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NCT07742059

Overview

NCT ID: NCT07742059
Lead Sponsor: Koç UniversityOTHER
Official Title: Augmented Reality-Supported Cognitive Behavioral Therapy for Children With Cancer: A Three-Arm Randomized Controlled Trial
Brief 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)

Status and Timeline

Status: Completed
Last Update Posted: Aug 3, 2026Actual
Start Date: Apr 1, 2024Actual
Primary Completion Date: Feb 1, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 114Actual
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: No data available
Locations: Akdeniz Üniversitesi Hastanesi

Similar Studies

Participant Group/Arms

AR-CBT (My Hospital Buddy Ida)Experimental

Children received a 12-module, 9-session cognitive behavioral therapy (CBT) and Child Life program delivered through "My Hospital Buddy Ida," a smartphone/tablet augmented reality (AR) application with an interactive AR companion character, in addition to usual hospital care.

Behavioral: Augmented Reality-Supported CBT ("My Hospital Buddy Ida")

Standard CBT (Printed Workbook)Active Comparator

Children received the same 12-module, 9-session CBT and Child Life program content as the AR-CBT arm, delivered through a printed workbook rather than the AR application, in addition to usual hospital care.

Behavioral: Standard CBT (Printed Workbook)

Usual Care ControlNo Intervention

Children continued usual hospital care and oncologic treatment without receiving the structured CBT/Child Life program or the AR application.