Social and Physical Activity as Rehabilitation for Preschool Kids With Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-71
SponsorRigshospitalet, Denmark

About this trial

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.

Eligibility criteria

Qualifiers

Children newly diagnosed with cancer or cancer-like benign disorders.

Children between the ages of ≥12 to <72 months at the time of treatment initiation.

Children undergoing intravenous chemotherapy and/or radiation therapy and/or immuno-therapy at the Department for Pediatrics and Adolescent Medicine at Copenhagen Univer-sity Hospital-Rigshospitalet.

Disqualifiers

Children diagnosed with severe mental or physical disorders that prevent them from follow-ing instructions in relation to the intervention and testing.

Children where neither of the parents/guardians can communicate in Danish without a translator.

Trial design

Treatments tested in this trial

  • Facilitated group-structured active play at the hospital
  • Parents educational program
  • Online facilitated structured active play at home

Treatment groups

82 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Rigshospitalet, Denmark

Lead sponsor

Danish Cancer Society

Collaborator

Danish Child Cancer Foundation

Collaborator