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

NCT07754409 | Not Yet Recruiting

• 1 other identifier: ImmLungCare- Quality of life
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-Small Cell Carcinoma of Lung

Keywords

non-small lung cancer; quality of life; self-reported health; immunotherapy; oncological treatment

Outcome Measures

Primary Outcomes (1)

• Changes in aspects of Quality of life (totalscore and subscale scores) during oncological treatment measured with the questionnaire EORTC QLQ C30.

  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 Outcomes (5)

• Changes in self-reported health during oncological treatment measured with EQ-VAS.

  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.

  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.

  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.

  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.

  From enrollment before oncological treatment up til 18 months after start of treatment

Other Outcomes (2)

• Changes in health promoting factors during oncological treatment assessed with SEMCD-4.

  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.

  From enrollment before oncological treatment up til 18 months after start of treatment

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead
• Västra Götalandsregionen: collaborator
• Region Jönköping County: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Sofie Jakobsson, Associated professor

CONTACT

+46766182858; sofie.jakobsson@fhs.gu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 10, 2026

Record last verified: 2026-08