Pediatric Early Rehabilitation in Acute Lymphoblastic Leukemia

NCT ID: NCT06170385

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

Children will participate in six PT sessions over the course of 12 weeks and will be provided with the option to choose their preferred mode of the delivery (i.e., 1:1 in-person, 1:1 virtual, group virtual, or a combination of all). The program will be tailored to the child's age, presenting symptoms, and preferred activities.

Children and parents/ caregivers will be encouraged to carry out additional tailored PT sessions through their preferred mode of delivery and to access the exercise videos provided in the additional resources section of the HEAL-ME platform.

Group Type: EXPERIMENTAL

Physical Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alberta Health services

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret McNeely, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Margaret L McNeely, PhD

Role: CONTACT

mmcneely@ualberta.ca

780-492-6007

Paula Ospina Lopez, MSc

Role: CONTACT

frmace@ualberta.ca

780-492-6007

Facility Contacts

Margaret McNeely, PT, PhD

Role: primary

mmcneely@ualberta.ca

780-248-1531

Other Identifiers

HREBA.CC-23-0294

Identifier Type: -

Identifier Source: org_study_id