Aspects of Quality of Life During Adjuvant Oncological Treatment for Locally Advanced Lung Cancer Which Include Immune Checkpoint Inhibitor.
30 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Studietype
Observationeel
Inschrijving (Geschat)
75
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Sofie Jakobsson, Associated professor
- Telefoonnummer: +46766182858
- E-mail: sofie.jakobsson@fhs.gu.se
Studie Locaties
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Gothenburg, Zweden, 405 30
- Werving
- Department of Oncology, Sahlgrenska University Hospital
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Contact:
- Niklas Olofsson, PhD- student
- E-mail: niklas.olofsson@vgregion.se
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Contact:
- Sofie Jakobsson, Ass. professor
- E-mail: sofie.jakobsson@fhs.gu.se
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
Patients cared for at a specialized oncology centre in Västra Götaland, Sweden and at a regional hospital in Jönköping region in Sweden.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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.
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Changes in self-reported health during oncological treatment measured with EQ-VAS.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Changes in health promoting factors during oncological treatment assessed with SEMCD-4.
Tijdsspanne: 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.
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 september 2026
Primaire voltooiing (Geschat)
31 december 2028
Studie voltooiing (Geschat)
31 december 2029
Studieregistratiedata
Eerst ingediend
27 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
4 augustus 2026
Eerst geplaatst (Werkelijk)
10 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 september 2026
Laatste update ingediend die voldeed aan QC-criteria
30 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ImmLungCare- Quality of life
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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