Aspects of Quality of Life During Adjuvant Oncological Treatment for Locally Advanced Lung Cancer Which Include Immune Checkpoint Inhibitor.
30 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Type d'étude
Observationnel
Inscription (Estimé)
75
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Sofie Jakobsson, Associated professor
- Numéro de téléphone: +46766182858
- E-mail: sofie.jakobsson@fhs.gu.se
Lieux d'étude
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Gothenburg, Suède, 405 30
- Recrutement
- 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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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Patients cared for at a specialized oncology centre in Västra Götaland, Sweden and at a regional hospital in Jönköping region in Sweden.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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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.
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in self-reported health during oncological treatment measured with EQ-VAS.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
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Changes in health promoting factors during oncological treatment assessed with SEMCD-4.
Délai: 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.
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
31 décembre 2028
Achèvement de l'étude (Estimé)
31 décembre 2029
Dates d'inscription aux études
Première soumission
27 juillet 2026
Première soumission répondant aux critères de contrôle qualité
4 août 2026
Première publication (Réel)
10 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ImmLungCare- Quality of life
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .