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Improving Symptom Management for Cancer Patients and Their Caregivers Through Internet

27 de octubre de 2015 actualizado por: Oslo University Hospital

Improving Symptom Management for Cancer Patients and Their Caregivers Through Internet Support: A Randomized Clinical Trial

Being diagnosed and treated for cancer is usually associated with severe side effects and symptoms. Cancer patients can have difficulty to manage the symptoms as a result of treatment which may cause i) an interruption or cessation of cancer treatment ii) can have a negative impact on patients' quality of life (QoL). Family caregivers (FCs) of cancer patients are often the primary source of social and emotional support for patients, and play major roles in how well patients manage with the consequences of illness and treatment. Thus, FCs are clinically important, since supporting FCs indirectly supports patients.

To help both cancer patients and their FCs to manage their symptoms, our center has developed WebChoice now called Connect, an internet based support system that extends traditional health services into cancer patients' homes. Connect provides individualized symptom management support, illness relevant information, and communication with a clinical nurse specialist in cancer care, as well as with other cancer patients and their FCs over the Internet. The objectives of this interdisciplinary research project are to test main and interaction effects of providing Connect to patients, to FCs or both simultaneously on 1) primary patient outcomes in terms of symptom distress, QoL, depression, fatigue and sleep 2) Primary FC outcomes in terms of symptom distress, QoL, depression, fatigue, sleep and FC burden 3) Secondary, or intermediate, patient and FC outcomes in terms of self-efficacy social support, and self-reported health care utilization.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Cancer patients often experience multiple symptoms due to the illness itself and its treatment. Failure to detect and relieve patients' symptoms can have deleterious effects on patients [1]. To adequately help patients, it is important to understand how symptoms vary and co-vary during different phases of patients' illness trajectory. A major limitation in previous studies of symptoms in patients undergoing cancer treatment is that they have not evaluated symptom changes over time during and how changes in one or more symptom influence patients QoL. Furthermore, compelling evidence exist that cancer patients do not receive adequate symptom management or palliative care during the course of their illness [2-4].

A barrier to appropriate symptom management is the lack of interventions that support patients effectively in symptom management and self-management. Within the current health system, patients get limited help with their symptoms and health problems. This problem is accentuated by short hospital stays or consultations. Side-effects of treatment usually are at their worst after discharge from the hospital, and patients spend most of the time at home, leaving them with considerable symptom distress without much assistance. To overcome these problems, the Center for Shared Decision Making (CSDM) and Collaborative Care Research at Olso University Hospital (OUS) has developed WebChoice now called Connect, an Internet based support system that extends traditional health services into cancer patients' homes. Connect provides individualized symptom management support, illness relevant information, and communication with a clinical nurse specialist (CNS) in cancer care, as well as with other cancer patients over the Internet. v has been tested in an RCT funded by the Norwegian Cancer Society with breast and prostate cancer patients nationwide. Results from this RCT and other previous studies on Connect components demonstrate significant improvements in patient-centered care [5-7] and patient outcomes in terms of less symptom distress of depression. Also patients with access to WebChoice maintained self-efficacy and health related quality of life over time while the control group deteriorated significantly. (under review). Therefore, an important next step and aim of this study is to expand and test Connect in the following, to benefit a larger group of patients.

Research has repeatedly shown that FCs of cancer patients experience many problems, symptoms and burden [8]. However, the relationship between patient and FCs symptoms and problems is not yet sufficiently understood. Affecting one may also affect the other, and interventions that support FCs could also support patients and vice versa, reducing symptom distress [9]. Therefore, we will extend Connect to support cancer patients and their FCs, and test its effects on patient and FC outcomes.

Thus the specific aims for Phase II of this project are to:

1. Develop and test the effects of an extended Connect module to support (1) cancer patients and (2) their FCs on patient and FC outcomes.

Research Questions:

Following cancer patients and their FCs with 3 repeated measures over 6 months, this study will test main and interaction effects of providing Connect to patients, to FCs or both simultaneously on:

  • Primary patient outcomes in terms of symptom distress, HRQoL, depression, fatigue and sleep.
  • Primary FC outcomes in terms of symptom distress, QoL, depression, fatigue, sleep and care giver burden.
  • Secondary, or intermediate, patient and FC outcomes in terms of self-efficacy, social support, and self-reported health care utilization.
  • To better understand how these effects may occur, we will explore relationships between primary patient and FC outcomes; and how primary and secondary outcomes vary and co-vary across experimental conditions. Additional research questions are:
  • How do patients and FCs use Connect? What is the frequency of use and which components are most used?
  • What are patients' and FCs perceptions of usefulness and ease of use of Connect?

Tipo de estudio

Intervencionista

Inscripción (Actual)

560

Fase

  • Fase 1

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

      • Oslo, Noruega, 4950
        • Oslo University Hospital

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 a 90 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • diagnosed and treated for cancer;
  • > 18 years of age,
  • able to read/write/speak Norwegian,
  • written informed consent, and
  • have a FC who is willing to participate. FCs will be the individual the patient identifies as being most involved in their care.

Exclusion Criteria:

  • Patients received cranial radiation or who have brain metastasis

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: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Internet communication application
Experiment 1 Effect of internet support program on cancer patients and their caregivers
Intervention 1 Effect of internet support program will be tested on cancer patients and their family caregivers No intervention
Sin intervención: Control group
Control group get usual care

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Change from the Baseline in severity and duration of HRQoL
Periodo de tiempo: Baseline, 3 og 6 months
Baseline, 3 og 6 months
Change from the baseline in severity and duration of depression
Periodo de tiempo: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change from the Baseline in severity and duration of fatigue
Periodo de tiempo: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change from the baseline in severity and duration of sleep disorder
Periodo de tiempo: Baseline, 3 and 6 months
Baseline, 3 and 6 months

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Change from baseline in self-efficacy
Periodo de tiempo: Baseline and at 3 and 6 months
Baseline and at 3 and 6 months
Change from baseline in social support
Periodo de tiempo: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change from baseline in self-reported health care utilization
Periodo de tiempo: Baseline, 3 and 6 months
Baseline, 3 and 6 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Cornelia Ruland, PHD, Oslo University Hospital- Raikshospitalet

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 abril de 2012

Finalización primaria (Actual)

1 de octubre de 2014

Finalización del estudio (Actual)

1 de enero de 2015

Fechas de registro del estudio

Enviado por primera vez

6 de marzo de 2012

Primero enviado que cumplió con los criterios de control de calidad

29 de mayo de 2013

Publicado por primera vez (Estimar)

4 de junio de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

28 de octubre de 2015

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

27 de octubre de 2015

Última verificación

1 de octubre de 2015

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 6.2008.547

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 Internet communication application

3
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