Table 4.

Instruments, underlying concepts, and timing

Concept	Measured byb	Timinga
		T0 (Before randomization)	T1 (T0 + 12 weeks)	T2 (T0 + 24 weeks)
Outcome measures used for the primary endpoints
Emotional Functioning	EORTC [14–16] 10 emotional functioning items described by Jabbarian et al. [15]. For patients (10 items): For caregivers (10 items):	✓	✓	✓
Self-efficacy	The Lewis´ Cancer self-efficacy scale [17] (validated by Northouse [5]) For patients (17 items) For caregivers (17 items)	✓	✓	✓
Outcome measures used for the secondary endpoints
Quality of life (also covers additional secondary outcomes such as hopelessness, anxiety, depression, etc.)	For patients (23 items): - EORTC QLQ-C15-PAL [18] plustwo social functioning items (#26, 27) + one item about overall health (#29) from EORTC QLQ-C30 [19] - Social well-being scale from FACT-G [20] For caregivers (35 items): - The Caregiver Quality of Life Index-Cancer (CQOLC) [21]	✓	✓	✓
Benefits of illness	Benefits of illness scale [22] For patients (5 items) For caregivers (5 items)	✓	✓	✓
Coping	A shortened version of Brief Cope [23] (#1–3,5-10,13-16,19-21,23–26) For patients (20 items) For caregivers (20 items)	✓	✓	✓
Dyad communication	The five items ‘Active engagement scale’ from the ´Ways of giving support questionnaire´ [24]. Three scales (10 items) from the ‘Dyadic Coping Inventory’ [25]: ‘Stress communication by oneself’, ‘Stress communication by partner’ and ‘Evaluation of dyadic coping’. For patients (15 items) For caregivers (15 items)	✓	✓	✓
Health economic measures	EQ5D5L [26] and CSRI [27] For patients (23 items) For caregivers (14 items)	✓	✓	✓
Background characteristics
Socio demographics, illness-related factors, social factors	A mix of socio-demographic items from different studies (self-constructed): - Sex, age, relationship status, living situation, having children, educational level, employment status, total monthly net income, financial difficulties related to physical condition or medical treatment, private medical insurance, religion, member of a minority ethnic group, dyad’s relationship For patients (14 items) For caregivers (15 items)	✓
Other aspects evaluated
Items about computer skills	Three FOCUS items about computer skills (self-constructed) For patients (2 items) For caregivers (2 items)	✓
Process evaluation	FOCUS items asking about experience and satisfaction with the intervention. (self-constructed) For patients (12 items) For caregivers (12 items)		✓
Process evaluation	Experiences with the intervention: (self-constructed) - Interviews with patients and family caregivers - Interviews with nurses delivering the intervention		✓
	Fidelity: FOCUS+ (self-constructed) Session characteristics (e.g. length, timing), random sample intervention checklists, random sample audio-taped intervention sessions		✓
	Fidelity: iFOCUS (self-constructed) Data from web-based program (e.g. number of sessions logged into, time taken to complete session)		✓
	Routine data on recruitment (self-constructed) (e.g. potential participants, initial engagement, eligible participants, enrolment)	✓

^aFor T₁, questionnaires can be filled in between T₀ + 12 weeks minimum and T₀ + 16 weeks maximum. For T₂, questionnaires can be filled in between T₀ + 24 weeks minimum and T₀ + 28 weeks maximum

^bAll measures were validated in each of the participating countries