Pediatric Early Rehabilitation in Acute Lymphoblastic Leukemia

Neoplasms Clinical Trial

— PEACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170385
• Other study ID #: HREBA.CC-23-0294
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of Alberta
• Contact: Margaret L McNeely, PhD
• Phone: 780-492-6007
• Email: mmcneely[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Children diagnosed with acute lymphoblastic leukemia aged between 4 and 17 years (at time of diagnosis) and their mother, father, or primary carer;

2. Undergoing or completed cancer treatment as established by the Children's Oncology Group;

3. Access to the internet through a home computer or tablet;

4. Patient or caregiver is able to speak and comprehend English; and

5. The child is approved by their Oncologist to participate in the program.

Exclusion Criteria:

1. Children with a history of a neurodevelopmental or genetic disorder (i.e., Down syndrome, autism, seizure disorder) prior to the cancer diagnosis; and

2. Children with a concurrent condition (illness, disease, psychiatric disorder), as determined by oncologist or physiotherapist, that would compromise study participation or interpretation of study results.

Related Conditions & MeSH terms

• Leukemia, Lymphoid
• Neoplasms
• Pediatric Cancer
• Physical Therapy
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Telemedicine

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Alberta Health services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rate	The number of participants completing the intervention and assessments	Post-intervention: 12 weeks
Secondary	Recruitment rate	Number eligible divided by the number of participants enrolling in the study	One year
Secondary	Adherence to study intervention	Attendance rates for in-person and virtual physical therapy sessions	Post-intervention: 12 weeks
Secondary	Adverse events	Number of serious and non-serious adverse events	One year
Secondary	Acceptability	Satisfaction survey	Post-intervention: 12 weeks
Secondary	Health-related Quality of Life	Pediatric Quality of Life Inventory Version 4: Total scale score, with higher scores reflecting better quality of life	Post-intervention: 12 weeks