Outcomes | Instrument | T0 | T1 | T2 | T3 | T4 | T5 |
---|---|---|---|---|---|---|---|
Primary endpoint | Â | Â | Â | Â | Â | Â | Â |
Fatigue | Fatigue assessment questionnaire (FAQ) | X | X | X | X | X | X |
Secondary endpoints | Â | Â | Â | Â | Â | Â | Â |
Quality of life | EORTC QLQ30 / BR-23 questionnaire | X | X | X | X | X | X |
Depression | Center for Epidemiological Studies Depression Scale (CES-D) | X | X | X | X | X | X |
Cognitive function | Trail-making-test | X | X | X | Â | X | X |
Body composition | Bioimpedance analysis, weight, height, waist and hip circumference | X | X | X | Â | 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 |
Cardio-respiratory fitness | Spiroergometry (VO2peak) | X | Â | X | Â | X | X |
Flexibility | Range of motion measured at the IsoMed2000® | X |  | X |  | X | X |
Radiotoxicity | Acute radiation dermatitis, LENT-SOMA classification for late effects, ECOG performance status, hemoglobin , and thrombocytes at end of radiotherapy | Â | X | X | Â | Â | Â |
Circulating immune cells | Analyzed in peripheral blood | X | X | X | Â | Â | Â |
Biomarkers of inflammation and oxidative stress | Analyzed in peripheral blood and urine | X | X | X | Â | Â | Â |
Salivary cortisol | Saliva collected at five different time points during a day | X | X | X | Â | Â | Â |
Sample collection data | Date and time of collection, as well as time since last food or fluid intake, vigorous physical activity (during last 12Â h), NSAID intake (during last 12Â h), smoking (during last 24Â h), caffeine intake (during last 6Â h), alcohol intake (last 48Â h), acute infections, and sleep quality during last night are recorded. | X | X | X | Â | Â | Â |
Safety of training interventions | Number of participants with lymphedema, pain, nausea, dyspnea, or tachycardia during the intervention phase | at each training session | |||||
Others | Â | Â | Â | Â | Â | Â | Â |
Socio-demographic factors | Recording of date of birth, education, occupation, socio-familial situation, smoking, alcohol consumption | X | Â | Â | Â | Â | Â |
Breast cancer characteristics | Family history, TNM status, grading, ER/PR status, HER2-score, p53, bcl-2, Ki-67, | X | Â | Â | Â | Â | Â |
Medical history | Recording of pre-existing diseases and of allergies | X | Â | Â | Â | Â | Â |
Treatment data | Pre-treatment: ECOG at diagnosis, date and type of breast surgery, affected lymph nodes, (neo-) adjuvant chemotherapy (type, last infusion), hormone therapy | Â | X | Â | Â | Â | Â |
Radiation: technique (3D, IMRT), type and dose, start and stop date, interruptions | |||||||
Concomitant medication | Recorded at each visit on a medication log form | X | X | X | Â | Â | Â |
Physical activity history | Physical activity in adolescence, pre-diagnosis, during, and after intervention is recorded, including walking, cycling, and sports | X | Â | X | X | X | X |