- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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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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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Under and over 65 years
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Key measures that will be the focus of the study is Quality of life.
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The total burden of symptoms will be one key measures in this observational study.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 59081001
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