Protocol

Development and testing of a videogame intervention for symptom management among 8–18 years old children with cancer: a study protocol

Abstract

Introduction Evidence shows that cancer treatment-related symptoms could be managed effectively in 8–18 years old children through Digital Health Interventions (DHIs), consequently improving their health-related quality of life (HRQOL). However, limited research is available about digitally mediated educative health interventions for children with cancer from lower-middle income countries like Pakistan. This study aims to develop a videogame intervention for children with cancer and test the clinical efficacy of the videogame concerning HRQOL and cancer treatment-related symptoms. Moreover, the following feasibility outcomes will be recorded: acceptability, appropriateness, cost, feasibility and intervention fidelity.

Methods and analysis An exploratory sequential mixed methods design is used in this study. In the first phase of the study, we interviewed 28 participants (14 child–parent dyads) and assessed their symptom experiences affecting children’s HRQOL. Moreover, their preferences for the development of the videogame were also elicited. Based on the findings from relevant literature and the interviews, we developed the videogame in collaboration with clinical and digital experts in the study’s second phase. In the third phase of the study, a pilot randomised controlled trial will be conducted at a Tertiary Care Hospital in Karachi, Pakistan. There will be two groups: the intervention group and the control group. The intervention group children will receive the videogame application for 8 weeks, during which symptom management strategies will be taught to them. Children in the attention control group will receive weekly WhatsApp messages on healthy behaviours.

The primary outcome will be the HRQOL of children, and the secondary outcome will be cancer symptoms frequency and distress. These outcomes will be assessed preintervention and 8 weeks post intervention. The feasibility outcomes will be assessed quantitatively and qualitatively through a questionnaire, videogame dashboard, interviews with a subset of intervention group child–parent dyads and a focus group discussion with nurses and doctors, post intervention, respectively.

Ethics and dissemination The study has been approved by the Ethics Review Committee of the Aga Khan University (2022-6833-21251). Data are accessible only to the research team in a secure form. The findings will be disseminated through publications.

Trial registration number ClinicalTrials.gov Identifier NCT05796895, registered in April 2023.

What is already known on this topic

  • Evidence from high-income countries (HICs) shows that optimum symptom management in children with cancer through digital interventions significantly improves their health-related quality of life.

  • Among several interventions, videogame-based interventions have demonstrated efficacy in the HICs.

What this study hopes to add

  • The study will add to the scientific knowledge on the clinical efficacy and feasibility of the videogame intervention on children with cancer from a lower-middle income country Pakistan.

  • A mixed methods approach will help understand the research problem and the best possible practical solutions.

How this study might affect research, practice or policy

  • If the intervention efficacy is established, it will improve the healthcare practice through a digitally mediated intervention.

  • It will enhance nurses’ role in educating and promoting innovative strategies for symptom management among children with cancer.

Introduction

Approximately 400 000 children aged up to 19 years are estimated to be diagnosed with cancer annually worldwide.1 With the global rise in the incidence of childhood cancer worldwide, lower-middle income countries (LMICs), including Pakistan, suffer a disproportionate burden.2 3 The National Cancer Registry reveals that approximately 17 457 children are diagnosed with cancer in Pakistan yearly.4 Global evidence suggests that 8 out of 10 children may get completely cured of childhood cancer on receiving evidence-based, accessible treatment and support services.5 Although cancer treatment is complex and lengthy, children respond better to treatment than adults and reach survivorship.5 Early identification and treatment of childhood cancer through multimodality therapies is critical for better survival. Chemotherapy and radiation are the most common treatment modalities for childhood cancers.5 However, these therapies result in severe cancer treatment-related symptoms, compromising children’s daily functioning and health-related quality of life (HRQOL).6 7

Several studies suggest that children with cancer below 18 years of age report similar treatment-related symptoms affecting physiological and psychosocial domains of their HRQOL.8 9 Common physiological problems include pain, fatigue, Gastrointertinal-related symptoms, hair loss and infection.9–11 Commonly reported psychosocial symptoms include anxiety, depression and isolation from friends.9–11 Children’s school attendance and academic progress are also affected during their treatment, which has future implications for them.12

Suboptimal symptom management negatively affects children’s physiological and psychological health, cognitive functions, academic performance, social relationships and overall HRQOL and well-being.12 13 Additionally, poor symptom management can have implications for delayed or abandoned treatment, poor treatment tolerance, unnecessary frequent emergency visits and poor psychological outcomes.13–15 Therefore, education and support about symptom management are critical to optimising children’s HRQOL and preventing symptom worsening.7 16

