Table 2. Study outcomes, tools and data ascertainment time points.
Outcome | Instrument|description | Data collection timepoint |
Clinical efficacy outcomes | ||
Primary outcome—HRQOL | Pediatric Quality of Life Inventory Generic Core Scale (PedsQL 4.0).37
|
Preintervention,and8 weeks post intervention |
Pediatric Quality of Life Inventory Cancer Module (PedsQL 3.0).37
|
Preintervention, and8 weeks post intervention | |
Secondary outcome—cancer symptoms frequency and distress | Memorial Symptom Assessment Scale Short Form (MSAS-SF).38
|
Preintervention and8 weeks post intervention |
Feasibility outcomes | ||
Acceptability and appropriateness | Acceptability E-scale39 will be used to determine the acceptability and appropriateness of the intervention in the study population. | Eight weeks postintervention |
In-depth interviews will be conducted with 7–8 child–parent dyads of the intervention group to obtain insights into their experiences regarding the intervention (appropriateness, satisfaction, learning, challenges and recommendations). | ||
One focus group discussion (FGD) will be conducted with 5–6 oncologists and nurses to identify the challenges in implementing the intervention in the clinical setting. | ||
Cost | The cost of the intervention development will be reported in Pakistani rupees. | |
Feasibility | The number and proportions will be reported for:
|
|
Fidelity | Data on children’s progress in the videogame will be retrieved from the dashboard. The following data will be reported:
|
HRQOLhealth-related quality of lifeRAresearch associate