- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01399541
Recovery and Rehabilitation After Lung Cancer Surgery
The specific aims of this translational, interdisciplinary, multi-center, international research study with 300 Lung cancer patients are to:
Aim 1 Explore how the patients experience the transfer between different locations and between different levels of care at the same location and how they experienced coming home.
Aim 2 Explore lung cancer patients' symptoms, symptom clusters, and changes in symptoms and symptom clusters over time.
Aim 3 Explore interaction between lung cancers patients' symptoms, symptom clusters, health related quality of life and social support.
Visão geral do estudo
Status
Condições
Descrição detalhada
Approximately 2500 patients are diagnosed with lung cancer annually i Norway, and approximately 400 of these undergo surgery. Many patients report that life after lung cancer surgery is difficult. After surgery, the patients are frequently transferred to a local hospital or to another level of care at the hospital where they were operated. The transfer is critical for patients' safety because communication failure is one of the most common causes of medical error.
Studies that have analyzed the quality of life of lung cancer patients after surgery reach different conclusions about the patients' Quality of life (QOL), some studies state that lung cancer patients are back to normal quality of life after 9 months, while others indicate that the patients still have reduced QOL two years after surgery. It is difficult to assess the reason for the differences in results as most of the studies used the same QOL questionnaire. Studies that have evaluated the social support that lung cancer patients receive indicate that lung cancer patients receive less support than other cancer patients.
Lung cancer patients have a wide range of physical problems (fatigue, dyspnea, coughing and pain) and psychological (depression) problems following surgery.
Based on findings from this literature review a need exist for improved postoperative follow-up of patients after surgery for lung cancer The proposed study will evaluate the social support, the levels of lung cancer stigma, symptoms and changes in this over time as well as evaluate patient experience with transfer in the immediate postoperative period.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Bergen, Noruega, 5021
- Haukeland Sykehus
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Oslo, Noruega, 0407
- Ullevaal University Hospital
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Oslo, Noruega, 0037
- Rikshospitalet, OUS
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Trondheim, Noruega, 7006
- St. Olavs Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- patients with lung cancer patients above the age of 18 that have been treated with surgery, who are able to speak and understand Norwegian,
Exclusion Criteria:
- and who suffer no cognitive impairment.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Under and over 65 years
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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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Key measures that will be the focus of the study is Quality of life.
Prazo: 1 year with 5 measurement points
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Data will be collecetd using the self administered questionnaire: EORTC QLQ-C30 + LC13
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1 year with 5 measurement points
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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The total burden of symptoms will be one key measures in this observational study.
Prazo: one year with 5 measuresments
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The self administered questionnaire: Memorial Assessment scale (MSAS) Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
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one year with 5 measuresments
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A key measure to measure fatigue will be used.
Prazo: one year with five measurements points
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The self administered questionnaire: Lee Fatigue Scale, LFS.
Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
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one year with five measurements points
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A key measures to measure sleep disturbances will be used.
Prazo: One year with five measurements points
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A questionnaire: General sleep disturbances scale (GSDS).
Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
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One year with five measurements points
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A key measures will be used to evaluate social support
Prazo: One year with two measurements points
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The self administered questionnaire: Social Provision Scale.
Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
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One year with two measurements points
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A self administered questionnaire to measure Anxiety
Prazo: One year with five measurements points
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The self administered questionnaire: State and trait anxiety (STAI).
Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
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One year with five measurements points
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A self administered questionnaire to measure pain
Prazo: one year with five measurements points
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The self administered questionnaire: Brief Pain Inventory.
Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
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one year with five measurements points
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Depression is a key measure
Prazo: One year with five measurements points
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The self administered questionnaire: Self-report depression scale (CES-D).
Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
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One year with five measurements points
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One key measures that will be used to evaluate stigma related to having lung cancer in this observational study.
Prazo: 1 year with one measurements points
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Data will be collected using the self administered questionnaire: Cataldo Lung Cancer Stigma Scale (CLCSS)
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1 year with one measurements points
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tone Rustøen, PhD, Oslo University Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
- 59081001
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