During the prolonged trajectory of childhood cancer, the responsibility of treatment-related symptom management keeps switching from healthcare providers in the hospital to the children and their parents at home. Effective symptom management at home leads to better symptom outcomes, treatment adherence, less morbidity, fewer rehospitalisations and improved HRQOL among children.17 18 Studies have shown that children who actively participate in learning about self-management of their symptoms understand their disease well, have better preparedness to manage their symptoms and contribute to more informed health decisions.19 20 Developmental psychology theories highlight that children learn best when engaged in activity and play.21–23 Digital technologies such as interactive mobile apps, virtual reality, and videogames allow children to engage in their learning. For these reasons, healthcare providers have started using digital devices in children with asthma, diabetes, cancer and other chronic health conditions to educate them about symptom monitoring and management.17 24

Studies from high-income countries have shown that implementing Digital Health Interventions (DHIs) has significantly improved the HRQOL,18 25 26 knowledge,20 self-efficacy20 and has decreased pain and fatigue,18 anxiety and depression27 in children with cancer. Among various DHIs, videogames have emerged as one of the promising modes of education to help children learn symptom management. The evidence regarding the efficacy of DHIs, especially from LMICs, is still limited, and more studies are recommended to determine the efficacy of these interventions on the health outcomes of children with cancer. To our knowledge, no similar study has been conducted in Pakistan. The aim of this study, therefore, is to develop a videogame intervention for children (age 8–18 years) with cancer and test its clinical efficacy concerning HRQOL and cancer treatment-related symptoms in children, and also to observe the feasibility of the intervention in terms of acceptability, appropriateness, cost and intervention fidelity.

Symptom management theory (SMT)

As shown in figure 1, the SMT comprises three interrelated concepts: (1) symptom experience, (2) symptom management strategies and (3) symptom status outcomes. Symptom experience explains the perception of change in a patient’s usual health status. Symptom management strategies are approaches used to prevent, delay or lessen the symptom experience. Symptom outcomes are measurable outcomes, such as improvement in the HRQOL or recovery from illness, assessed preimplementation and post implementation of a symptom strategy.28

Figure 1
Figure 1

Symptom management theory.28

In accordance with the SMT, in the first phase of the study, we identified the experience of symptoms from child–parent dyads and symptom management strategies from them and the relevant literature. The findings informed the development of the videogame in the second phase of the study. In the third phase of the study, we plan to teach symptom management to children through a videogame intervention and assess their HRQOL and symptom frequency and distress.

Methods and analysis

Design

As shown in figure 2,29 this study employs a mixed methods design (qual → QUAN) having three phases:

  1. Phase I—need assessment.

  2. Phase II—videogame intervention development.

  3. Phase III—videogame intervention testing.

Figure 2
Figure 2

Study design.29

Study phase I—need assessment

In phase I of the study, a qualitative descriptive exploratory design was used to understand the experiences and perceptions of children with cancer and their parents regarding children’s HRQOL, treatment-related symptoms, management strategies and preferences informing the development of the videogame. In-depth interviews were conducted with 28 participants (14 child–parent dyads). Participants elicited strategies for the management of the following symptoms and healthy behaviours to be translated into the videogame: pain, fever, mucositis, nausea, vomiting, hair loss, missing school, throat irritation, constipation, staying physically active, keeping balance between rest and activity, knowing alarming signs, preventing infection, eating healthy, fighting sickness and maintaining psychological and spiritual health.

Study phase II—videogame intervention development

During phase II of the study, a multidisciplinary team comprising children with cancer, parents, clinical experts (oncology nurses and physicians) and digital design specialists (videogame developers and information technologists) collaborated in an iterative design process for the videogame. A series of brainstorming sessions employed an iterative methodology to refine the game’s content, visual design and narrative flow (storyboard). On development completion, user acceptance testing (UAT) was conducted with the child participants, parents and research team members. This UAT phase served to identify and rectify any software bugs or usability issues within the videogame.

Features of the videogame

As shown in figure 3, in the game, a player (study participant) enters the game and selects language (English or Urdu), gender (boy or girl), and environment (city or town). After selecting the avatar, the game interface opens, and a Mascot (a gender-neutral cartoon character—bunny) welcomes the child. The Mascot provides the player with necessary instructions about the gameplay.

Figure 3
Figure 3

The videogame interface.

There are 14 levels in the videogame. The child plays each level, which _targets one symptom for which the child is taught symptom management or health behaviour. Moreover, feedback messages also pop up on the videogame screen to highlight the significance of the action performed. With that, the player progresses to the next level. Each day, the player can unlock two to three game levels. The game content is the same for all children; however, few variations are kept for younger (8–12 years old) and older children (13–18 years old). For example, some game levels provide more lifelines and hints to younger children. The videogame is autolocked at 30 min for younger children to avoid exceeding the screen time limit. Younger children can play two game levels daily, whereas older children can play three. While older children can navigate the game icons, a tutorial about the gameplay is provided to younger children. Table 1 presents the game levels, symptoms and concerns, and details about game levels.

