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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 Close-out
  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)