Table 1.
Overview of the assessment schedule
| Measures | Planned assessment time points | Drop- out | ||||
| Baseline (T0–month 0) |
During treatment | End of treatment (T1–month 4) |
3-month follow-up (T2–month 7) |
6-month follow-up (T3–month 10) |
||
| Primary outcome | ||||||
| Distress | ||||||
| HADS | x | x | x | x | x | |
| Secondary outcomes | ||||||
| Self-efficacy | ||||||
| GSES | x | x | x | x | x | |
| Quality of Life | ||||||
|
EORTC-QLQ-C30 EQ-5D-5L |
x x |
x x |
x x |
x x |
x x |
|
| Mindfulness | ||||||
| FMI | x | x | x | x | x | |
| Distress | ||||||
|
DT HADS |
x x |
x x |
x x |
x x |
x x |
x x |
| Depression and anxiety | ||||||
| PHQ-4 | x | x | x | x | x | x |
| Internet-related variables | x | |||||
| Resource use | x | x | x | |||
| Client satisfaction, usability and predictors of usage | ||||||
| CSQ-I | x | x | ||||
| SUS | x | x | ||||
| UTAUT | x | |||||
| ETHSA | x | x | ||||
| Usage behaviour* | x | |||||
| Self-generated items† | x | x | x | x | x | x |
| Demographic and medical characteristics‡ | x | |||||
*Usage behaviour refers to both groups. For the experimental group, it implies: time per day, type and number of modules started, type and number of modules finished, time since last log in, frequency of log in, frequency of each module, time for each module, % of each module completed, type and number of videos and audios started and type and number of videos and audios finished. For the control group, it implies: time per day, type and number of ‘modules’ displayed, time since last log in, frequency of log in, frequency of each ‘module’, time for each ‘module’, whereby a ‘module’ is defined as brief written psychoeducational information.
†Self-generated items on acceptability, satisfaction with the Make It Training, mindfulness, self-efficacy, coping and skills as well as eHealth-related variables (eg, internet experience).
‡Changes in the medical conditions and social demographic parameters of the patients will be continually assessed.
CSQ-I, Client Satisfaction Questionnaire adapted to Internet-based interventions; DT, Distress Thermometer; EORTC-QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; EQ-5D-5L, European Quality of Life 5 Dimensions 5 Level Version; ETHSA, Evaluation Tool for Healthcare Smartphone Applications; FMI, Freiburg Mindfulness Inventory; GSES, General Self-Efficacy; HADS, Hospital Anxiety and Depression Scale; PHQ-4, Patient Health Questionnaire-4; SUS, System Usability Scale; UTAUT, unified theory of acceptance and use of technology model.