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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