Evaluating a couple communication skills training (CCST) intervention for advanced cancer: study protocol for a randomized controlled trial

Table 1 Schedule of enrollment, interventions, and assessments

	Enrollment	Allocation	Post-allocation
	Eligibility	Baseline	Sessions	Mid-treatment	End of treatment	3 months
	T0	T1	1-6	T2 ^a	T3 ^b	T4 ^c
Enrollment
Eligibility screen	X
Informed consent		X
Allocation		X
Interventions
CCST Intervention			X
Education Intervention			X
Measures
Primary outcomes
Miller Social Intimacy Scale (MSIS)		X		X	X	X
Couple Satisfaction Index-8 (CSI-8)		X		X	X	X
Secondary outcomes
Hospital Anxiety and Depression Scale (HADS)		X		X	X	X
Positive and Negative Affective Scale (PANAS)		X		X	X	X
Life Completion subscale of the Quality of Life at the End of Life (QUAL-E)		X		X	X	X
Physical Well-being subscale of the Functional Assessment of Cancer Therapy (FACT)^d		X		X	X	X
Physical Symptom subscale of the Condensed Memorial Symptom Assessment Scale (CMSAS)^d		X		X	X	X
Patient health care use, advance care planning discussions, and advance directives^d		X		X	X	X
Treatment satisfaction					X
Mediators
Self-reported communication (Protective Buffering Scale, PBS)		X		X	X	X
Couple conversations coded for objective indices of communication: Linguistic Inquiry and Word Count (LIWC), Asymmetric Behavior Coding System (ABCS), Relational Affective Topography System (RATS)		X			X

ISSN: 1745-6215