NCT06170385

Pediatric Early Rehabilitation in Acute Lymphoblastic Leukemia

Pediatric Early Rehabilitation in ACute Lymphoblastic LEukemia (PEACE): A Feasibility Study of a Hybrid Delivery Format

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the feasibility and acceptability of a hybrid in-person and virtual individualized physiotherapy program using the Healthy Eating and Active Living (HEAL-ME) online platform for children diagnosed with acute lymphoblastic leukemia. We would like to know if this type of hybrid program delivery model is feasible, and if children and their parents are willing and able to participate in the program. We will do this by recording how many, and what type of physiotherapy sessions (in-person or virtual) are completed, what resources offered on the platform are accessed, and how many children complete the assessments.

Detailed description

Acute lymphoblastic leukemia is the most common childhood cancer, representing approximately 25% of cancers in children. Improvements in survival rates have resulted in an increased number of children living with neuromuscular and musculoskeletal side effects of cancer treatments-effects that may persist or worsen over the long-term into adulthood. The overall goal of the study is to determine the feasibility of a tailored physiotherapy (PT) program using an online platform for children diagnosed with acute lymphoblastic leukemia. A quasi-experimental, single group, before and after intervention feasibility study will be conducted, comprising a convenience sample of a minimum of 10 children between 4 and 17 years of age undergoing or having completed chemotherapy treatment for acute lymphoblastic leukemia. Children will participate in a hybrid 12-week PT program delivered in-person at the Stollery Children's Hospital with educational components provided virtually via the Healthy Eating and Active Living web-based platform. Children will participate in six physical therapy sessions over a period of three months and will have the option to choose the mode of delivery: 1:1 in-person, 1:1 virtual, group virtual, or combination of all. The main outcome will be feasibility, as determined by recruitment and retention rates, completion rates of measurements, adherence to sessions, and safety and acceptability.

Conditions

• Neoplasms
• Pediatric Cancer
• Physical Therapy
• Telemedicine

Interventions

Type	Name	Description
BEHAVIORAL	Physical Therapy	Each physical therapy session will commence with a 5-minute warm-up, with fun activities to mobilize the joints and activate the muscles, using the videos available in the HEAL-ME platform. The warm-up session will be followed by a 20 to 40-min program with tailored activities and games comprising jumping, squatting, skipping, balancing, and jogging. The session will finish with a 5-minute cool down with stretching exercises and a relaxation video from the HEAL-ME platform.

Timeline

• Start date: 2024-04-15
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-12-14
• Last updated: 2026-02-06

Locations

1 site across 1 country: Canada