Outcomes | Instrument | T0 | T1 | T2 | T3 | T4 |
---|---|---|---|---|---|---|
Primary endpoints | ||||||
• Physical well being | Functional Assessment for Cancer Therapy – Lung | x | x | x | x | x |
• General fatigue | Multidimensional Fatigue Inventory | x | x | x | x | x |
Secondary endpoints | ||||||
• Physical performance (muscle strength and endurance capacity) | Spirometry, Six-Minute Walk Test, hand-held dynamometry, exercise log | x | x | x | x | x |
• Psychosocial parameters (depression, anxiety, demoralization) | Ultra-Brief Patient Health Questionnaire (PHQ-4), Demoralization Scale, locus of control, Mini Nutrition Assessment | x | x | x | x | x |
• Immunological parameters (cellular immunity, cytokine and chemokine panels in T-lymphocyte subsets) | Quantification of immune cell populations and tumor antigen reactive effector (memory T cells), detection of tumor reactive regulatory T cells, quantification of key immune effector molecules in serum. | x | x | x |  |  |
Others | ||||||
• Care management phone calls | Edmonton Symptom Assessment Scale | weekly |