- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Bergen, Norsko, 5021
- Haukeland Sykehus
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Oslo, Norsko, 0407
- Ullevaal University Hospital
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Oslo, Norsko, 0037
- Rikshospitalet, OUS
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Trondheim, Norsko, 7006
- St. Olavs Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Under and over 65 years
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Key measures that will be the focus of the study is Quality of life.
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
The total burden of symptoms will be one key measures in this observational study.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Tone Rustøen, PhD, Oslo University Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 59081001
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