Clinical trial NCT05796895: A Videogame Intervention for Children With Cancer
Official title: Development and Testing of a Videogame Intervention for Improving the Health-related Quality of Life (HrQOL) of Children With Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: Childhood cancer
Videogame
Health-related Quality of Life
Mixed Methods
Low and Middle-Income Country
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 70
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two groups in parallel. The first will be the intervention group in which children will be provided with the videogame intervention for eight weeks. Children will play the videogame and learn about symptom management strategies through the game tasks. The children will complete the tasks, score points, and progress to the next game. The videogame will be connected to a web-based portal through which the research team will retrieve data regarding the progress of the children's gameplay.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators aim to improve the quality of life and well-being of children with cancer in low- and middle-income countries through a videogame intervention. In this study, first, the investigators will identify common symptoms faced by children with cancer during their cancer treatment and their parents. Based on what they share, the investigators will develop a videogame to teach children how to manage their symptoms at home. The investigators will provide the videogame intervention to a group of children with cancer, and the other group will receive general Whatsapp messages to improve their overall health. Through survey questions, the investigators will test the videogame intervention from the first group of children to see whether their symptom distress decreased and their quality of life improved. The investigators will also test the videogame intervention for its usefulness, through interviews from children, their parents, and healthcare providers.

Detailed description: The prevalence of childhood malignancies has been rising worldwide. Chemotherapy and radiation cause severe side effects harming children's health-related quality of life (HRQOL) and causing symptom distress. Children who actively participate in their self-care make healthier choices for themselves. Several studies suggest that children engage better with digital health interventions (DHIs) and learn self-care quickly, consequently improving their health outcomes. Videogames are an example of evolving DHI to engage children and educate them about symptom management.

An exploratory sequential mixed methods design will be employed. In the first phase, the investigators conducted in-depth interviews with child-parent dyads to explore their experiences with cancer treatment and their preferences regarding the videogame's design. In the study's second phase, the investigators will work with clinical and digital health professionals to design the videogame based on the interview results. The investigators will conduct a Randomized Controlled Pilot and Feasibility Study (Pilot-RCT) in the third phase. The investigators will provide the intervention group's children access to a gaming application to teach children how to take care of themselves and manage symptoms associated with cancer treatment. Weekly WhatsApp messages on healthy behaviours will be sent to children in the attention control group.

Eligibility criteria: Inclusion Criteria:

* 8-18 years old
* Diagnosed with any type and stage of cancer within six months of the diagnosis.
* Receiving active treatment
* Can comprehend Urdu and/or English language
* Have access to an android smartphone/tablet for at least 30 minutes/day to play the video game (either they or their parents own a smartphone)
* Provide informed assent and their parents provide written permission/consent.

Exclusion Criteria:

* Severely or critically ill
* Admitted only for blood transfusion without a diagnosis of cancer
* Receiving palliative treatment.
* Have presence of any diagnosed sight, hearing, cognitive impairment, or upper limb deformity limiting them to play the videogame.
* If already playing any videogame having the same content

Primary outcomes:
measure: Determine change in the Health-related Quality of Life (HRQOL) between study groups, from baseline at eight weeks, on the Pediatric Quality of Life Inventory Generic Core Scale (PedsQL 4.0).
timeFrame: Baseline, pre-intervention and eight weeks post-intervention
measure: Determine change in the Health-related Quality of Life (HRQOL) between study groups, from baseline at eight weeks, on the Pediatric Quality of Life Inventory Cancer Module (PedsQL 3.0).
timeFrame: Baseline, pre-intervention and eight weeks post-intervention
Secondary outcomes:
measure: Determine change in the Cancer Symptoms Frequency and Distress between study groups, from baseline at eight weeks, on the Memorial Symptom Assessment Scale Short Form (MSAS-SF).
timeFrame: Baseline, pre-intervention and eight weeks post-intervention
Other outcomes:
measure: Patient-reported Acceptability and Satisfaction of the videogame intervention on the Acceptability E-scale.
timeFrame: Eight weeks post-intervention
measure: Patient-reported Appropriateness of the videogame intervention assessed in qualitative interviews from the intervention group child-parent dyads.
timeFrame: Eight weeks post-intervention
measure: Cost of development of the videogame intervention as determined from the videogame development team.
timeFrame: Baseline, pre-intervention
measure: Proportions of children recruited, refused to participate, and loss to follow-up along with their reasons of refusal to participate and loss to follow-up.
timeFrame: Eight weeks post-intervention
measure: Total game score obtained by the participants in the videogame.
timeFrame: Eight weeks post-intervention
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