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Behavioral Intervention

Intervention for Telemedicine (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

PEACE Trial 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.Check my eligibility

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.See study design

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.

PEACE Trial 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.

PEACE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Retention rate

Secondary outcome measures

Acceptability

Adherence to study intervention

Adverse events

+2 more

PEACE 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

~1460

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

890 Previous Clinical Trials

385,030 Total Patients Enrolled

Alberta Health servicesOTHER

158 Previous Clinical Trials

649,656 Total Patients Enrolled

Margaret McNeely, PhDPrincipal InvestigatorUniversity of Alberta

5 Previous Clinical Trials

246 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study have an age restriction that excludes individuals under the age of 40?

"Individuals aged between 4 and 17 years are eligible for enrollment in this clinical trial."

Answered by AI

Which individuals would be considered ideal candidates for participation in this clinical research study?

"This study seeks 10 eligible participants aged 4 to 17 to engage in telemedicine services. Specifically, candidates must fulfill the subsequent requirements: Currently undergoing or having completed cancer therapy as defined by the Children's Oncology Group;, Pediatric individuals diagnosed with acute lymphoblastic leukemia between the ages of 4 and 17 (at diagnosis) along with their parent, guardian, or primary caregiver;, Possession of internet access via a household computer or tablet;, The child has obtained approval from their treating oncologist to partake in this initiative., Capability for English language communication and comprehension among patient or caregiving individual;."

Answered by AI

What is the upper limit for the total number of individuals involved in this research investigation?

"Indeed, the details on clinicaltrials.gov imply that this clinical research is presently seeking suitable candidates. The trial was initially made public on April 15th, 2024, with the most recent update dating back to April 23rd, 2024. Recruitment aims to enroll a total of 10 participants from one designated site."

Answered by AI

Is the enrollment of participants currently ongoing for this research study?

"Indeed, the information available on clinicaltrials.gov confirms that this investigation is actively seeking eligible participants. Originally shared on April 15th, 2024, and last revised on April 23rd, 2024, the trial aims to enlist a total of 10 patients at one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pediatric Early Rehabilitation in Acute Lymphoblastic Leukemia

2024. "Pediatric Early Rehabilitation in Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06170385.

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