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

Table 2 Outcome definitions

Domain	Measure	Metric	Method of aggregation	Time points (for comparison)
	Primary outcome
Sexual function	Female Sexual Function Index (FSFI)^a	Difference in change scores	Mean score	T1–T2; T1–T3; T1–T4
	Secondary outcomes
Sexual function	Male partners: International Index of Erectile Function (IIEF) Female partners: FSFI	Difference in change scores; difference in proportions	Mean score; proportions by clinical cut-off score	T1–T2; T1–T3; T1–T4
Sexual distress	Female Sexual Distress Scale- Revised (FSDS-R)^a	Difference in change scores	Mean score	T1–T2; T1–T3; T1–T4
Relationship intimacy	Miller Social Intimacy Scale (MSIS)	Difference in change scores	Mean score	T1–T2; T1–T3; T1–T4
Relationship quality	Dyadic Adjustment Scale-7 item (DAS-7)	Difference in change scores	Mean score	T1–T2; T1–T3; T1–T4
Psychological distress	Patient Health Questionnaire-9 item (PHQ-9)	Difference in change scores	Mean score	T1–T2; T1–T3; T1–T4
Psychological distress	Generalized Anxiety Disorder 7-item (GAD-7)	Difference in change scores	Mean score	T1–T2; T1–T3; T1–T4

ISSN: 1745-6215