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Table 1 Schedule of enrollment, interventions, and assessments

From: Evaluating a couple-based intervention addressing sexual concerns for breast cancer survivors: study protocol for a randomized controlled trial

 

Enrollment

Allocation

Post-allocation

Eligibility

T0

Baseline

T1

Sessions

1–4

Post-Session

T2

3 Months

T3

6 Months

T4

ENROLLMENT

 Eligibility screen

X

     

 Informed consent

 

X

    

 Allocation

 

X

    

INTERVENTIONS

 IE intervention

  

X

   

 LHT intervention

  

X

   

MEASURES

Primary outcome

 Female Sexual Function Index

  (FSFI)a

 

X

 

X

X

X

Secondary outcomes

 Male partners: International Index of Erectile Function (IIEF)

 Female partners: FSFI

 

X

 

X

X

X

 Female Sexual Distress Scale-

Revised (FSDS-R)a

 

X

 

X

X

X

 Miller Social Intimacy Scale (MSIS)

 

X

 

X

X

X

 Dyadic Adjustment Scale-7 item

(DAS-7)

 

X

 

X

X

X

 Patient Health Questionnaire-9 item (PHQ-9)

 

X

 

X

X

X

 Generalized Anxiety Disorder 7-item (GAD-7)

 

X

 

X

X

X

Mediators

 Dyadic Sexual Communication Scale (DSCS)a

 

X

 

X

  

 Self-efficacy (for coping with sexual concerns)a

 

X

 

X

  
  1. aA patient-only measure