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Table 3 Schedule for data collection during the EMINENT trial

From: Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in breast cancer post-treatment follow-up: a study protocol for a phase II randomised controlled trial (the EMINENT trial)

 

Study period

Enrolment

Allocation

Post-allocation

Close-out

Timepoint

-t1

0

t1

t2

t3

t4

tx

Enrolment

 Eligibility screen

X

      

 Informed consent

X

      

 Allocation

 

X

     

Interventions

 EMINENT

       

 Usual Care

       

Primary endpoints

 Health-related quality of life

  

X

X

X

X

 

Secondary endpoint

 Patient experience of care

  

X

    

 Dietary behaviours

  

X

X

X

X

 

 Physical activity and sedentary behaviours

  

X

X

X

X

 

 Financial toxicity

  

X

 

X

X

 

 Adherence to clinical assessments

      

X

 Health resource utilisation

   

X

X

X

X

 Satisfaction of care

     

X

 

 Acceptance of intervention

     

X

 

Participant characteristics

 Demographics

  

X

    

 Clinical characteristics

  

X

    

Process outcomes

 Completion of intervention component

     

X

 

 Clinical encounters at cancer centre

      

X

 Referrals back to acute care

      

X

 GP and specialist visits

      

X

  1. t1 baseline, t2 3 months, t3 6 months, t4 12 months