- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02112461
Hospice and End-of-life Symptom Monitoring & Support Using an Automated System Designed for Family Caregivers (SCP)
Enhancing End-of-Life and Bereavement Outcomes Among Cancer Caregivers: Symptom Care by Phone for Hospice Caregiver Support and Cancer Symptom Relief
Visão geral do estudo
Descrição detalhada
Individuals dying from cancer often live out their lives at home with a host of poorly controlled symptoms. Ineffective symptom management results, in part, from inadequate monitoring of patients once they leave the treatment-focused arena of the clinical setting. The changing pattern of symptoms is challenging as care strategies and recommendations from previous encounters with healthcare providers become quickly outdated. The burden of end-of-life care largely falls to family caregivers, usually a spouse or partner, who feel enormous pressure to provide physical and supportive care but often lacks the knowledge and skill resulting in significant caregiver burden and distress that may extend into bereavement.
This prospective, clinical trial proposes to develop and test a telecommunication system, Symptom Care by Phone- Hospice that has been designed to bridge the divide between home and palliative care support for patients at the end of life and their family caregiver. SCP-Hospice has three elements: 1) daily monitoring of symptoms common at end of life, 2) automated alerting of the hospice nurse case manager about symptoms that have exceeded a pre-set threshold for symptom severity or caregiver distress about symptoms, and 3) automated, just in time, tailored care management strategies for the caregiver to implement to address the patient's symptoms. Caregivers call the SCP-Hospice system daily to report patient symptoms and then are immediately provided automated, tailored care suggestions paired to the specific symptom profile.
The specific aims of the study are to test whether the SCP-Hospice intervention reduces severity and distress from 12 different symptoms and whether it decreases caregiver burden, anxiety, depressed mood and distress about the patient's symptoms and improves caregiver sleep when compared with usual care. The mechanisms that explain how SCP-Hospice affect these outcomes also will be explored. Other aims will compare patient care strategies utilized by caregivers and evaluate caregiver and Hospice nurse satisfaction with the SCP system.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- University of Utah College of Nursing
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Patient/Caregiver Dyad Inclusion Criteria:
- Both patient and caregiver are adults age 18 or over
- Patients has a limited life expectancy and has histological diagnosis of cancer
- Caregiver is caring for a family member with a limited life expectancy and admitted to one of the participating home care hospice or palliative care programs
- Caregiver is English speaking and writing
- Caregiver has access to a telephone on a daily basis
- Caregiver is cognitively and physically able to use the phone unassisted and complete questionnaires.
- Patient is assigned to a nurse case manager who has consented to participate in the research project
- Caregiver and patient intend to reside in the local area until the time of the patient's death
Exclusion Criteria:
- patient not being cared for by a partnering hospice
- patient without a histological diagnosis of cancer
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Intervention Group
SCP-Hospice Alert
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The intervention in Project 1 SCP utilizes a multi-faceted system.
The SCP-Hospice symptom management model will include several features: 1) a computer-based telecommunication system to monitor symptoms as perceived and reported by the family caregiver; 2) tailored care management messages that SCP provides directly to the caregivers to promote care management based on the individualized patient symptom profile and caregiver distress; and 3) an automated alerting function that notifies the hospice nurse of unrelieved symptoms that have exceeded a pre-set threshold.
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Sem intervenção: Usual Care
Caregiver calls into monitoring system to report the patient's end of life symptoms but does not receive feedback about the symptoms and the hospice nurse does not receive the information.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Family Caregiver's Assessment of Dying Patient's Symptom Severity Level at End-of-Life
Prazo: Changes in patient's end-of-life symptom levels are reported daily by the family caregiver from baseline (date of consent) until the patient's death or 6 months whichever occurs last.
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Caregiver's report their assessment of the severity of patient's symptoms daily.
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Changes in patient's end-of-life symptom levels are reported daily by the family caregiver from baseline (date of consent) until the patient's death or 6 months whichever occurs last.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kathleen H Mooney, PhD, University of Utah
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 33122-SCP
- 1P01CA138317 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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University of New MexicoNew Mexico State University; University of New Mexico Cancer CenterConcluído
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Ohio State University Comprehensive Cancer CenterConcluídoSobrevivente de cancerEstados Unidos
Ensaios clínicos em SCP-Hospice Alert
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The University of Texas at ArlingtonNational Institute on Aging (NIA)Concluído
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The University of Texas Medical Branch, GalvestonAtivo, não recrutandoProlapso de órgãos pélvicosEstados Unidos
-
Lonneke van de Poll-FranseComprehensive Cancer Centre The Netherlands; Dutch Cancer SocietyConcluídoCancro do ovário | Câncer de endométrioHolanda
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Zuyderland Medisch CentrumAbbVieAtivo, não recrutandoDoença de ParkinsonHolanda
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Centre Hospitalier Universitaire de NiceConcluídoCondição não reconhecida
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University of PennsylvaniaNational Cancer Institute (NCI); American Cancer Society, Inc.ConcluídoFibrose | Câncer de Cabeça e Pescoço | LinfedemaEstados Unidos
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Allium, Ltd.ConcluídoProlapso de órgãos pélvicos
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Datascope Patient MonitoringConcluídoEvento CardíacoEstados Unidos
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Stanford UniversityConcluído
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University Health Network, TorontoMcGill University Health Centre/Research Institute of the McGill University... e outros colaboradoresConcluído