Social and Physical Activity as Rehabilitation for Preschool Kids With Cancer

Sponsor
Rigshospitalet, Denmark
Study ID
NCT07213024
Status
Not Yet Recruiting

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Conditions

  • Pediatric Cancer
  • Pediatric Cancer Patients

Eligibility Criteria

Sex
ALL
Age
12 Months - 71 Months
Healthy Volunteers
Not accepted

Interventions

  • Facilitated group-structured active play at the hospital — BEHAVIORAL
    The hospital-based part of the intervention includes daily facilitated group-structured active play sessions during the weekdays (i.e., Monday-Friday) at the hospital for 40 weeks. All sessions will be 45 minutes long and structured using the RePlay Model following four core principles: 1) ritual practices; 2) reinforcement of movement through repetition; 3) devel-opment through appropriate challenges; and 4) adjusting activities to accommodate treat-ment-related side effects. All activities are performed together, where healthcare pro-fessionals, parents, and children all participate to support social development. The group-structured active play sessions will take place at the pediatric oncology ward and will be facilitated by a health professional (i.e., an exercise professional or physiother-apist).
  • Parents educational program — BEHAVIORAL
    The parent educational program consists of two educational sessions within the first three months of the child's treatment trajectory. The sessions have the aim of providing the par-ents with knowledge and skills to facilitate structured active play at home: 1. A 30-60-minute session with general information on gross motor function development, common physical side effects of cancer treatment, and the importance of physical activity and active play. 2. A 60-minute practical, interactive introduction to structured active play and the RePlay Model - including inspiration for active play activities they can do at home that challenge different gross motor skills. The parents will receive practical material on gross motor development stages and skills as well as descriptions of active play activities that target gross motor functions.
  • Online facilitated structured active play at home — BEHAVIORAL
    The online facilitated structured active play sessions at home are provided daily during the weekdays (i.e., Monday-Friday) in the afternoon (e.g., 16.00-17.00). A healthcare profes-sional (i.e., an exercise professional or physiotherapist) facilitates these sessions, guiding the families through active play activities following the RePlay Model structure. When the families log on for the online sessions, a healthcare professional will instruct them through different play activities. Each family will receive basic essential home-structured active play equipment (e.g., bean bags, balls, bingo games, items for an obstacle course) for the online sessions. The sessions will be conducted through video connections (Teams or Skype). Families who do not have an iPad or suitable computer will receive an iPad from the research group for the nine-month intervention.

Study Details

Physical activity and play in early childhood are positively associated with healthy growth and gross motor, social, and cognitive development. Preschool children with cancer are at risk of impairments or delays in these interdependent developmental areas. Therefore, it is imperative to find new rehabilitation approaches to ensure preschool children's development during and after treatment. This study is based on the RePlay trial, where results highlight a demand from families for physical activity during cancer treatment and show that preschoolers want to participate. However, there is a need for a more flexible and accessible physical activity initiative at the hospital and greater support and collaboration with parents, also at home. The purpose of this randomized controlled study is to investigate the effect of 9 months of physical activity at the hospital and at home for 82 preschool children with cancer, aged 1-5 years. The rehabilitation program includes the following components: 1. Facilitated structured active play as group sessions at the hospital 2. A parent education program 3. Online facilitated structured active play in the families' homes The included children will be randomized to either a group only receiving structured active play at the hospital (part 1), or a group receiving both structured active play at the hospital, the parent education program, and online structured active play in the families' homes (parts 1-3). We will measure the children's in gross motor function 9 months after the start of treatment (primary outcome), as well as parents' attitudes towards physical activity and the children's general physical function (secondary outcomes). We will measure at treatment initiation, and 6, 9, and 12 months after treatment initiation. Additionally, we will qualitatively investigate the parents and children's experiences, the potential of the rehabilitation program for the children's social development, and the importance of the professional in facilitating structured active play.

Key Dates

First listed
Oct 8, 2025
Start date
Mar 31, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
82 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention arm (a)
    The first intervention arm (a) includes standard care and nine months of facilitated group-structured active play at the hospital. Standard care in-cludes occupational therapy and physiotherapy if needed.
  • Experimental: Intervention arm (b)
    The second intervention arm (b) includes standard care and nine months of facilitated group-structured active play at the hospital combined with a parent educational program and online facilitated structured active play at home. The different intervention components are described in detail below. Standard care includes occupational therapy and physiotherapy if needed.

Primary Outcome Measure

Gross motor function [ Time Frame: At treatment initiation (baseline) and 6, 9 (primary end-point), and 12 months (follow-up) after treatment initiation. ]

Central Contacts

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