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- Ensayo clínico NCT02427490
A Problem-Solving Intervention for Family Caregivers in Palliative Oncology
24 de octubre de 2021 actualizado por: Karla Washington, University of Missouri-Columbia
In congruence with the National Cancer Institute's commitment to supporting families of individuals with cancer across the full disease trajectory, the investigators seek to examine the feasibility of a technologically-mediated problem-solving intervention designed to improve the quality of life and decrease the psychological distress of family caregivers of cancer patients receiving outpatient palliative care.
Investigators involved in this mixed methods pilot study will collect and analyze both quantitative and qualitative data, which will subsequently inform a large-scale randomized clinical trial of the problem-solving intervention.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Palliative oncology providers are ideally situated to improve the cancer journey for the millions of family members and friends who are vital to the care of seriously ill patients.
In recent decades, the primary setting for cancer care has shifted from the hospital inpatient unit to the outpatient clinic, leaving family caregivers responsible for providing the majority of patient care in the home, often with little support or preparation.
The numerous stressors associated with family caregiving often give rise to caregiver anxiety, depression, fatigue, neglect of self-care and, for particularly strained caregivers, psychological symptoms that mirror those experienced by trauma survivors.
In congruence with the National Cancer Institute's commitment to supporting families of individuals with cancer across the full disease trajectory, the investigators seek to examine the feasibility of a technologically-mediated problem-solving intervention designed to improve the quality of life and decrease the psychological distress of family caregivers of cancer patients receiving outpatient palliative care.
Specifically, the investigators aim to 1) examine the feasibility of the intervention relative to recruitment, randomization, retention, and fidelity to core intervention components; 2) investigate the impact of the intervention on family caregiver anxiety, depression, and quality of life; and 3) explore the benefits and challenges associated with the intervention from the perspective of participants.
To accomplish these aims, investigators will recruit and randomly assign 82 family caregivers of cancer patients receiving outpatient palliative care into two groups (usual care and intervention) and collect quantitative and qualitative data, which will be analyzed to inform a future large-scale randomized clinical trial of the problem-solving intervention.
Tipo de estudio
Intervencionista
Inscripción (Actual)
83
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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Missouri
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Columbia, Missouri, Estados Unidos, 65212
- University of Missouri Ambulatory Palliative Care Clinic
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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
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 18 years of age or older,
- access to an Internet-connected device that will support videoconferencing software
Exclusion Criteria:
- Younger than 18 years of age,
- lack of access to an Internet-connected device that will support videoconferencing software
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 |
---|---|
Comparador activo: Unenhanced Monitoring
Family caregivers of cancer patients receiving outpatient palliative care will complete standardized questionnaires at the time of study enrollment and two, four, and eight weeks after study enrollment.
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Study participant completes standardized questionnaires upon study enrollment and at two, four, and eight weeks after study enrollment.
Otros nombres:
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Experimental: Problem-Solving Intervention
Family caregivers of cancer patients receiving outpatient palliative care will use videoconferencing tools to participate in three problem-solving sessions with a member of the research team.
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Study participant completes standardized questionnaires upon study enrollment and at two, four, and eight weeks after study enrollment.
Otros nombres:
The problem-solving approach that will be taught in the problem-solving intervention is based on the ADAPT model, which encourages participants to follow five steps when solving problems: focus on adopting a positive attitude to problem-solving, define the problem and set goals, generate a list of alternative solutions to the problem, predict consequences of the alternative solutions, and try implementing the most promising solution from among the list of alternatives.
The problem-solving intervention will be delivered by a trained interventionist in three structured sessions using videoconferencing tools.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in anxiety (as measured by the Generalized Anxiety Disorder Form - 7)
Periodo de tiempo: Upon study enrollment, two weeks, four weeks, eight weeks
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Family caregivers indicate the frequency with which they experience seven different symptoms of anxiety (7 items); higher scores reflect higher anxiety severity.
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Upon study enrollment, two weeks, four weeks, eight weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in depression (as measured by the Patient Health Questionnaire - 9)
Periodo de tiempo: Upon study enrollment, two weeks, four weeks, eight weeks
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Family caregivers indicate the frequency with which they experience nine different symptoms of depression (9 items); higher scores reflect higher depression severity.
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Upon study enrollment, two weeks, four weeks, eight weeks
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Change in problem-solving approach (as measured by the Problem-Solving Inventory)
Periodo de tiempo: Upon study enrollment, two weeks, four weeks, eight weeks
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Family caregivers indicate the extent to which different statements describing approaches to problem-solving apply to them (25 items).
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Upon study enrollment, two weeks, four weeks, eight weeks
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Change in quality of life (as measured by the Caregiver Quality of Life Index - Revised)
Periodo de tiempo: Upon study enrollment, two weeks, four weeks, eight weeks
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Family caregivers complete four items rating their physical, emotional, social, and financial quality of life on a scale of 0-10.
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Upon study enrollment, two weeks, four weeks, eight weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in caregiving problems and intensity
Periodo de tiempo: Upon study enrollment, two weeks, four weeks, eight weeks
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Family caregivers select three problems and rate their corresponding distress using a scale of 0-3 where 0 = problem is not at all distressful and 3 = problem is very distressful (3 items).
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Upon study enrollment, two weeks, four weeks, eight weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Karla Washington, PhD, University of Missouri-Columbia
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
- Washington KT, Benson JJ, Chakurian DE, Popejoy LL, Demiris G, Rolbiecki AJ, Oliver DP. Comfort Needs of Cancer Family Caregivers in Outpatient Palliative Care. J Hosp Palliat Nurs. 2021 Jun 1;23(3):221-228. doi: 10.1097/NJH.0000000000000744.
- Washington KT, Craig KW, Parker Oliver D, Ruggeri JS, Brunk SR, Goldstein AK, Demiris G. Family caregivers' perspectives on communication with cancer care providers. J Psychosoc Oncol. 2019 Nov-Dec;37(6):777-790. doi: 10.1080/07347332.2019.1624674. Epub 2019 Jun 16.
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 (Actual)
1 de abril de 2015
Finalización primaria (Actual)
29 de abril de 2017
Finalización del estudio (Actual)
24 de mayo de 2017
Fechas de registro del estudio
Enviado por primera vez
17 de abril de 2015
Primero enviado que cumplió con los criterios de control de calidad
27 de abril de 2015
Publicado por primera vez (Estimar)
28 de abril de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de octubre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
24 de octubre de 2021
Última verificación
1 de octubre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2002215
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. .
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