Table 1
|
The videogame levels, symptoms and concerns, and details about the game

Study phase III—intervention testing (Pilot-RCT)

There are two objectives of this phase.

  1. To determine the efficacy of the videogame intervention on the HRQOL and cancer symptoms frequency and distress of children with cancer in the intervention group as compared with the children in the attention control group at preintervention and 8 weeks post intervention.

  2. To determine the intervention feasibility outcomes: acceptability, appropriateness, cost, feasibility and fidelity.

Design

A pilot randomised controlled trial (Pilot-RCT) with an attention control will be used to attain the set objectives.

Study setting

The study is conducted at the Aga Khan University Hospital’s (AKUH) inpatient and outpatient chemotherapy and radiation therapy units. The AKUH is a not-for-profit, resource-intensive, tertiary care and Joint Commission International accredited university hospital recognised for providing high-quality, compassionate care for several specialty services. The oncology department offers specialised cancer services.30 There is one inpatient clinical area for chemotherapy and two outpatient areas for radiation and chemotherapy for children. In the inpatient area, there are separate beds assigned for children for chemotherapy.30

Study population

Children having cancer and receiving chemotherapy or radiation are the study population.

Inclusion criteria
  • Children aged 8–18 years.

  • Diagnosed with any type and stage of cancer within 6 months.

  • Can comprehend Urdu or English language.

  • Have access to an Android smartphone/tablet for at least 30 min/day.

Exclusion criteria
  • Critically ill children.

  • Receiving palliative treatment.

  • Have any diagnosed sight, hearing, cognitive impairment or upper limb deformity.

  • If already playing any videogame with similar content.

The eligibility criterion was selected based on existing literature indicating poor HRQOL in children across all age groups and cancer types and stages.9 31 32 Additionally, as this is an educational videogame, it will be provided to all children over 8 years old experiencing cancer symptoms to educate them about symptom management. Narrowing the inclusion criteria could limit the generalisability of the study’s findings. Randomisation will address the distribution of demographic and clinical variables in both groups.

Sample size and sampling technique

The sample size was calculated for the primary outcome of HRQOL. Keeping the study power at 80%, significance level at 5%, maximum SD of 18.618 and true difference value of 13.5 points,17 a sample of 31 patients per group is desired for this study. Adjusting for 10% attrition, the final sample size is 35 patients per study group. For a pilot trial, a sample size of 35 participants per study group is considered adequate.33 Children will be selected using a non-probability purposive sampling technique.

Participant recruitment

A research associate (RA) will screen potential study participants using the patients’ list available at the inpatient and outpatient oncology units and through communication with the staff nurses. The RA will assess the child for eligibility and explain the study to them and will approach the child in the presence of the parent. The RA will explain the study and random allocation to any study group. The child’s written assent and parent’s consent will be obtained if they agree to participate.

Randomisation, blinding and allocation concealment

Children will be randomised in a 1:1 ratio to the intervention or attention control group. Using a computer-generated randomisation scheme, a random block of 4 and 6 will be used. A person, not a research team member, will generate the randomisation list and prepare sealed and opaque envelopes, ensuring allocation concealment. The RA will open the envelope in front of the child/parent. Further steps would follow according to the child’s assignment. The study will be non-blinded as group assignments cannot be hidden from the participants and research team members in a behavioural intervention.34

Intervention group

Children in the intervention group will receive the videogame for 8 weeks. The RA will provide instructions about the videogame. S/he will call the child and parent every week to ensure participant adherence in the study and to inquire if they have any questions related to the videogame content or worsening of symptoms and will answer in consultation with the clinical expert (oncologist in the research team). A call log of the conversation will be maintained.

Attention control group

The attention control group will be selected to ensure that the study outcomes are not attributable to the unequal attention given to the intervention group.35 Children will receive weekly WhatsApp messages on healthy behaviours based on the National Cancer Institute’s guidelines for childhood cancer. The RA will call the child and parent weekly to inquire about the child’s health, and a call log of the conversation will be maintained.

Figure 4 presents the Consolidated Standards of Reporting Trials (CONSORT) flow diagram.

Figure 4
Figure 4

Consolidated Standards of Reporting Trials flow diagram. HRQOL=, health-related quality of life.

Study outcomes

Primary outcome—HRQOL

The HRQOL of children with cancer will be assessed using the Pediatric Quality of Life Inventory Generic Core Scale (PedsQL 4.0) and Cancer Module (PedsQL 3.0).

The PedsQL 4.0, already available in Urdu, is provided by the MAPI Research Trust. We conducted the Urdu translation of PedsQL 3.0 following MAPI Research Trust guidelines, and it has been approved for use in this study. The Content Validity Index for PedsQL 3.0 is 0.70 for reliability and 0.74 for clarity. The approved Urdu versions of both tools will be used in the study. The tools will be pretested on 10% of the sample (n=7 children). Their data will be excluded from the analysis. The post-hoc reliability measures of the tools in our sample will be reported.

