Improvement of Information to Cancer Patients' Caregivers
18 de enero de 2019 actualizado por: Mogens Groenvold, Bispebjerg Hospital
Improvement of Information to Cancer Patients' Caregivers: a Randomised Intervention Study
The purpose of this study is to investigate whether a systematic early assessment of uncovered needs for information, supplemented by an interview about the needs with the patient's nurse who seeks to provide the information requested, will improve the caregivers' and the patients' satisfaction with information and communication and potentially also decrease anxiety and depression.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
211
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
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Herlev, Dinamarca, 2730
- Department of Oncology, Herlev Hospital
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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
Patient Inclusion Criteria:
- Cancer patient
- Newly refered to (i.e., this is the patient's first visit in) Department of Oncology, Herlev Hospital, in order to start medical treatment (e.g. chemotherapy)
- Written informed consent
Caregiver Inclusion Criteria:
- Attends the first visit in the Department of Oncology with the patient
- Has lacked information about at least one of the 13 aspects of information asked about in the questionnaire
- Written informed consent
Exclusion Criteria:
- Patient and/or caregiver do not understand Danish well enough to participate in the study
- The patient has an expected survival of less than six months
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 paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Immediate intervention
Immediately after enrollment in the project, caregivers and patients receive the intervention
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The intervention consists of an interview about the caregiver's responses (baseline measurement) to a list about 'lack of information' within 13 areas.
For each area, the patient's nurse will enquire about what information is requested by the caregiver and the patient.
Subsequently, the nurse provides the requested information.
She may involve the doctor and arrange follow-up visits or phone calls until the need is covered
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Otro: Delayed intervention (3 weeks later)
This group receives the same intervention as in the experimental group, but after the outcome assessment at 2 weeks
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The intervention consists of an interview about the caregiver's responses (baseline measurement) to a list about 'lack of information' within 13 areas.
For each area, the patient's nurse will enquire about what information is requested by the caregiver and the patient.
Subsequently, the nurse provides the requested information.
She may involve the doctor and arrange follow-up visits or phone calls until the need is covered
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Satisfaction with information from health care professionals
Periodo de tiempo: Change from baseline (enrollment) at 2 weeks
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Measure: The "Cancer Caregiving Tasks, Consequences and Needs Questionnaire" (CaTCoN) item 24
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Change from baseline (enrollment) at 2 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Satisfaction with information from health care professionals
Periodo de tiempo: Change from baseline (enrollment) at 2 weeks
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Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)
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Change from baseline (enrollment) at 2 weeks
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Satisfaction with communication with health care professionals
Periodo de tiempo: Change from baseline (enrollment) at 2 weeks
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Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"
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Change from baseline (enrollment) at 2 weeks
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Satisfaction with support from health care professionals
Periodo de tiempo: Change from baseline (enrollment) at 2 weeks
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Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers' wellbeing"
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Change from baseline (enrollment) at 2 weeks
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Satisfaction with support from health care professionals
Periodo de tiempo: Change from baseline (enrollment) at 2 weeks
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Measures: CaTCoN subscale "Need for help from health care professionals"
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Change from baseline (enrollment) at 2 weeks
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Anxiety and depression
Periodo de tiempo: Change from baseline (enrollment) at 2 weeks
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Measure: The Hospital Anxiety and Depression Scale (HADS)
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Change from baseline (enrollment) at 2 weeks
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Fulfillment of needs
Periodo de tiempo: Change from baseline (enrollment) at 2 weeks
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Measure: Family Inventory of Needs (FIN)
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Change from baseline (enrollment) at 2 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The time spent on information as reported by health care professionals
Periodo de tiempo: Weeks 0-6 from baseline
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Investigated in focus group interviews with the health care professionals
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Weeks 0-6 from baseline
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Satisfaction with information from health care professionals
Periodo de tiempo: Change from baseline (enrollment) at 12 weeks
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Measure: CaTCoN item 24
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Change from baseline (enrollment) at 12 weeks
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Satisfaction with information from health care professionals
Periodo de tiempo: Change from baseline (enrollment) at 12 weeks
|
Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)
|
Change from baseline (enrollment) at 12 weeks
|
|
Satisfaction with communication with health care professionals
Periodo de tiempo: Change from baseline (enrollment) at 12 weeks
|
Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"
|
Change from baseline (enrollment) at 12 weeks
|
|
Satisfaction with support from health care professionals
Periodo de tiempo: Change from baseline (enrollment) at 12 weeks
|
Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers' wellbeing"
|
Change from baseline (enrollment) at 12 weeks
|
|
Satisfaction with support from health care professionals
Periodo de tiempo: Change from baseline (enrollment) at 12 weeks
|
Measures: CaTCoN subscale "Need for help from health care professionals"
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Change from baseline (enrollment) at 12 weeks
|
|
Anxiety and depression
Periodo de tiempo: Change from baseline (enrollment) at 12 weeks
|
Measure: The Hospital Anxiety and Depression Scale (HADS)
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Change from baseline (enrollment) at 12 weeks
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Fulfillment of needs
Periodo de tiempo: Change from baseline (enrollment) at 12 weeks
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Measure: Family Inventory of Needs (FIN)
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Change from baseline (enrollment) at 12 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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.
Publicaciones Generales
- Lund L, Ross L, Petersen MA, Groenvold M. The interaction between informal cancer caregivers and health care professionals: a survey of caregivers' experiences of problems and unmet needs. Support Care Cancer. 2015 Jun;23(6):1719-33. doi: 10.1007/s00520-014-2529-0. Epub 2014 Nov 29.
- Lund L, Ross L, Groenvold M. The initial development of the 'Cancer Caregiving Tasks, Consequences and Needs Questionnaire' (CaTCoN). Acta Oncol. 2012 Nov;51(8):1009-19. doi: 10.3109/0284186X.2012.681697. Epub 2012 May 8.
- Lund L, Ross L, Petersen MA, Groenvold M. The validity and reliability of the 'Cancer Caregiving Tasks, Consequences and Needs Questionnaire' (CaTCoN). Acta Oncol. 2014 Jul;53(7):966-74. doi: 10.3109/0284186X.2014.888496. Epub 2014 Mar 16.
- Lund L, Ross L, Petersen MA, Sengelov L, Groenvold M. Improving information to caregivers of cancer patients: the Herlev Hospital Empowerment of Relatives through More and Earlier information Supply (HERMES) randomized controlled trial. Support Care Cancer. 2020 Feb;28(2):939-950. doi: 10.1007/s00520-019-04900-3. Epub 2019 Jun 8.
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 2015
Finalización primaria (Actual)
1 de mayo de 2016
Finalización del estudio (Actual)
1 de agosto de 2016
Fechas de registro del estudio
Enviado por primera vez
29 de enero de 2015
Primero enviado que cumplió con los criterios de control de calidad
2 de marzo de 2015
Publicado por primera vez (Estimar)
5 de marzo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
18 de enero de 2019
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- R82-A5445
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. .