Social and physical activity as rehabilitation for preschool kids with cancer-study protocol for a randomized controlled trial.
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BACKGROUND: Preschool children diagnosed with cancer are at risk of delays in motor, cognitive, personal, and social development, all of which are closely connected to being physically active and playing. This study protocol describes the rationale and methods for testing a multimodal intervention in a two-arm, randomized controlled superiority trial. The trial investigates the effect of a 9-month rehabilitation program incorporating physical activity at both the hospital and at home on gross motor function in preschool children diagnosed with cancer. METHODS: The Social and Physical Activity as Rehabilitation for preschool Kids with cancer (SPARK) intervention includes the following components: 1) Supervised group-based social and physical activity at the hospital; 2) A parent educational program, and 3) Online supervised group-based social and physical activity in the families' homes. The group-based social and physical activity is conducted as structured active play. We will include 82 preschool children (aged 1-5 years), newly diagnosed with cancer, who will be randomly assigned on a 1:1 ratio to either group (a) or group (b). Group (a) will receive supervised group-based social and physical activity at the hospital (component 1), and group (b) will receive supervised group-based social and physical activity at the hospital, the parent education program, and online supervised group-based social and physical activity at home (component 1-3). The primary outcome is gross motor function measured using the Peabody Developmental Motor Scales, Third Edition (PDMS-3). Secondary outcomes are parents' knowledge of physical activity and the children's general physical function. Assessments will be conducted at treatment initiation (baseline), and 6, 9 (primary endpoint), and 12 (follow-up) months after treatment initiation. Additionally, we will qualitatively explore the parents' and children's experiences, the rehabilitation program's potential for the children's social development, and the importance of professionals in facilitating structured social and physical activities. DISCUSSION: We expect this study protocol to enhance clarity and transparency while providing insights for clinicians and researchers interested in the gross motor development of preschool children with cancer during treatment. By combining hospital-based and home-based social and physical activity with parental education, this trial has the potential to transform rehabilitation in preschoolers during cancer treatment.