Aspects of Quality of Life During Adjuvant Oncological Treatment for Locally Advanced Lung Cancer Which Include Immune Checkpoint Inhibitor.

August 30, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients cared for at a specialized oncology centre in Västra Götaland, Sweden and at a regional hospital in Jönköping region in Sweden.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in aspects of Quality of life (totalscore and subscale scores) during oncological treatment measured with the questionnaire EORTC QLQ C30.
Time Frame: From enrollment before oncological treatment up til 18 months after start of treatment
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.
From enrollment before oncological treatment up til 18 months after start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in self-reported health during oncological treatment measured with EQ-VAS.
Time Frame: From enrollment before oncological treatment up til 18 months after start of treatment
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').
From enrollment before oncological treatment up til 18 months after start of treatment
Changes in Quality of life specifically in patients with lung cancer during oncological treatment measured with the questionnaire EORTC QLQ - LC13.
Time Frame: From enrollment before oncological treatment up til 18 months after start of treatment
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.
From enrollment before oncological treatment up til 18 months after start of treatment
Changes in well-being related to immune checkpoint modulators during oncological treatment measured with the questionnaire FACT-ICM.
Time Frame: From enrollment before oncological treatment up til 18 months after start of treatment
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.
From enrollment before oncological treatment up til 18 months after start of treatment
Changes in existensial health during oncological treatment measured with the questionnaire FACIT-Sp-12.
Time Frame: From enrollment before oncological treatment up til 18 months after start of treatment
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.
From enrollment before oncological treatment up til 18 months after start of treatment
Changes in health promoting factors during oncological treatment assessed with SOC-13.
Time Frame: From enrollment before oncological treatment up til 18 months after start of treatment
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.
From enrollment before oncological treatment up til 18 months after start of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in health promoting factors during oncological treatment assessed with SEMCD-4.
Time Frame: From enrollment before oncological treatment up til 18 months after start of treatment
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.
From enrollment before oncological treatment up til 18 months after start of treatment
Perceived quality of care during onocological treatment measued with GPCCQ 1.0 Scale.
Time Frame: From enrollment before oncological treatment up til 18 months after start of treatment
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.
From enrollment before oncological treatment up til 18 months after start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

Region Jönköping County
Västra Götalandsregionen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

July 27, 2026

First Submitted That Met QC Criteria

August 4, 2026

First Posted (Actual)

August 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 30, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ImmLungCare- Quality of life

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe