NCT07398677

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
28mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Feb 2026Sep 2028

First Submitted

Initial submission to the registry

January 30, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

February 20, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

January 30, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

School AttendanceSocial well-beingRobotTelepresenceCancerSchoolChildrenSchool Navigation

Outcome Measures

Primary Outcomes (1)

  • School Attendance

    School attendance is measured as the percentage of days attended out of the total number of possible school days. School navigators are instructed to assess school attendance at regular monthly intervals. At each time-point, the school navigator will ask about school attendance during the previous week (at the school of origin, hospital school, or teacher-led homeschooling). If a scheduled monthly assessment coincides with periods when the child is on holiday or hospitalized, the assessment will be conducted during one of the adjacent school weeks (i.e., the week before or the week after). This adjustment applies only if the child misses more than two school days during the assessment week. Holidays and periods of hospitalization are considered legitimate absences and will be accounted for in the calculation of the total number of possible school days. To be included in the analysis, a minimum registration of 25 possible schooldays is required per child.

    From enrollment to the end of treatment at 8 months

Secondary Outcomes (2)

  • Social Well-Being

    At enrollment, 8 months after inclusion

  • Academic Level

    At enrollment, 8 months after inclusion

Other Outcomes (4)

  • School Well-Being

    At enrollment, 8 months after inclusion

  • Self Efficacy

    At enrollment, 8 months after inclusion

  • Robot-use

    From enrollment to the end of treatment at 8 months

  • +1 more other outcomes

Study Arms (2)

Arm A: Intervention Group

EXPERIMENTAL

Arm A: will in addition to standard care receive a (1) school navigator, (2) a teleteaching program and technical support, and (3) a telepresence robot.

Device: Telepresence robotOther: School NavigatorOther: Teleteaching and technical support

Arm B: Comparator group

ACTIVE COMPARATOR

Arm B: will in addition to standard care receive a (1) school navigator.

Other: School Navigator

Interventions

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.

Arm A: Intervention Group

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.

Arm A: Intervention GroupArm B: Comparator group

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.

Arm A: Intervention Group

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Children and adolescents are eligible for inclusion if they meet the following criteria: they are: (1) diagnosed with cancer or cancer-like diseases withing two months of inclusion (e.g., benign brain tumors, MDS, or LCH ); (2) have undergone a stem cell transplant, or have experienced cancer relapse or disease progression within the two months of inclusion; (3) aged 5-17 years; (4) admitted to the pediatric oncology ward at Copenhagen University Hospital, Aarhus University Hospital, or Aalborg University Hospital; (5) expected to experience disrupted schooling, defined as absence of more than one school day per week over an anticipated period of eight months; and (6) enrolled, or expected enrolment, in a school in Denmark during the eight month intervention period. Participants will be excluded if: (1) the children in intervention arm B obtain a telepresence robot outside of the SchoolCare intervention; (2) the child is unable to communicate in Danish; or (3) the child has physical or cognitive impairments that prevent them from operating or meaningfully engaging with the telepresence robot. Assessment of the latter criterion will be conducted jointly by hospital personnel and the school navigator to determine whether the child is likely to benefit from participation in the intervention. All reasons for exclusion will be documented and reported in accordance with CONSORT guidelines \[47\] supplemented by the CONSORT-SPI extended version of social and psychological interventions \[48\]. Parents and teachers of the participating children will also be included in the study and invited to complete questionnaires as well as take part in semi-structured interviews. Recruitment began on February 1st, 2026.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Aalborg Universitetshospital

Aalborg, Denmark

RECRUITING

Aarhus Universitetshospital

Aarhus, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The randomization procedure is stratified by site (Copenhagen University Hospital or Aarhus University Hospital/Aalborg University Hospital) and diagnosis (CNS tumor or other cancerous disease). The school navigator and study nurses, responsible for enrolling the children, are blinded to the randomization process. Randomization of the study participants is conducted through REDCap's randomization module, where a random allocation table is generated by a statistician in the research team who, as well as the rest of the research team, is blinded to the randomization table. 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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 10, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

following the final analyses of the study, the IPD will be available upon request

Shared Documents
STUDY PROTOCOL, SAP

Locations