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Recovery and Rehabilitation After Lung Cancer Surgery

5 de agosto de 2018 atualizado por: Tone Rustøen, Oslo University Hospital

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

Concluído

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

Observacional

Inscrição (Real)

300

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Bergen, Noruega, 5021
        • Haukeland Sykehus
      • Oslo, Noruega, 0407
        • Ullevaal University Hospital
      • Oslo, Noruega, 0037
        • Rikshospitalet, OUS
      • Trondheim, Noruega, 7006
        • St. Olavs Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

Eligible patients are lung cancer patients above the age of 18 that have been treated with surgery, who are able to speak and understand Norwegian, and who suffer no cognitive impairment. The patients in the study must give written informed consent to participation in the study. It is estimated that we need 300 patients.

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

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Under and over 65 years

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Key measures that will be the focus of the study is Quality of life.
Prazo: 1 year with 5 measurement points
Data will be collecetd using the self administered questionnaire: EORTC QLQ-C30 + LC13
1 year with 5 measurement points

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
The total burden of symptoms will be one key measures in this observational study.
Prazo: one year with 5 measuresments
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.
one year with 5 measuresments
A key measure to measure fatigue will be used.
Prazo: one year with five measurements points
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.
one year with five measurements points
A key measures to measure sleep disturbances will be used.
Prazo: One year with five measurements points
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.
One year with five measurements points
A key measures will be used to evaluate social support
Prazo: One year with two measurements points
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.
One year with two measurements points
A self administered questionnaire to measure Anxiety
Prazo: One year with five measurements points
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.
One year with five measurements points
A self administered questionnaire to measure pain
Prazo: one year with five measurements points
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.
one year with five measurements points
Depression is a key measure
Prazo: One year with five measurements points
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.
One year with five measurements points
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
Data will be collected using the self administered questionnaire: Cataldo Lung Cancer Stigma Scale (CLCSS)
1 year with one measurements points

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Tone Rustøen, PhD, Oslo University Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de outubro de 2010

Conclusão Primária (Real)

1 de abril de 2014

Conclusão do estudo (Real)

1 de abril de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

1 de outubro de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de julho de 2011

Primeira postagem (Estimativa)

21 de julho de 2011

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de agosto de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de agosto de 2018

Última verificação

1 de agosto de 2018

Mais Informações

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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