Social and Physical Activity as Rehabilitation for Preschool Kids With Cancer (SPARK)

1. BACKGROUND Physical activity and play in early childhood are positively associated with healthy growth and development, this includes motor development (e.g., gross motor functions); psycho-social health (e.g., personal development of self-concept and self-esteem); cognitive de-velopment (e.g., language); and social development (e.g., social skills and functioning). Preschool children diagnosed with cancer are at risk of impairments or delays in several of these interdependent developmental areas. Studies have shown impairments of fine- and gross motor skills during treatment for preschool children with cancer, including severe walking difficulties and loss of ability to support themselves on their legs which limit their movement possibilities and development. Furthermore, these children are taken out of their usual social context in daycare, which limits their social interactions with their peers. When the children re-enter everyday life in daycare, they have trouble following along with their peers physically, have less confidence in their movement abilities, lack age-specific social competencies, and feel excluded. Additionally, one study has shown that these im-pairments persist up to two years after treatment, where the children struggle with develop-ing balance skills and more complex motor skills requirements that come with age. Pre-school children make up half of the population of children who are diagnosed with cancer each year; thus, finding novel rehabilitation approaches to ensure preschoolers' develop-ment during and after cancer treatment is imperative.

The present trial is based on the experiences within the research group from the RePlay trial (Rehabilitation including structured active play for preschoolers with cancer); the first and largest trial investigating the effect of structured active play as a physical activity inter-vention specifically developed for preschoolers during cancer treatment. The current find-ings highlight a demand from families for physical activity during cancer treatment and show that preschool children want to participate. However, there is a need for a more flexi-ble and easily accessible (i.e., offered all weekdays, located at the ward close to the pa-tients) physical activity intervention at the hospital to increase participation and support the social potential. Furthermore, emphasis is needed on the home-based part of the interven-tion as treatment protocols and isolation requirements have changed so families are more at home during treatment. Preschool children need to be physically active and move as much as possible every day; thus, this calls for an approach with greater support and col-laboration with parents and increased physical activity at home, such as facilitated online physical activity sessions, which have been shown to increase participation in physical activity in older children with cancer.

Based on our current knowledge and evidence, we have designed Social and Physical Activity as Rehabilitation for preschool Kids with cancer (SPARK)-a randomized con-trolled trial. SPARK includes facilitated group-structured active play at the hospital, based on the RePlay Model, combined with a parent educational program and facilitated online structured active play sessions at home. With this new study, we aim to:

• Primarily investigate the effect of a nine-month physical activity intervention consisting of group-structured active play at the hospital combined with a parent educational program and online structured active play sessions at home on preschoolers' gross motor function development compared with children only receiving group-structured active play at the hospital.
• Secondarily investigate the parents' perception of physical activity and the children's general physical function, and qualitatively explore the children's and parents' experiences with the intervention.

2. METHODS

Design:

SPARK is a single-center, two-armed, randomized controlled trial. We will include 82 preschool children newly diagnosed with cancer, aged 1-5 years old.