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NCT Number: NCT07754409

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

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.

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Key information

Conditions

Non-Small Cell Carcinoma of Lung Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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').

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sofie Jakobsson, Associated professor

CONTACT

[email protected]

+46766182858

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Region Jönköping County
  • Västra Götalandsregionen

Registry information

Official study title

Self-reported Health During Adjuvant Immunotherapy for Locally Advanced Lung Cancer - the ImmLungCare Project.

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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