- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01709344
Reducing Disability in Older Adult Cancer Survivors
A Phase I Randomized Controlled Trial of a Problem-solving Occupational Therapy Intervention for Older Adult Cancer Survivors
Older adults who are treated for cancer are at risk of developing disabilities due to the symptoms of cancer and the side effects of treatment. Disability occurs when a person has trouble performing the activities he or she needs to do in everyday life. For example, fatigue and pain can make it difficult for an older adult to do housework, leisure, or volunteer activities. Disability makes it harder for older adults to stay active and be productive members of the community, and it can increase the costs of healthcare.
Current approaches to cancer rehabilitation focus on using exercise, education, and social support to reduce cancer treatment side effects. These are important strategies to reduce disability, yet some side effects persist despite best efforts to resolve them. To fully reduce disability, people often need to adapt their activities or the environments in which they are performed.
The goal of this study is to test an occupational therapy (OT) intervention that teaches activity planning skills to foster survivors' ability to adapt activities, routines, and environments in order to minimize disability. The project targets adults over the age of 65 who are experiencing disability during or after cancer treatment. The project has two stages. First, twelve older adult cancer survivors will individually participate in the community-based intervention. After they have completed the program the investigators will revise the intervention to emphasize what they found most effective and helpful, and to eliminate aspects of the intervention that are perceived as unhelpful or redundant. The research question for this first stage of the project is, "To what degree is it feasible for survivors to enroll in the study, complete the six-week intervention, and complete the three outcome assessments?" In the second stage of the project, the investigators will test the revised intervention, comparing it to conventional care. The research question for the second stage of the project is, "Do the people receiving the intervention have higher activity levels, greater behavioral activation, lower levels of disability, and better quality of life compared to those people who receive traditional cancer care?" The intervention is appropriate for people who have been diagnosed with any type of cancer. It is designed to focus on whatever activities are most important to each participant. The novelty of the proposed intervention lies in the combination of the OT strategies of activity and environmental adaptation with explicit training in activity planning to teach survivors to find creative ways to engage in valued activities (e.g., taking care of one's home and family members, and participating in leisure, community, social and work activities). If the intervention is effective in reducing disability, it will give us another tool to reduce the impact of cancer on the daily lives of cancer survivors.
Visão geral do estudo
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth-Hitchcock Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria
- Age 65 years or older.
- Experiencing disability as indicated by a score of > 3 on the Vulnerable Elders Survey or an answer of "yes" to the question "Do health problems interfere with your ability to carry out your social or day to day activities?"
- Either: a. Diagnosed with any solid or hematological cancer, undergoing treatment for curative intent or within six months of completion of therapy with absence of disease recurrence; or b.Diagnosed with metastatic breast cancer or chronic hematologic malignancies with a life expectancy of > 2 years
Exclusion Criteria
- Moderate or worse cognitive impairment as indicated by a score of 3 or less on the Callahan six-item cognitive screening tool.
- Medical record documentation of severe mental illness (i.e., schizophrenia or bipolar disorder), active suicidal ideation, or active substance use disorder.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: PS-OT
Problem-solving Occupational Therapy
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Outros nomes:
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Outro: Usual care
Access to all supportive and rehabilitative services available at DHMC
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Supportive and rehabilitation services available at DHMC
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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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Disability
Prazo: Eight weeks
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Late-Life Function and Disability Instrument
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Eight weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Quality of Life
Prazo: Eight weeks
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Functional Assessment of Cancer Therapy
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Eight weeks
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Activity level
Prazo: Eight weeks
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Activity Card Sort
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Eight weeks
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Behavioral activation
Prazo: Eight weeks
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Behavioral activation scale
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Eight weeks
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Depression
Prazo: Eight weeks
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Patient Health Questionnaire-9 (PHQ-9)
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Eight weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
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
Outros números de identificação do estudo
- D12110
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 .
Ensaios clínicos em Câncer
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Turku University HospitalLounais-Suomen SyöpäyhdistysAinda não está recrutandoSobrevivente de cancerFinlândia
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)RetiradoSobrevivente de cancerEstados Unidos
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University of Alabama at BirminghamNational Cancer Institute (NCI); Auburn UniversityConcluído
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos
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Wake Forest University Health SciencesNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos, Guam
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Wake Forest University Health SciencesNational Cancer Institute (NCI); National Institute of Mental Health (NIMH)ConcluídoSobrevivente de cancerEstados Unidos
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Masonic Cancer Center, University of MinnesotaConcluídoSobrevivente de cancerEstados Unidos
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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
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Abramson Cancer Center of the University of PennsylvaniaConcluídoPlano de cuidados de sobrevivência LIVESTRONG: coleta contínua de dados e pesquisa de acompanhamentoPaciente com cancerEstados Unidos
Ensaios clínicos em PS-OT
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The University of Texas Medical Branch, GalvestonUniversity of Texas Southwestern Medical Center; United States Army Institute... e outros colaboradoresConcluídoFraqueza muscular | Músculo; fadiga, coração | Efeito Tardio da Queimadura | Reabilitação de queimadurasEstados Unidos
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Henry Ford Health SystemHenry Ford HospitalConcluídoImplante transcateter de válvula aórticaEstados Unidos
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Chang Gung Memorial HospitalConcluído
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Seoul National University Bundang HospitalAtivo, não recrutandoDerrame | HemiplegiaRepublica da Coréia
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Oncotartis, Inc.DesconhecidoLinfoma | Linfoma Folicular | Linfoma de Células B | Linfoma Não-Hodgkin | Linfoma de Células T | Linfoma de Hodgkin | Linfoma de Células T PeriféricasEstados Unidos
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Virginia Commonwealth UniversityConcluídoCoordenação ou Função Motora; Transtorno do DesenvolvimentoEstados Unidos
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Loma Linda UniversityConcluídoDepressão | Estresse, Psicológico | Ansiedade | Transtorno de Estresse Pós-TraumáticoEstados Unidos
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University of MichiganRetiradoFibrose por Radiação
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The Methodist Hospital Research InstituteAinda não está recrutando
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Johns Hopkins UniversityInscrevendo-se por conviteDorme | Depressão, ansiedade | Inatividade física | Internação PsiquiátricaEstados Unidos