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Table 2 Follow-up schedule

From: SUPR-3D: A randomized phase iii trial comparing simple unplanned palliative radiotherapy versus 3d conformal radiotherapy for patients with bone metastases: study protocol

 

Pre-Treatment

Treatment

Follow-Up

Early Termination

Tests & Procedures

Recruitment

Enrollment/

Baseline

Day 1

Day 5

Week 2

Day 14

(+/− 3 days)

Week 4

Day 28

(+/−  3 days)

(collect only if patient allows/agrees)

Pre-Screen

X

      

Informed Consent

X

      

Eligibility Screen

 

X

     

aHistory and physical exam

 

X

     

aPregnancy Test (if applicable)

 

X

     

Patient Diary

(provided to patient)

  

X

X

Day 1–5

   

b Brief Pain Inventory

 

X

X

 

X

X

X

Functional Living Index - Emesis

 

X

X

 

X

X

X

PRO-CTCAE & QoL EORTC QLQ-C15-PAL

  

X

 

X

X

X

Treatment Related Data

  

X

    

HCP-reported baseline and follow up form (Medications and Toxicity)

 

X

  

X

X

X

  1. a may be done within 90 days, or 3 months, prior to enrollment
  2. b BPI on Day 1 does not need to be administered again if collection was done within 1 week of baseline