Secondary outcome—cancer symptoms frequency and distress

The cancer symptoms frequency and distress will be assessed using the Memorial Symptom Assessment Scale Short Form.

Feasibility outcomes

The following feasibility outcomes will be assessed: intervention acceptability, appropriateness, cost, feasibility and fidelity.

Data collection

The primary and secondary outcomes will be assessed at preintervention (Baseline) and 8 weeks post intervention (Endline) using quantitative tools. The feasibility outcomes will be assessed 8 weeks post intervention using quantitative and qualitative measures. Moreover, participants’ sociodemographic information will be obtained via a checklist.

Table 2 presents the study outcomes, data collection tools and data ascertainment time points.

Table 2
|
Study outcomes, tools and data ascertainment time points

Data management

The data will be entered in the Statistical Package for Social Sciences, double-entered, secured and managed by the research team.

Data analysis plan

The intention-to-treat (ITT) principle of analysis will be used to preserve the benefits of randomisation. Analysis conducted through ITT will also reflect effectiveness of the intervention in praxis. Depending on the data distribution, continuous variables will be reported as means and SD or medians and IQRs as appropriate. The categorical variables will be reported as frequencies and proportions. The intervention efficacy will be reported using Cohen’s d. The associations between independent and dependent variables will be conducted through regression analysis. The group differences will be calculated through independent samples t-test/Mann-Whitney U test as appropriate. A subgroup analysis will be performed to compare sociodemographic and clinical variables and their impact on children’s HRQOL. No interim analysis is planned. The details are summarised in table 3.

Table 3
|
Plan of data analysis

Study rigour

The CONSORT extension guidelines36 will be used to report the process and findings of the study.

Patient and public involvement

The parents, children with cancer, doctors and nurses were involved in developing the interview guide for the study phase I. The PedsQL 3.0 was translated into Urdu, and parents and children were involved in assessing the items’ readability and comprehension. The videogame was developed with input from parents, children, doctors, nurses and digital health experts.

Ethics and dissemination

The study has received ethical approval from the Ethics Review Committee of the study setting (2022-6833-21251). The study PI (first author) will train the research staff on the study and ethics. Our research team has two paediatric clinical oncologists who will help identify children at risk in critical stages and manage them as necessary. Written informed assent and parental consent are being obtained from children and their parents for participation in the interviews, UAT, Pilot-RCT and postintervention interviews. Written informed consent will also be obtained from the healthcare providers before the focus group discussion (FGD). Participants are being explained about their withdrawal from the study without any ramifications. Principles of confidentiality, privacy and anonymity will be maintained by providing unique identification numbers and pseudonyms to the participants for the questionnaires, FGDs and interviews, respectively. Any adverse events or changes to the protocol will be communicated to the ERC. The study data will be encrypted and remain in the custody of the research team members only. Moreover, only aggregated study findings will be disseminated through publications.

  • Contributors: SSajjad was responsible for the conception and design of the study. She led the finalisation of the study protocol, ensuring its methodological rigour and alignment with research objectives. SSajjad also obtained approvals from ERC, clinicaltrials.gov, and the study setting, and wrote the manuscript. RB and RG supervised and mentored SSajjad throughout the study, refining the study protocol and providing critical input on the manuscript. SSayani mentored SSajjad, providing oversight for the development and deployment of the videogame. ZF and ANA contributed to finalising the study protocol and content of the videogame, and they will direct the operational implementation of the intervention in the clinical setting. All authors have reviewed the manuscript. SSajjad is responsible for the overall content (as guarantor).

  • Funding: This work was supported by the following funders/sponsors for the conduct of the study: (1) Sigma Theta Tau International (STTI) Honor Society of Nursing Small Grant (NA); (2) The Aga Khan University PhD start-up funds (NA); (3) Foundations for Health and Empowerment Pakistan grant (NA); (4) The Aga Khan University Research Council grant (Project ID: 231017); (5) Extramural support (NA).

  • Competing interests: No, there are no competing interests.

  • Patient and public involvement: Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review: Not commissioned; externally peer reviewed.

Data availability statement

Data sharing not applicable as no datasets generated and/or analysed for this study. This is the study protocol and there are no data available yet for the Pilot-RCT.

Ethics statements

Patient consent for publication:
Ethics approval:

The study is approved by the Aga Khan University Ethics Review Committee (ERC). The reference number is 2022-6833-21251. Participants gave informed consent to participate in the study before taking part.

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  • Received: 13 April 2024
  • Accepted: 29 September 2024
  • First Published: 16 October 2024

  NODES
Association 2
Bugs 1
INTERN 2
Note 2
Project 1