CancerNCT05796895
A Videogame Intervention for Children With Cancer
A study testing Videogame and WhatsApp in people with Cancer, run by Aga Khan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cancer
- What is being tested?
- Videogame and WhatsApp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Development and Testing of a Videogame Intervention for Improving the Health-related Quality of Life (HrQOL) of Children With Cancer
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Videogame, WhatsApp
- Keywords
- Childhood cancer, Videogame, Health-related Quality of Life, Mixed Methods, Low and Middle-Income Country
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideogameBehavioural
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.
WhatsAppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Children will be provided with the videogame through which we will teach them symptom management strategies. Receives: 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. Receives: Behavioral: WhatsApp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Children of both groups will be administered the Memorial Symptoms Assessment Scale Short Form at baseline and at eight weeks to assess the change in the symptom frequency and distress. They will be asked to report the frequency (i.e. rarely, occasionally, frequently, almost constantly) and distress (not at all, a little bit, somewhat, quite a bit, very much) of each symptom. (Higher score indicates more distress and frequency).
Measured: Baseline, pre-intervention and eight weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study startMay 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sehrish Sajjad, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796895
- Sponsor's protocol ID
- 2022-6833-21251
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data obtained through this study will be deidentified and findings will be shared in an aggregated form in the reports and publications.
Publications
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.
PubMed 39414341
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Videogame Intervention for Improving the Health-related Quality of Life (HrQOL) of Children With Cancer
- ClinicalTrials.gov ID
- NCT05796895
- Acronym / sponsor ID
- 2022-6833-21251
- Conditions
- Cancer
- Keywords
- Childhood cancer, Videogame, Health-related Quality of Life, Mixed Methods, Low and Middle-Income Country
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: VideogameChildren will be provided with the videogame through which we will teach them symptom management strategies. |
| Attention Control Group | Active comparator | Behavioral: WhatsAppAn 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideogameChildren 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. | Behavioural | Intervention Group |
| WhatsAppChildren 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. | Behavioural | Attention Control Group |
Primary outcome
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).
Time frame: Baseline, pre-intervention and eight weeks post-intervention
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.
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).
Time frame: Baseline, pre-intervention and eight weeks post-intervention
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.
1 secondary outcome
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).
Time frame: Baseline, pre-intervention and eight weeks post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 39414341Sajjad 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.
- Individual participant dataSharing planned: No. Data obtained through this study will be deidentified and findings will be shared in an aggregated form in the reports and publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Videogame and WhatsApp in people with Cancer, run by Aga Khan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sehrish Sajjad, MScN (+92 21 34865429 ext. 5429, sehrish.sajjad@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: Baseline, pre-intervention and eight weeks post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05796895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.