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Table 2 Diagnostic outcomes. Assessments and instruments used in the POSITIVE study (Part III)

From: POSITIVE study: physical exercise program in non-operable lung cancer patients undergoing palliative treatment

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   
• Care management phone calls Edmonton Symptom Assessment Scale weekly
  1. Abbreviations: T0: Baseline; T1: 12 weeks after randomization; T2: 24 weeks after randomization; T3: 1st follow-up at week 40 after randomization; T4: 2nd follow-up at week 52 after randomization