A Videogame Intervention for Children With Cancer

NCT05796895 | Unknown

• 1 other identifier: 2022-6833-21251
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer

Keywords

Childhood cancer; Videogame; Health-related Quality of Life; Mixed Methods; Low and Middle-Income Country

Outcome Measures

Primary Outcomes (2)

• 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).

  Children of both groups will be administered the Pediatric Quality of Life Inventory Generic Core Scale (PedsQL 4.0) at baseline and at eight weeks to assess the change in the Health-related Quality of Life (HRQOL). The responses on individual items are recorded on a 5-point Likert scale (0 = never a problem to 4 = almost always a problem), and the scores are converted from 0 to 100. The higher the score, the more favorable is the HrQOL.

  Baseline, pre-intervention and eight weeks post-intervention

• 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).

  Children of both groups will be administered the Pediatric Quality of Life Inventory Cancer Module (PedsQL 3.0) at baseline and at eight weeks to assess the change in the Health-related Quality of Life (HRQOL).The responses on individual items are recorded on a 5-point Likert scale (0 = never a problem to 4 = almost always a problem), and the scores are converted from 0 to 100. The higher the score, the more favorable is the HrQOL.

  Baseline, pre-intervention and eight weeks post-intervention

Secondary Outcomes (1)

• 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).

  Baseline, pre-intervention and eight weeks post-intervention

Other Outcomes (5)

• Patient-reported Acceptability and Satisfaction of the videogame intervention on the Acceptability E-scale.

  Eight weeks post-intervention

• Patient-reported Appropriateness of the videogame intervention assessed in qualitative interviews from the intervention group child-parent dyads.

  Eight weeks post-intervention

• Cost of development of the videogame intervention as determined from the videogame development team.

  Baseline, pre-intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Children will be provided with the videogame through which we will teach them symptom management strategies.

Behavioral: Videogame

Attention Control Group

ACTIVE COMPARATOR

An attention control group will be used in this study for comparison with the intervention group. Children of the attention control group will receive weekly WhatsApp messages on general health behaviours.

Behavioral: WhatsApp

Interventions

Videogame BEHAVIORAL

Children will be provided with the videogame for eight weeks, through which they will be taught symptom management strategies. Children and their parents will be telephoned every week by a nurse to inquire whether children performed the strategies taught to them and if they have any health concerns. Children and parents can also call the nurse educator if they have any questions. Their queries/concerns will be responded to by the nurse educator in consultation with the clinical health experts (doctors and nurses) in the research team.

Intervention Group

WhatsApp BEHAVIORAL

Children will be provided with weekly WhatsApp messages on healthy behaviors. Children and their parents will be telephoned every week by a nurse to inquire whether they have any health concerns. Children and parents can also call the nurse educator if they have any questions. Their queries/concerns will be responded to by the nurse educator in consultation with the clinical health experts (doctors and nurses) in the research team.

Attention Control Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

Related Publications (1)

• Sajjad S, Gul RB, Sayani S, Fadoo Z, Abbasi AN, Barolia R. Development and testing of a videogame intervention for symptom management among 8-18 years old children with cancer: a study protocol. BMJ Paediatr Open. 2024 Oct 16;8(1):e002679. doi: 10.1136/bmjpo-2024-002679.

  PMID: 39414341 DERIVED

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Sehrish Sajjad, MScN

CONTACT

+92 21 34865429; sehrish.sajjad@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: April 4, 2023
• Study Start: May 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share