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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

  

Others

• 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