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Table 1 Summary of data/biological sample collection

From: Impact of a one-year supervised physical activity program on long-term cancer-related fatigue and mediating effects of the gut microbiota in metastatic testicular cancer patients: protocol of the prospective multicentre, randomized controlled phase-III STARTER trial

Evaluation

Time points

Inclusion (D0)

End CT (M3)

M6

M12

Y2

Y3

Y4

Y5

Y6

Y7

Y8

Y9

Y10

 

Clinical Examination

Pain

X

X

X

X

X

X

        

Tumour Evaluation

 

X

X

X

X

X

X

X

X

X

X

X

X

 

Cardiovascular toxicities

   

X

X

X

X

X

X

X

X

X

X

 

Second primary tumour

   

X

X

X

X

X

X

X

X

X

X

 

Questionnaires

CRF (QLQ-FA12)

X

X

X

X

X

X

X

X

X

X

X

X

X

 

HRQoL (QLQ-C30/TC26)

X

X

X

X

X

X

X

X

X

X

X

X

X

 

Cognition (FACT-Cog)

X

X

 

X

X

X

        

Anxiety/depression (HADS)

X

X

X

X

X

X

        

PA/sedentary levels (ONAPS-PAQ)

X

X

X

X

X

X

X

X

X

X

X

X

X

 

Pain and neuropathies (VAS)

X

X

X

X

X

X

        

Nutrition (WCRF)

X

X

X

X

X

X

        

Sustainable return to work

   

X

X

X

        

Motivation (EMAPS)

X

X

 

X

          

Satisfaction with the connected activity tracker

   

X

          

Satisfaction with the intervention

   

X

          

Practice locations

X

             

Physical condition/fitness

6-min walk test

X

X

X

X

X

X

        

Sit-to-stand test

X

X

X

X

X

X

        

Handgrip test

X

X

X

X

X

X

        

Anthropometrics

X

X

X

X

X

X

        

Number of steps per day (connected activity tracker)

Every day, non-stop (up to M12)

          

Heart rate (connected activity tracker)

Non-stop (up to M12)

          

Sleep quality (connected activity tracker)

Non-stop (up to M12)

          

Gut microbiota study

Blood sampling

X

X

 

X

 

X

        

Optional faecal sampling

X

X

 

X

 

X

        

Blood biomarkers

Gut microbial metabolites

X

X

 

X

 

X

        

Inflammation/Immunity

X

X

 

X

 

X

        

Liver function

X

X

 

X

 

X

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