CompletedNot Applicable

My Hospital Buddy Ida: AR-CBT for Children With Cancer

Turkey (Türkiye)114 participantsStarted 2024-04-01

Plain-language summary

The goal of this clinical trial is to learn if an augmented reality (AR) mobile app-based cognitive behavioral therapy (CBT) program can help children aged 6 to 12 years who are being treated for cancer cope with treatment-related distress and improve their quality of life. The main questions it aims to answer are: * Does an AR-supported CBT app improve health-related quality of life compared with the same CBT content delivered on paper, and compared with usual care? * Does the AR-CBT app improve resilience, emotional and behavioral functioning, anxiety, and treatment-related symptoms such as nausea and fatigue, compared with the other two groups? Researchers will compare three groups: an AR-CBT group using a smartphone/tablet app called "My Hospital Buddy Ida," a Standard CBT group receiving the same content through a printed workbook, and a usual care control group, to see if the AR app leads to greater improvement in quality of life and related outcomes. Participants will: * Be randomly assigned to one of the three groups * Complete a 12-module, 9-session CBT and Child Life program (AR-CBT and Standard CBT groups) or continue usual hospital care (control group) * Complete questionnaires about quality of life, resilience, emotional and behavioral symptoms, anxiety, and treatment-related symptoms before and after the program (approximately 9 to 12 weeks later)

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of any childhood cancer * Currently within the first 4 months of chemotherapy treatment * Has completed at least 1 prior chemotherapy cycle * Sufficient Turkish language ability to complete study measures * Presence of a literate caregiver able to provide consent and assist with study procedures Exclusion Criteria: * Chronic illness other than cancer * Diagnosed brain disease * Epilepsy * Severe neurodevelopmental or neurological disorder * Clouded consciousness or delirium * History of motion sickness * Sensory or cognitive impairment precluding use of the AR application

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in PedsQL Cancer Module Total Score - Child Self-Report

Timeframe: Baseline and post-treatment (approximately 9-12 weeks after baseline)

Trial details

NCT IDNCT07742059

SponsorKoç University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-01

View on ClinicalTrials.gov More Pediatric Cancer trials