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Table 3 Study procedure

From: PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial

 

Inclusion

Intervention implementation

6 months intervention

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t-1

T0

T1

T2

T3

T4

T5

T6

T7

Exposed (E) or Non-exposed (NE) patients

E

NE

E

NE

E

NE

E

NE

E

NE

E

NE

E

NE

E

NE

E

NE

Enrollment:

              

 Initial oncologist consult (geriatric frailties screening G8 scale)

X

X

                

 Comprehensive Geriatric Assessment (CGA) (social isolation evaluation, eligibility screening)

X

X

                

 Informed consent

X

X

                

 Allocation

X

X

                

 Social worker initial evaluation (SE)

  

SE

SE

              

 Domotic pack installation

  

X

X

              

Intervention:

 Oncologist consult and treatment

  

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 Social worker telephone follow-up (TF)

    

TF

 

TF

 

TF

 

TF

 

TF

 

TF

   

 Domotic and remote assistance care package

    

X

 

X

 

X

 

X

 

X

 

X

   

Assessments:

 Autonomy (ADL + IADL); Nutritional and functional status evaluation

X

X

      

X

X

    

X

X

  

 Tumor response (RECIST 1.1)

        

X

X

    

X

X

X

X

 Dose response-intensity (Bonadonna criteria)

        

X

X

    

X

X

  

 Treatment toxicity (NCI-CTCAE)

    

X

X

X

X

X

X

X

X

X

X

X

X

  

 QoL evaluation (EORTC QLQ-C30 + ELD 14 module)

  

X

X

    

X

X

    

X

X

  

 Survival

                

X

X

  1. t -1 inclusion; T0 intervention implementation (15 days or less after t–1, T1 1 month after T0 +/– 1 week, T2 1 month after T1 +/– 1 week, T3 1 month after T2 +/– 1 week, T4 1 month after T3 +/– 1 week, T5 1 month after T4 +/– 1 week, T6 1 month after T5 +/– 1 week, T7 12 months after T1)
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Trials

ISSN: 1745-6215