Non-Small Cell Carcinoma of Lung
Conditions
Keywords
non-small lung cancer, quality of life, self-reported health, immunotherapy, oncological treatment
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.
Interventions
None listed
Sponsors
Göteborg University
Västra Götalandsregionen
Region Jönköping County
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in aspects of Quality of life (totalscore and subscale scores) during oncological treatment measured with the questionnaire EORTC QLQ C30. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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'). |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
Countries
Sweden
Contacts
CONTACTSofie Jakobsson, Associated professor
Outcome results
None listed