Play-based physical activity for preschoolers with cancer
Rehabilitation Including Structured Active Play for Preschoolers With Cancer.
This study is testing if a fun play-based exercise program can help improve movement skills in preschoolers who have just been diagnosed with cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 12 Months to 5 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT04672681 on ClinicalTrials.gov |
What this trial studies
This project investigates the effectiveness of a play-based physical activity intervention aimed at improving gross motor functioning in preschool children diagnosed with cancer. The trial will include 84 children aged 1-5 years who are newly diagnosed and will be randomized into either an intervention group or a control group. The primary outcome will be measured using the Peabody Developmental Motor Scales, Second Edition (PDMS-2) six months after diagnosis. The goal is to reduce the physical and psychosocial consequences of cancer treatment, enhancing both motor skills and social interactions.
Who should consider this trial
Good fit: Ideal candidates are children aged 1-5 years diagnosed with cancer or benign disorders and undergoing chemotherapy or radiation at the University Hospital Copenhagen.
Not a fit: Patients with mental disabilities that complicate their ability to follow instructions may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the physical and social development of young children undergoing cancer treatment.
How similar studies have performed: Previous studies have shown success with play-based interventions in improving gross motor function in healthy preschool children, suggesting potential for similar outcomes in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children diagnosed with cancer or benign disorders and are being treated with chemotherapy and/or radiation and are admitted to the Department of Pediatric Hematology/Oncology at University Hospital Copenhagen, Rigshospitalet. * Children at the age of 1-5,9 years at diagnosis. * Children whose parents can communicate in Danish. Exclusion Criteria: * Children with mental disabilities that complicates the ability to follow instructions.
Where this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Hanne B Larsen — Rigshospitalet, Denmark
- Study coordinator: Anna Pouplier
- Email: anna.pouplier@regionh.dk
- Phone: 004528111998
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.