Outcomes | Instrument | t0 | t1 | t2 | t3 | t4 | t5 | t6 |
---|---|---|---|---|---|---|---|---|
Primary endpoint | ||||||||
Overall 2-year survival | Medical log (ongoing assessment) | |||||||
Secondary endpoints | ||||||||
2-year non-relapse mortality, median (disease-free) survival | Medical log (ongoing assessment) | |||||||
Quality of life | EORTC QLQ30 / HDC-29 module | X | X | X | X | X | X | X |
Fatigue | Multidimensional Fatigue Inventory (MFI) | X | X | X | X | X | X | X |
Muscle strength | Isometric and isokinetic strength of representative muscle groups for upper and lower extremity measured at the IsoMed2000® | X | X | X | X | |||
Hand-Held-Dynamometer (isometric) | X | X | X | X | X | X | X | |
Cardiorespiratory fitness | CPET (VO2peak) | X | X | X | X | |||
6-min Walk Test | X | X | X | X | X | X | X | |
Body composition | bioelectrical impedance analysis, weight, height | X | X | X | X | X | X | X |
Physical Activity | Accelerometry | X | X | X | X | X | X | |
Depression | CES-D | X | X | X | X | X | X | X |
Distress | NCCN-Distress | X | X | X | X | X | X | X |
Locus of control | KKG (German) | X | X | X | X | X | X | X |
Cognitive function | Trail-making-test | X | X | X | X | X | X | X |
Common side-effects | VAS, every week, later every 3 weeks | |||||||
Biomarker | Various methods (ELISA) | X | X | X | X | X | X | X |
Oxidative stress marker | Analysed in urine samples | X | X | X | X | X | X | X |
Others | ||||||||
Socio-demographic factors | Recording of date of birth, education, occupation, familial situation, smoking, alcohol consumption | X | X | X | ||||
Medical history | Recording of pre-existing diseases, therapies | X | ||||||
Treatment data | Conditioning, complications | X | ||||||
Karnofsky Performance Score | Physician rating | X | X | X | X | X | X | X |
Medication (immunosuppression, corticosteroids, analgesics) | Recorded at each visit/phone call on a medication log form | X | X | X | X | X | X | X |
Physical activity history | Physical activity in adolescence, pre-diagnosis, during, and after intervention is recorded, including walking, cycling, and sports activities | X | X | X | X |