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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01779063
Promoting Adherence to Lymphedema Self-care
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
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37072
- Vanderbilt Univeristy School Of Nursing
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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:
- have a history of breast cancer;
- previous diagnosis of lymphedema;
- 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);
- be age 18 or older;
- be able to see and read printed documents in English; and for stage 2 only,
- have access to the Internet or a smart phone.
Exclusion Criteria: will not be:
- undergoing chemotherapy or radiation, or
- receiving hospice care. Additional exclusion criteria for local participants undergoing bioelectrical impedance measurements: pregnancy, metal implants, and defibrillator implants.
Plan de estudios
¿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
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cognitive therapy based web intervention
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Comparador activo: education booklet
printed educational booklet
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patient education booklet
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¿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
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self-report of symptoms will be documented on study instruments
|
change between baseline and 1, 3, 6, and 12 months post-intervention
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function
Periodo de tiempo: change between baseline and 1, 3, 6, and 12 months post-intervention
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Self-report functional data using a validated instrument
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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
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change between baseline and 3, 6, and 12 months post-intervention
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 124137-RSG-13-022-01-CPPB
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