Aspects of Quality of Life During Adjuvant Oncological Treatment for Locally Advanced Lung Cancer Which Include Immune Checkpoint Inhibitor.
30 de agosto de 2026 actualizado por: Sofie Jakobsson, Göteborg University
Self-reported Health During Adjuvant Immunotherapy for Locally Advanced Lung Cancer - the ImmLungCare Project.
Current oncological treatment for patients with locally advanced lung cancer comprise adjuvant immunotherapy (immune checkpoint inhibitors-ICI) as an additional one-year treatment after chemoradiotherapy which increases overall survival and progression-free survival.
Patients with lung cancer have a high burden of distressful symptoms at diagnosis and during chemoradiotherapy.
Side-effects from immunotherapy differs, they are unspecific and may develop at any point during treatment.
However, it is not investigated thoroughly during adjuvant treatment in locally advanced lung cancer.
As new oncological treatments are being introduced, focus must be placed on patients quality of life and how patients endure treatment to be able to know how to best support patients during this treatment.
The knowledge gained from this project include how adjuvant immunotherapy treatment impacts health.
This knowledge is sparse due to the novelty of the treatment.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
De observación
Inscripción (Estimado)
75
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.
Estudio Contacto
- Nombre: Sofie Jakobsson, Associated professor
- Número de teléfono: +46766182858
- Correo electrónico: sofie.jakobsson@fhs.gu.se
Ubicaciones de estudio
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Gothenburg, Suecia, 405 30
- Reclutamiento
- Department of Oncology, Sahlgrenska University Hospital
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Contacto:
- Niklas Olofsson, PhD- student
- Correo electrónico: niklas.olofsson@vgregion.se
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Contacto:
- Sofie Jakobsson, Ass. professor
- Correo electrónico: sofie.jakobsson@fhs.gu.se
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra de probabilidad
Población de estudio
Patients cared for at a specialized oncology centre in Västra Götaland, Sweden and at a regional hospital in Jönköping region in Sweden.
Descripción
Inclusion Criteria:
- Patients with locally advanced non-small lung cancer
- cared for at either one of two specialized oncology centres
- ≥ 18 years of age
- planned for concurrent chemoradiotherapy including ICI for 12 months
- performance status 0-2.
Exclusion Criteria:
- diseases or comorbidities that may have significant impact on the outcome variables
- limited understanding of the Swedish language preventing the possibility to give oral and written informed consent.
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 |
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Patients with locally advanced lung cancer cared for at two specialized oncology centres.
Inclusion criteria: locally advanced lung cancer, ≥ 18 years of age, planned for concurrent chemoradiotherapy including ICI for 12 months and performance status 0-2.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Changes in aspects of Quality of life (totalscore and subscale scores) during oncological treatment measured with the questionnaire EORTC QLQ C30.
Periodo de tiempo: From enrollment before oncological treatment up til 18 months after start of treatment
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Changes between baseline and 12 months after start of immunotherapy will be assessed with the European Organisation for Research and Treatment of Cancer Quality of life scale (EORTC QLQ-C30).
The 30 item instrument measure quality of life in patients with cancer.
Scores range from 0-100 where a higher score represents higher quality of life.
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From enrollment before oncological treatment up til 18 months after start of treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in self-reported health during oncological treatment measured with EQ-VAS.
Periodo de tiempo: From enrollment before oncological treatment up til 18 months after start of treatment
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Changes in general health will be assessed with EQ-VAS which is a visual analogue scale, measuring a persons overall health-related quality of life.
The scale ranges from 100 (the best health you can imagine) to 0 (the worst health you can imagine').
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From enrollment before oncological treatment up til 18 months after start of treatment
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Changes in Quality of life specifically in patients with lung cancer during oncological treatment measured with the questionnaire EORTC QLQ - LC13.
Periodo de tiempo: From enrollment before oncological treatment up til 18 months after start of treatment
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A lung cancer module to assess quality of life when having a lung cancer.
The European Organisation for Research and Treatment of Cancer Quality of life in lung cancer scale EORTC QLQ - LC13 comprise 13 items, scores range from 0-100 where a higher score represents better quality of life.
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From enrollment before oncological treatment up til 18 months after start of treatment
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Changes in well-being related to immune checkpoint modulators during oncological treatment measured with the questionnaire FACT-ICM.
Periodo de tiempo: From enrollment before oncological treatment up til 18 months after start of treatment
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Functional Assessment of Cancer Therapy - Immune Checkpoint Modulator (FACT ICM) comprise 52 items (5 point Likert-type response alternatives between 0 not at all -4 very much).
Higher scores indicates better well-being.
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From enrollment before oncological treatment up til 18 months after start of treatment
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Changes in existensial health during oncological treatment measured with the questionnaire FACIT-Sp-12.
Periodo de tiempo: From enrollment before oncological treatment up til 18 months after start of treatment
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Functional Assessment of Chronic Illness Therapy -Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) measures perceived existensial health with a 5 point Likert-type scale (0 not at all - 4 very much), higher score indicates better perceived existensial health.
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From enrollment before oncological treatment up til 18 months after start of treatment
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Changes in health promoting factors during oncological treatment assessed with SOC-13.
Periodo de tiempo: From enrollment before oncological treatment up til 18 months after start of treatment
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Sense of coherence scale (SOC-13) is a 13- item scale comprised of three components: Comprehensibility, Manageability and Meaningfulness.It aims to measure how persons cope with stressfull situations as for example cancer.
Scores 13-91 where higher scores indicate better coping strategies.
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From enrollment before oncological treatment up til 18 months after start of treatment
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Changes in health promoting factors during oncological treatment assessed with SEMCD-4.
Periodo de tiempo: From enrollment before oncological treatment up til 18 months after start of treatment
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A person's self-efficacy asessed with Self-Efficacy to Manage Chronic Disease (SEMCD) Scale.
With the SEMCD the patient rate confidence related to four tasks on a 1 to 10 scale (1 not at all confident" and 10 totally confident).
A higher score indicates better self-efficay.
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From enrollment before oncological treatment up til 18 months after start of treatment
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Perceived quality of care during onocological treatment measued with GPCCQ 1.0 Scale.
Periodo de tiempo: From enrollment before oncological treatment up til 18 months after start of treatment
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The Generic Person-centred Care Questionnaire (GPCCQ) assess patients experiences of Personcentredness in Care.
Totally 18 items assess perceived personcentredness on a likert scale from 1 not at all to 5 completely.
A higher score indicates higher personcentredness.
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From enrollment before oncological treatment up til 18 months after start of treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
31 de diciembre de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2029
Fechas de registro del estudio
Enviado por primera vez
27 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de agosto de 2026
Publicado por primera vez (Actual)
10 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
30 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ImmLungCare- Quality of life
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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