Skip to main content

Table 1 Pre-EMpT data collection

From: Prostate cancer–Exercise and Metformin Trial (Pre-EMpT): study protocol for a feasibility factorial randomized controlled trial in men with localised or locally advanced prostate cancer

  

Study period

 

Pre-trial

Allocation

Post-allocation

   

RC1

 

RC2

 

RC3

 

Timepoint

 

0

~ 3 weeks

~ 9 weeksa

3 months

~ 14 weeksb

6 months

12 months

Enrolment:

 Eligibility screen

x

       

 Randomisation consent

 

x

      

 Informed consent

  

x

     

 Interview consent

      

x

 

Assessments:

 Demographic data

  

x

 

x

 

x

x

 Family medical history

  

x

 

x

 

x

x

 Height (cm)

  

x

     

 Weight (kg)

  

x

 

x

 

x

 

 Blood sample

  

x

 

(x)

 

x

 

 Leisure time physical activity [28]

  

x

 

x

 

x

x

 Urinary symptoms [29]

  

x

x

x

 

x

x

 Psychological factors [30, 31]

  

x

 

x

 

x

x

 Patient function and bother [32]

  

x

 

x

 

x

x

 Health beliefs [adapted from [33, 34]

  

x

 

x

 

x

x

 Quality of life measures [35]

  

x

 

x

 

x

x

 Cancer-related fatigue [36, 37]

  

x

 

x

x

x

x

 Lifestyle behaviours (drinking and smoking)

  

x

 

x

 

x

x

 Prostate tissue

  

[x]

     

 Step count (pedometer)

  

x

 

x

 

x

x

 Physical activity intensity/step count (Garmin)

  

x

 

x

 

x

 

 Metformin tablet count

  

x

 

x

 

x

 

 Qualitative interview

      

x

 
  1. RC research clinic, [x] = collected during surgery 1-week post-baseline; (x) = metformin groups only
  2. aSurgical participants only
  3. bRadiotherapy participants only