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. 2024 Oct 16;8(1):e002679. doi: 10.1136/bmjpo-2024-002679

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
  • It comprises 23 items and has 4 dimensions (physical, emotional, social and school functioning)

  • Have a 5-point Likert response scale (0=never to 4=almost always a problem).

  • A higher score=better HRQOL.

  • Adequate construct and predictive validity and reliability values of >0.8 have been reported in multiple studies.

  • The scales specific for 8–12 and 13–18 years old children will be used in this study.

Preintervention,and8 weeks post intervention
Pediatric Quality of Life Inventory Cancer Module (PedsQL 3.0).37
  • It comprises 27 items and has 8 domains about cancer symptoms.

  • Have a 5-point Likert scale (0=never to 4=almost always a problem).

  • A higher score=better HRQOL.

  • Sufficient construct validity and reliability values of >0.8 in all domains have been reported in multiple studies.

  • The scales specific for 8–12 and 13–18 years old children will be used in this study.

Preintervention, and8 weeks post intervention
Secondary outcome—cancer symptoms frequency and distress Memorial Symptom Assessment Scale Short Form (MSAS-SF).38
  • It comprises 32 items and has a 5-point Likert Scale (0=not at all to 4=very much).

  • A higher score=more distress and higher frequency.

  • Sufficient convergent and criterion validity measures and internal consistency reliability values ranging from 0.76 to 0.87 have been reported in earlier studies.

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:
  • Participant recruitment.

  • Participant refusals.

  • Lost to follow-up participants, with reasons.

Fidelity Data on children’s progress in the videogame will be retrieved from the dashboard. The following data will be reported:
  • Total game score

  • Number and reason for contacting the RA by children in both groups

HRQOLhealth-related quality of lifeRAresearch associate