TrueNTH sexual recovery study protocol: a multi-institutional collaborative approach to developing and testing a web-based intervention for couples coping with the side-effects of prostate cancer treatment in a randomized controlled trial

Table 2 Study measures and data collection timeline

Variable	Measure	Assessment
		Baseline		3 Months		6 Months
		Patient	Partner	Patient	Partner	Patient	Partner
PRE-EXISTING AND CLINICAL CHARACTERISTICS
Demographics	Demographic survey	X	X			X	X
Comorbidities	Katz Comorbidity Questionnaire Charlson Comorbidities Index	X	X			X	X
Clinical data	Medical Chart Review	X		X		X
Patient prostate cancer related symptoms	Expanded Prostate Cancer Index Composite (EPIC)	X		X		X
Patient expectation of sexual function	Expanded Prostate Cancer Index Composite-Exp (EPIC-Exp)	X
Partner sexual function
Female	Female Sexual Function Index (FSFI)		X		X		X
Male	The International Index of Erectile Function (IIEF)		X		X		X
Expectations	Expectation of Success of Treatment	X	X
PRIMARY OUTCOME
Global Satisfaction with Sex Life	Patient Reported Outcome Measure Information System (PROMIS) Global Sexual Satisfaction	X	X			X	X
SECONDARY OUTCOMES
Interest in sex	PROMIS Interest in Sex Life	X	X	X	X	X	X
Sexual activity	PROMIS Sexual Activity	X	X	X	X	X	X
Resources
Use of Aids	PROMIS Use of Aids	X	X	X	X	X	X
Knowledge	Knowledge Building Assessment	X	X	X	X
Dyadic Coping	Dyadic Coping Inventory (DCI)	X	X			X	X
Grief	Prolonged Grief about the Loss of Sexual Function			X	X	X	X
Quality of Life	Quality of Life EQ-5D	X	X	X	X	X	X
Satisfaction with Intervention	Satisfaction with Intervention					X	X

ISSN: 1471-2407