly needed that assist patients in managing their illness, improve quality of life and avoid acute episodes that result in urgent care use and increased mortality. Previous studies have found that cancer patients undergoing chemotherapy can effectively manage their own symptoms when monitored using automated telephone calls. Such technology, however, may challenge the number of Veterans who lack social support and/or independence. The goal was to develop and test a technology that not only monitors patients automatically by telephone, but also gives them self management advice and engages a friend or family member to serve as a CarePartner willing to play a limited role in identifying patient symptoms and psychosocial needs to reinforce self management and provide social support. The investigators found that this technology indeed helped patients better control their symptoms, especially when a caregiver participated in the program along with them.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

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

Intervencionista

Inscripción (Actual)

134

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

    • California
      • Loma Linda, California, Estados Unidos, 92357
        • VA Loma Linda Healthcare System, Loma Linda, CA
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48105
        • VA Ann Arbor Healthcare System, Ann Arbor, MI

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:

  • 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

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 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).
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:
  • Care Partners
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').

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Summed Symptom Severity
Periodo de tiempo: 3 months
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.
3 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Maria J. Silveira, MD MA MPH, VA Ann Arbor Healthcare System, Ann Arbor, MI

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.

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

1 de octubre de 2009

Finalización primaria (Actual)

1 de abril de 2014

Finalización del estudio (Actual)

1 de febrero de 2015

Fechas de registro del estudio

Enviado por primera vez

22 de septiembre de 2009

Primero enviado que cumplió con los criterios de control de calidad

23 de septiembre de 2009

Publicado por primera vez (Estimar)

24 de septiembre de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

22 de marzo de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

29 de febrero de 2016

Última verificación

1 de febrero de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IIR 08-309

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

Ensayos clínicos sobre Cáncer

Ensayos clínicos sobre Caregiver website

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