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Table 1 Flow of study procedures

From: Behavioral and psychological impact of returning breast density results to Latinas: study protocol for a randomized clinical trial

 

Study period

 

Enrollment

Allocation

Post-allocation

Timepoint

-T1

0

T1

T2

T3

T4

Enrolment:

 Eligibility screen

X

     

 Informed consent

X

     

 Allocation

 

X

    

Interventions:

 Enhanced (letter + brochure)

  

X

   

 Interpersonal (letter + brochure + promotora)

  

X

   

Assessmentsa:

 Age, ethnicity, language preference (EHR)

X

X

    

 Mammogram results, clinical characteristics (EHR)

  

X

   

 Demographics and personal/family health history

  

X

   

 STAI and related psychological measures

  

X

X

X

 

 PROMIS short form depression

  

X

X

X

 

 MDB knowledge

  

X

X

X

 

 Acceptability of MBD results information delivery

   

X

  

 Self-reported knowledge of MBD results

   

X

  

 Intention to adhere to mammography screening

   

X

X

 

 Discussions with healthcare provider

   

X

X

 

 Information seeking about MBD

    

X

 

 Self-reported mammography adherence

    

X

 

 Mammography adherence and follow up (EHR)

    

X

X

  1. EHR electronic health record, STAI State-Trait Anxiety Inventory, PROMIS Patient-Reported Outcomes Measurement Information System, MBD mammographic breast density
  2. aAssessments are self-report surveys unless noted as EHR (chart abstraction)