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 [14,15,16] 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 | 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) | ✓ | |||