Trials / Recruiting
RecruitingNCT07398677
SchoolCare: A Social Intervention Introducing Telepresence Robots and School Navigation to Reduce School Fragmentation for Children Undergoing Cancer Treatment
SchoolCare: A Social Intervention Introducing Telepresence Robots and School Navigation to Reduce School Fragmentation for Children Undergoing Cancer Treatment - Study Protocol of a Multi-Site Randomized Controlled Trial (RCT)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- Sponsor
- Rigshospitalet, Denmark · Academic / Other
- Sex
- All
- Age
- 5 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
Advances in pediatric cancer treatment have led to significant improvements in survival rates, where 5-year survival now exceeds 85%. Despite improved survival, children and adolescents who survive cancer often face significant short- and long-term psychosocial and physical late effects. Children undergoing cancer treatment often experience prolonged school absence, which disrupts their academic development and impedes critical socio-emotional growth during formative school years, with lasting consequences into adulthood. Together, these challenges underscore the need for targeted interventions that support educational continuity, promote school activity, and foster psychosocial well-being. The SchoolCare Intervention aims to reduce school absence experienced by children diagnosed with cancer during their treatment trajectory. The intervention introduces school navigation support in combination with the use of telepresence robots (TPRs) and a teleteaching program. TPRs enable the children to attend school remotely, when they are not able to attend physically. The study is designed to investigate the effectiveness of the intervention throughout a period of eight months for school-aged children (i.e., 5-17 years) who are diagnosed with cancer. The investigators hypothesize that telepresence robots will increase school attendance among children and adolescents diagnosed with cancer, representing our primary outcome (H1). Additionally, the investigators explore secondary outcomes by hypothesizing that the intervention will improve the social well-being of these children and adolescents (H2) and enhance their academic level (H3). By focusing on both school attendance and broader psychosocial and academic effects, this study will provide a comprehensive evaluation of the telepresence robot intervention and its potential to support educational continuity and well-being for children with cancer.
Detailed description
Background: Survival rates for children with cancer have increased substantially. As more children survive their cancer diagnosis, attention has shifted to the educational, social, and psychosocial challenges associated with treatment, including fragmented schooling, social isolation, and risk of long-term academic and social difficulties. Despite legislation ensuring access to education during illness, children often face challenges navigating school, hospital, and home educational systems, highlighting the need for coordinated support. Telepresence robots (TPRs) offer an innovative solution by allowing children to participate remotely in classroom activities while maintaining social presence and inclusion. Although TPRs already have been used for children with medical conditions, no studies have rigorously evaluated their impact on school attendance, social well-being, or academic outcomes for children with cancer. The SchoolCare intervention is a multi-site randomized controlled trial designed to address this gap. Methods: The SchoolCare intervention is a multi-site, two-arm parallel group (A and B), randomized controlled trial (RCT). The SchoolCare intervention is being conducted at three out of four pediatric oncology treatment centers in Denmark: Copenhagen University Hospital, Aarhus University Hospital, and Aalborg University Hospital. Recruitment will begin in February 2026. After baseline data collection, participants are randomly assigned to either the intervention arm A or B using centrally administered computer-generated random numbers (via R-studio) with a secure, concealed allocation process conducted in REDCap. The randomization procedure is stratified by site (Copenhagen University Hospital or Aarhus University Hospital/Aalborg University Hospital) and diagnosis (CNS tumor or other cancer, or cancer-like illness). The school navigator and study nurses, responsible for enrolling the children, are blinded to the randomization process, which is conducted by a statistician outside the research team, who is also blinded to baseline data. However, due to the nature of the intervention, neither the research team, school navigator, children, nor their parents or teachers are blinded to group assignment. The intervention comprises three components: (1) a school navigator, (2) a telepresence robot, and (3) a teleteaching program. Participants randomized to intervention arm A will receive all three components in addition to standard care. Participants randomized to intervention arm B will receive the school navigator component only, in addition to standard care. Two school navigators with professional experience in education will support participants in the SchoolCare intervention-one in the eastern part of Denmark (Copenhagen University Hospital) and one in the western part of Denmark (Aarhus and Aalborg University Hospitals). Their role is to maintain children's connection to school and ensure continuous learning during treatment. Navigators coordinate between hospital schools, home, and the child's school of origin, supporting learning plans, facilitating communication with parents, and addressing barriers to participation. Monthly calls with parents are conducted for all participants. Navigators receive training on pediatric