Clinical trial NCT06170385: Pediatric Early Rehabilitation in Acute Lymphoblastic Leukemia
Official title: Pediatric Early Rehabilitation in ACute Lymphoblastic LEukemia (PEACE): A Feasibility Study of a Hybrid Delivery Format
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Pediatric Cancer
Physical Therapy
Telemedicine
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2023-12-14
Enrollment: 10
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quasi-experimental single group before and after study
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Retention rate
timeFrame: Post-intervention: 12 weeks
Secondary outcomes:
measure: Recruitment rate
timeFrame: One year
measure: Adherence to study intervention
timeFrame: Post-intervention: 12 weeks
measure: Adverse events
timeFrame: One year
measure: Acceptability
timeFrame: Post-intervention: 12 weeks
measure: Health-related Quality of Life
timeFrame: Post-intervention: 12 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Margaret McNeely, PhD
role: PRINCIPAL_INVESTIGATOR
References: