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Recovery and Rehabilitation After Lung Cancer Surgery

5 de agosto de 2018 actualizado 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.

Descripción general del estudio

Estado

Terminado

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

De observación

Inscripción (Actual)

300

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

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.

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Under and over 65 years

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Key measures that will be the focus of the study is Quality of life.
Periodo de tiempo: 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 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
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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de octubre de 2010

Finalización primaria (Actual)

1 de abril de 2014

Finalización del estudio (Actual)

1 de abril de 2018

Fechas de registro del estudio

Enviado por primera vez

1 de octubre de 2010

Primero enviado que cumplió con los criterios de control de calidad

20 de julio de 2011

Publicado por primera vez (Estimar)

21 de julio de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de agosto de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

5 de agosto de 2018

Última verificación

1 de agosto de 2018

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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