Aspects of Quality of Life During Adjuvant Oncological Treatment for Locally Advanced Lung Cancer Which Include Immune Checkpoint Inhibitor.
30 sierpnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Warunki
Typ studiów
Obserwacyjny
Zapisy (Szacowany)
75
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Sofie Jakobsson, Associated professor
- Numer telefonu: +46766182858
- E-mail: sofie.jakobsson@fhs.gu.se
Lokalizacje studiów
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Gothenburg, Szwecja, 405 30
- Rekrutacyjny
- Department of Oncology, Sahlgrenska University Hospital
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Kontakt:
- Niklas Olofsson, PhD- student
- E-mail: niklas.olofsson@vgregion.se
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Kontakt:
- Sofie Jakobsson, Ass. professor
- E-mail: sofie.jakobsson@fhs.gu.se
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Metoda próbkowania
Próbka prawdopodobieństwa
Badana populacja
Patients cared for at a specialized oncology centre in Västra Götaland, Sweden and at a regional hospital in Jönköping region in Sweden.
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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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.
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Changes in self-reported health during oncological treatment measured with EQ-VAS.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Changes in health promoting factors during oncological treatment assessed with SEMCD-4.
Ramy czasowe: 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.
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 września 2026
Zakończenie podstawowe (Szacowany)
31 grudnia 2028
Ukończenie studiów (Szacowany)
31 grudnia 2029
Daty rejestracji na studia
Pierwszy przesłany
27 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
4 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
10 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
2 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
30 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ImmLungCare- Quality of life
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .