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Behavioral Intervention

Physical Therapy for Pediatric Cancer (PEACE Trial)

N/A

Recruiting

Led By Margaret McNeely, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a combination of in-person and virtual physiotherapy sessions using an online platform is practical and well-received for children with acute lymphoblastic leukemia. Researchers want to know

Who is the study for?

This trial is for children aged 4-17 diagnosed with acute lymphoblastic leukemia, who are undergoing or have completed cancer treatment. They must have internet access and be approved by their oncologist to participate. A parent or caregiver must speak and understand English.

What is being tested?

The study is testing a hybrid physical therapy program combining in-person sessions with virtual ones via the HEAL-ME online platform. It aims to assess if this mixed approach is workable and acceptable for young patients and their families.

What are the potential side effects?

Since the intervention involves physical therapy, potential side effects may include muscle soreness, fatigue, or discomfort during exercises. However, these are typically mild and manageable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am following or have completed a cancer treatment plan approved by the Children's Oncology Group.

Select...

I am a child aged 4-17 with acute lymphoblastic leukemia, or I am their parent/carer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Retention rate

Secondary study objectives

Acceptability

Adherence to study intervention

Adverse events

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical Therapy

2020

Completed Phase 4

~1280

0 / 2Eligibility criteria met