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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

OutcomeInstrumentBaselinePost-intervention3-month follow-up1-year follow-up
T0T1T2T3
Primary outcome
 Cardiorespiratory fitnessCardiopulmonary Exercise Test (CPET)XXX 
Secondary outcomes
 Functional performanceShort Physical Performance Battery (SPPB)XXX 
 Muscle StrengthLeg Press 1-RMXXX 
Hand grip strength (HGS)XXX 
 Physical activityActigraph GT3X+ accelerometerXXX 
 Body compositionAnthropometryXXX 
Mid arm and waist circumferenceXXX 
Bioimpedance analysisXXX 
 Dietary intakeDietary interviewXXX 
Foodbook24XXX 
 Nutrition-related symptomsGastrointestinal Symptom Rating Scale (GSRS)XXX 
Simplified Nutritional Appetite Questionnaire (SNAQ)XXX 
 Quality of LifeEORTC-QLQ-C30XXXX
 Cancer specific quality of LifeEORTC-QLQ-OG25 (oesophago-gastric cancer)XXXX
EORTC-QLQ-HCC18 (liver cancer)XXXX
EORTC-QLQ-PAN26 (pancreatic cancer)XXXX
 FatigueMultidimensional Fatigue Inventory (MFI-20)XXX 
 Qualitative approachSemi –structured interviews (focus groups or 1:1) XX 
 Cost analysesClinical salaries, overheads and equipment costs   X
 Blood samplesSerum, plasma and whole bloodXXX 
 AdherenceRecord in case report form/ exercise diary X  
 Other
  Sociodemographic detailsParticipant self-reportX   
  Medical/ Cancer historyMedical recordsX   
  Adverse eventsReports of patients/ research personnelXXXX