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Promoting Adherence to Lymphedema Self-care

7 de abril de 2017 actualizado por: Sheila Ridner, Vanderbilt University

Promoting Adherence to Lymphedema Self-care in Breast Cancer Survivors

Lymphedema is a chronic condition that causes physical and emotional challenges to breast cancer survivors. As a progressive condition, lymphedema can result in swelling/fibrosis that can impair function, promote infection, and cause discomfort and emotional distress. Daily self-care that is required to manage lymphedema is time-consuming, burdensome, and lifelong. Previous studies found that about half of breast cancer survivors with lymphedema do not complete self-care as directed. Feelings of being helpless to manage the condition, a desire to be normal, lack of noticeable results from self-care, and poor social/healthcare professional support are barriers to performing self-care on a regular basis. There is a need to develop and test interventions to promote effective self-care. Experts suggest the best self-care interventions should include patient perspectives and be available a readily accessible format. Technological advancements support use of innovative, creative approaches, such as Web-based multimedia interventions. Web-based interventions can be used in rural and urban settings. The investigators are proposing to develop a Web-based, multimedia intervention and a "take home" manual to support self-care in breast cancer survivors with lymphedema. The investigators plan to conduct focus groups with these survivors to determine the content and delivery format(s) and to help us identify breast cancer survivors with lymphedema for the video component. The investigators will then develop an intervention that will include self-care demonstrations and other supportive information to help patients to cope with the challenges of self-care. The focus groups will reconvene, review the intervention, and give us feedback on modifying and refining the intervention. After finalizing the intervention, The investigators will recruit more breast cancer survivors with lymphedema and provide one half of them an education booklet and the other half the Web-based intervention (or an alternative format such as DVD). Then, over 12 months, the investigators will periodically assess and compare both groups on self-care behaviors, physical and emotional concerns, and other issues such as money spent on lymphedema treatment. The group that receives the education booklet will be given access to the Web-based intervention after the 12 month follow-up is done, but the investigators will not ask them to complete any more forms.

This project builds upon the investigators prior work that has provided information about lymphedema self-care problems and the investigators previous experience in developing patient education videos and manuals. By providing accessible, detailed self-care instructions and a psychosocial component, this intervention has the potential to improve lymphedema self-care. If successful, this intervention can be offered to the larger national and international community of breast cancer survivors with lymphedema.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

160

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

    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37072
        • Vanderbilt Univeristy School Of Nursing

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:

  1. have a history of breast cancer;
  2. previous diagnosis of lymphedema;
  3. Stage II lymphedema based upon International Society of Lymphedema (the limb is firm in places, elevation does not reduce swelling, it may or may not pit with pressure, and skin changes may be noted);
  4. be age 18 or older;
  5. be able to see and read printed documents in English; and for stage 2 only,
  6. have access to the Internet or a smart phone.

Exclusion Criteria: will not be:

  1. undergoing chemotherapy or radiation, or
  2. receiving hospice care. Additional exclusion criteria for local participants undergoing bioelectrical impedance measurements: pregnancy, metal implants, and defibrillator implants.

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
Experimental: web based multimedia intervention
interactive,web based multimedia intervention
cognitive therapy based web intervention
Comparador activo: education booklet
printed educational booklet
patient education booklet

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
symptom burden
Periodo de tiempo: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report of symptoms will be documented on study instruments
change between baseline and 1, 3, 6, and 12 months post-intervention
function
Periodo de tiempo: change between baseline and 1, 3, 6, and 12 months post-intervention
Self-report functional data using a validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention
psychological well-being
Periodo de tiempo: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report using a validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
coping
Periodo de tiempo: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report using validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention
self-care activities
Periodo de tiempo: Change between baseline 1, 3, 6, and 12 months post-intervention
self report using a self-care checklist
Change between baseline 1, 3, 6, and 12 months post-intervention
stress
Periodo de tiempo: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report using a validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention
self-efficacy
Periodo de tiempo: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report using a validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention
social support
Periodo de tiempo: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report using a validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention
extracellular fluid
Periodo de tiempo: change between baseline and 3, 6, and 12 months post-intervention
bioelectrical impedence measurement for sub set of participants
change between baseline and 3, 6, and 12 months post-intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este 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 enero de 2013

Finalización primaria (Actual)

1 de diciembre de 2016

Finalización del estudio (Actual)

1 de diciembre de 2016

Fechas de registro del estudio

Enviado por primera vez

23 de enero de 2013

Primero enviado que cumplió con los criterios de control de calidad

25 de enero de 2013

Publicado por primera vez (Estimar)

30 de enero de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de abril de 2017

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

7 de abril de 2017

Última verificación

1 de abril de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 124137-RSG-13-022-01-CPPB

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 web based multimedia intervention

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