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Table 3 ReStOre II study outcomes

From: Rehabilitation strategies following oesophagogastric and Hepatopancreaticobiliary cancer (ReStOre II): a protocol for a randomized controlled trial

Outcome Instrument Baseline Post-intervention 3-month follow-up 1-year follow-up
T0 T1 T2 T3
Primary outcome
 Cardiorespiratory fitness Cardiopulmonary Exercise Test (CPET) X X X  
Secondary outcomes
 Functional performance Short Physical Performance Battery (SPPB) X X X  
 Muscle Strength Leg Press 1-RM X X X  
Hand grip strength (HGS) X X X  
 Physical activity Actigraph GT3X+ accelerometer X X X  
 Body composition Anthropometry X X X  
Mid arm and waist circumference X X X  
Bioimpedance analysis X X X  
 Dietary intake Dietary interview X X X  
Foodbook24 X X X  
 Nutrition-related symptoms Gastrointestinal Symptom Rating Scale (GSRS) X X X  
Simplified Nutritional Appetite Questionnaire (SNAQ) X X X  
 Quality of Life EORTC-QLQ-C30 X X X X
 Cancer specific quality of Life EORTC-QLQ-OG25 (oesophago-gastric cancer) X X X X
EORTC-QLQ-HCC18 (liver cancer) X X X X
EORTC-QLQ-PAN26 (pancreatic cancer) X X X X
 Fatigue Multidimensional Fatigue Inventory (MFI-20) X X X  
 Qualitative approach Semi –structured interviews (focus groups or 1:1)   X X  
 Cost analyses Clinical salaries, overheads and equipment costs     X
 Blood samples Serum, plasma and whole blood X X X  
 Adherence Record in case report form/ exercise diary   X   
 Other
  Sociodemographic details Participant self-report X    
  Medical/ Cancer history Medical records X    
  Adverse events Reports of patients/ research personnel X X X X