cancer, the study design, and their responsibilities prior to the intervention. The two types of telepresence robots are: (1) the AV1, a compact, desk-based robot that supports two-way audio, one-way video streaming with zoom, 360-degree rotation, and head movement, with interactive features such as visual signals and emojis; (2) the BEAM, a larger, floor-based robot that can move around the classroom, offering two-way audio and two-way video streaming on a 10-inch screen with zoom. Participants in intervention arm A will be randomly assigned to receive either an AV1 telepresence robot or a BEAM telepresence robot. Initially, the AV1 is provided for the study participants until the BEAM is available (expected availability of the BEAM is medio February). Once both types of telepresence robots are available for allocation, the type of telepresence robot provided for each child will alternate between the two types of robots. This means that if the previous child within a distinct randomization group was allocated into arm A and received an AV1 telepresence robot, the next child within that same randomization group, who is allocated into arm A, will receive the BEAM telepresence robot. The school navigator will lead a teleteaching program with three components: (1) robot introduction, (2) classroom teleteaching, and (3) ongoing technical support. First, the robot will be introduced to the child, parents, and school staff during an initial meeting. Second, the navigator will conduct a teleteaching class in the classroom to familiarize peers and teachers with the robot, drawing on best practices for human-robot interaction and previous studies on telepresence in school settings. Third, the navigator will provide technical support throughout the eight-month intervention period, appoint a key school contact to coordinate communication, and assign one or two classmates as "robot buddies" to support daily robot integration. Patients will be recruited from February 1, 2026, to February 1, 2028, with an expected sample of \~128 children (\~64 per intervention arm). Randomization will be 1:1 and stratified by oncology site (Copenhagen vs. Aarhus/Aalborg) and diagnosis (CNS vs. other) to ensure balanced allocation. Accounting for an expected 20% dropout rate, the effective yearly sample is \~64 cases. In conducting a sensitivity analysis, the model assuming an alpha of 0.05, a power of 95%, with one primary predictor (i.e., school attendance) and with five covariates, the investigators observe that the statistical setup can detect of small-to-medium effect sizes. School attendance will be recorded at monthly intervals through structured telephone calls conducted by the school navigators. The manual registration will be supplemented by school attendance registers. This multi-site randomized controlled trial aims to generate evidence on how telepresence robots can support school participation and reduce educational fragmentation for children undergoing cancer treatment. By combining remote access to the classroom via telepresence technology with guidance from a school navigator, the study explores innovative approaches to promote both learning continuity and social engagement for children and adolescents diagnosed with cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Telepresence robot | Children in arm A will receive a telepresence robot (either AV1 or BEAM). The children are able to attend their schooling environment through telepresence robots operated via an App installed on a provided study-tablet. Each participant is provided an tablet. AV1 is a compact unit designed to sit on the student's desk in the classroom. It enables real-time, one-way video transmission with zoom functionality combined with two-way audio communication, and allows the user to remotely adjust the robot's orientation, including full rotation and vertical head movement. The second device, BEAM, is a larger, mobile robot positioned on the classroom floor, capable of moving independently within the room at a controlled speed of up to 5 km/h. It offers real-time two-way audio and video interaction via an integrated 10-inch screen with zoom functionality. |
| OTHER | School Navigator | As part of the SchoolCare intervention, the investigators will hire two professionals with formal education and experience within the school system into roles of school navigators. The primary purpose of the school navigators is to ensure continuous education and to maintain a connection to the schooling environment for children and adolescents diagnosed with cancer. To achieve this, the school navigator will (1) establish contact with the school (teachers and principal) along with the child's first hospital discharge; (2) verify the existence of a learning plan, and if absent, assist the school principal in developing and monitoring an appropriate plan for the child; (3) facilitate ongoing communication with parents through monthly calls throughout the eight-month intervention period; (4) organize a transition meeting at the end of the intervention; and (5) identify barriers and facilitators encountered throughout the intervention period. |
| OTHER | Teleteaching and technical support | The school navigator will facilitate a teleteaching program consisting of three components: (1) introduce the robot to parents, school teachers, school principals, and classmates, (2) conduct a teleteaching class where classmates will get hands-on experience with the robot, and (3) provide technical support during the intervention. |
Timeline
- Start date
- 2026-02-20
- Primary completion
- 2028-09-30
- Completion
- 2028-09-30
- First posted
- 2026-02-10
- Last updated
- 2026-03-19
Locations
3 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT07398677. Inclusion in this directory is not an endorsement.