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. 2020 Nov 4;10(11):e036854. doi: 10.1136/bmjopen-2020-036854

Table 3.

Summary of outcome measurements

Outcome Instrument T0 T1 T2
Primary outcomes
Body composition CT imaging for the assessment of skeletal muscle area X X
Bioelectric impedance analysis for the assessment of fat mass X X X
Physical fatigue Multidimensional Fatigue Inventory64 X X X
Physical function European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 3063 X X X
Secondary outcomes
Physical activity Accelerometer (actigraph) for objective measurement of physical activity in 7 consecutive days during all waking hours X X X
Physical Activity Scale for the Elderly78 for self-reported levels of physical activity X X X
Physical fitness Maximum oxygen uptake (peak VO2) during a maximum exercise test on a cycle ergometer using a ramp protocol for the assessment of cardiorespiratory fitness X X X
Handheld dynamometer for the assessment of muscle strength X X X
Body mass index Body height on a calibrated scale to the nearest 0.1 mm X X X
Body weight on a calibrated scale to the nearest 0.1 kg X X X
Dietary intake; WCRF/AICR guidelines Food frequency questionnaire (developed by Wageningen University) X X X
Dietary intake; protein intake Self-composed food frequency questionnaire X X X
Health-related quality of life and symptoms European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Ovarian Cancer Module 2879 X X X
European Organisation for Research and Treatment of Cancer Quality of Life questionnaire–Chemotherapy-Induced Peripheral Neuropathy 20-Item Scale80 X X X
Hospital Anxiety and Depression Scale81 X X X
Pittsburgh Sleep Quality Index82 X X X
Chemotherapy therapy completion rates and treatment toxicity Medical records of which chemotherapy completion rates will be assessed as the relative dose intensity, that is, the amount of particular chemotherapy given in relation to the originally planned chemotherapy dose X
Other study parameters
Blood sampling Venous blood sample (40 mL) X X
Smoking and sociodemographics Self-composed questionnaire X
Contamination of control group* Self-composed questionnaire X

*Parameter will only be assessed in the control group.

AICR, American Institute for Cancer Research; WCRF, World Cancer Research Fund.