Skip to main content

Table 2 Schedule of enrollment, interventions, and assessments

From: Opening the Conversation: study protocol for a Phase III trial to evaluate a couple-based intervention to reduce reproductive and sexual distress among young adult breast and gynecologic cancer survivor couples

 

Enrollment eligibility

T0

Allocation baseline

T1

Post-allocation

  

Sessions 1–4

Sessions 1–5

T2 2 weeks

T3 3 months

ENROLLMENT

 Eligibility screen

X

     

 Informed consent

X

     

 Allocation

 

X

    

INTERVENTIONS

 OC intervention

   

X

  

 SS intervention

  

X

   

ASSESSMENTS

Primary outcomes

Reproductive distress

 Fertility Problem Inventory (FPI)-Relationship Concern Domain

 

X

  

X

X

Sexual distress

 Sexual and Relationship Distress Scale (SaRDS)

 

X

  

X

X

Secondary outcomes

Relationship functioning

 Dyadic Adjustment Scale (DAS-7)

 

X

  

X

X

Relationship intimacy

 Miller Social Intimacy Scale (MSIS)

 

X

  

X

X

Communication about reproductive concerns

 Couples’ Illness Communication Scale (CSIS)

 

X

  

X

X

Communication about sexual concerns

 Couples’ Illness Communication Scale (CSIS)

 

X

  

X

X

Sexual function (female)

 Female Sexual Function Index (FSFI)

 

X

  

X

X

Sexual function (male)

 International Index of Erectile Function (IIEF)

 

X

  

X

X

Sexual satisfaction

 General Measure of Sexual Satisfaction (GMSEX)

 

X

  

X

X

Depressive symptoms

 Patient Health Questionnaire Depression Scale (PHQ-8)

 

X

  

X

X

Health-related quality of life

 PROMIS Global 10 v1.2

 

X

  

X

X

Self-efficacya

 Self-Efficacy to Communicate about Sex and Intimacy (SECSI)

 

X

  

X

X

Mediating variables

 Dyadic coping

Dyadic Coping Inventory (DCI)

X

  

X

X

 Communication quality

Communication Patterns Questionnaire- Short Form (CPQ-SF)

X

  

X

X

  1. aCancer survivor-only measure