NeoplasmsPEACENCT06170385
Pediatric Early Rehabilitation in Acute Lymphoblastic Leukemia
A study testing Physical Therapy in people with Neoplasms and Pediatric Cancer, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Neoplasms, Pediatric Cancer, Physical Therapy
- What is being tested?
- Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with acute lymphoblastic leukemia aged between 4 and 17 years (at time of diagnosis) and their mother, father, or primary carer;
- Undergoing or completed cancer treatment as established by the Children's Oncology Group;
- Access to the internet through a home computer or tablet;
- Patient or caregiver is able to speak and comprehend English; and
- The child is approved by their Oncologist to participate in the program.
Who cannot join
- Children with a history of a neurodevelopmental or genetic disorder (i.e., Down syndrome, autism, seizure disorder) prior to the cancer diagnosis; and
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric Early Rehabilitation in ACute Lymphoblastic LEukemia (PEACE): A Feasibility Study of a Hybrid Delivery Format
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.
Read the 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
- Being tested
- Physical Therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate
The number of participants completing the intervention and assessments
Measured: Post-intervention: 12 weeks
Secondary outcomes (5)
Recruitment rate
Number eligible divided by the number of participants enrolling in the study
Measured: One year
Adherence to study intervention
Attendance rates for in-person and virtual physical therapy sessions
Measured: Post-intervention: 12 weeks
Adverse events
Number of serious and non-serious adverse events
Measured: One year
Acceptability
Satisfaction survey
Measured: Post-intervention: 12 weeks
Health-related Quality of Life
Pediatric Quality of Life Inventory Version 4: Total scale score, with higher scores reflecting better quality of life
Measured: Post-intervention: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start15 Apr 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-experimental single group before and after study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Margaret McNeely, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170385
- Sponsor's protocol ID
- HREBA.CC-23-0294
- Acronym
- PEACE
- Status last verified
- Feb 2026
- First submitted
- 6 Dec 2023
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be deposited on the University of Alberta's dataverse
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Early Rehabilitation in ACute Lymphoblastic LEukemia (PEACE): A Feasibility Study of a Hybrid Delivery Format
- ClinicalTrials.gov ID
- NCT06170385
- Acronym / sponsor ID
- PEACE / HREBA.CC-23-0294
- Conditions
- Neoplasms, Pediatric Cancer, Physical Therapy, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-experimental single group before and after study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Physical TherapyChildren 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. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children diagnosed with acute lymphoblastic leukemia aged between 4 and 17 years (at time of diagnosis) and their mother, father, or primary carer;
- Undergoing or completed cancer treatment as established by the Children's Oncology Group;
- Access to the internet through a home computer or tablet;
- Patient or caregiver is able to speak and comprehend English; and
- The child is approved by their Oncologist to participate in the program.
Key exclusion criteria (2 listed)
- Children with a history of a neurodevelopmental or genetic disorder (i.e., Down syndrome, autism, seizure disorder) prior to the cancer diagnosis; and
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyEach 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. | Behavioural | Intervention |
Primary outcome
Retention rate
Time frame: Post-intervention: 12 weeks
The number of participants completing the intervention and assessments
5 secondary outcomes
Recruitment rate
Time frame: One year
Adherence to study intervention
Time frame: Post-intervention: 12 weeks
Adverse events
Time frame: One year
Acceptability
Time frame: Post-intervention: 12 weeks
Health-related Quality of Life
Time frame: Post-intervention: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Yes. Data will be deposited on the University of Alberta's dataverse
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret McNeely, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy in people with Neoplasms and Pediatric Cancer, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate (time frame: Post-intervention: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.