Physical Therapy for Pediatric Cancer

(PEACE Trial)

Overseen By Paula Ospina Lopez, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Neurodevelopmental disorders, Genetic disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mixed in-person and online physiotherapy program is feasible and welcomed by children with acute lymphoblastic leukemia (a type of cancer affecting white blood cells) and their parents. The program uses the HEAL-ME online platform to provide personalized physical therapy sessions. It tracks the number of sessions completed and the resources used. Children diagnosed with acute lymphoblastic leukemia, whether in treatment or post-treatment, are suitable candidates if they have internet access and their oncologist approves participation. As an unphased trial, this study offers a unique opportunity to contribute to innovative care approaches that could enhance recovery experiences for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this physical therapy program is safe for children with acute lymphoblastic leukemia?

Research has shown that physical therapy is generally safe for children and teens with cancer. The International Pediatric Oncology Exercise Guidelines confirm that exercise and movement are safe for this group. Many studies indicate that physical therapy can help young cancer survivors improve their strength and stamina. As a result, children who have had cancer can often become stronger and more active with regular physical therapy sessions.

Evidence of harm from physical therapy is minimal. In fact, it is usually well-tolerated, allowing children to join these programs without many issues. Therefore, for those considering a clinical trial involving physical therapy, current research suggests it should be safe and could even help improve physical health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for pediatric cancer focus on medications and surgeries, often neglecting the physical rehabilitation needs of young patients. Researchers are excited about using physical therapy in this context because it emphasizes personalized care, allowing children to choose between in-person and virtual sessions, individually or in groups. This flexibility not only caters to the child's preferences but also integrates their unique symptoms and favorite activities into the therapy, potentially improving engagement and outcomes. This approach aims to enhance the overall well-being of pediatric cancer patients by supporting physical recovery and encouraging active participation in their own treatment journey.

What evidence suggests that this physical therapy program is effective for children with acute lymphoblastic leukemia?

Research shows that physical therapy, which participants in this trial will receive, can greatly benefit children undergoing cancer treatment, including those with acute lymphoblastic leukemia. Studies have found that activity during or after cancer treatment can increase muscle strength, improve breathing, and enhance overall physical abilities. One review found that specific cancer rehabilitation helps manage the negative physical effects of intense cancer treatments. Another study reported that physical therapy improves movement and mobility in young cancer patients. These findings suggest that physical therapy may aid recovery and enhance the quality of life for children with cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Margaret McNeely, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

You have internet access at home using a computer or tablet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week hybrid physiotherapy program with in-person and virtual sessions tailored to individual needs

12 weeks

6 sessions (in-person or virtual)

Follow-up

Participants are monitored for safety, acceptability, and quality of life post-intervention

12 weeks

Long-term follow-up

Monitoring of adverse events and recruitment rate over one year

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Physical Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Published Research Related to This Trial

Only 27.2% of pediatric patients with acute lymphoblastic leukemia (ALL) received physical therapy (PT) within a year of their first hospitalization, highlighting a significant gap in care.

Patients with neuromuscular conditions were more likely to receive PT (58.9%), and factors such as age and type of treating specialist influenced PT utilization, suggesting that targeted interventions could improve access to PT and enhance long-term health outcomes for ALL survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Therapy Utilization Among Hospitalized Patients With Pediatric Acute Lymphoblastic Leukemia. Rodwin, RL., Ma, X., Ness, KK., et al.[2023]

The PAPEC trial involves 60 pediatric cancer patients aged 4 to 18, assessing the effects of a structured exercise program during chemotherapy for solid tumors, aiming to improve fitness and quality of life.

The study will evaluate various health outcomes, including cardio-respiratory fitness and immune function, before, after, and two months post-intervention, potentially highlighting the benefits of exercise in mitigating long-term treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity in Pediatric Cancer patients with solid tumors (PAPEC): trial rationale and design. Soares-Miranda, L., Fiuza-Luces, C., Lassaletta, A., et al.[2013]

In a study of 28 children aged 4-15 with acute lymphoblastic leukemia, those who received five sessions of physical therapy showed significant improvements in ankle dorsiflexion range of motion and knee extension strength after 4 months (P < 0.01).

The results suggest that early physical therapy interventions can enhance important physical functions related to walking, and incorporating more endurance activities may further improve stamina and quality of life for these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of physical therapy intervention for children with acute lymphoblastic leukemia. Marchese, VG., Chiarello, LA., Lange, BJ.[2015]

Physical therapy (PT) is feasible for children undergoing cancer treatment, as indicated by a review of 12 studies, but the current evidence is insufficient to guide clinical practice.

Future research should focus on specific cancer types and related impairments to better understand the benefits of PT, highlighting the need for collaborative multi-centre trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of Physical Therapy Interventions for Childhood Cancers. Ospina, PA., McNeely, ML.[2023]

The guideline emphasizes the importance of implementing standardized exercise interventions for pediatric cancer patients to combat physical inactivity, which can hinder motor development and worsen the side effects of therapy.

It includes 11 recommendations that cover the design of exercise programs, safety issues, and strategies to encourage participation, aiming to improve the overall health and well-being of children undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary Network ActiveOncoKids guidelines for providing movement and exercise in pediatric oncology: Consensus-based recommendations. Götte, M., Gauß, G., Dirksen, U., et al.[2022]

Childhood cancer survivors show significant impairments in active ankle dorsiflexion range of motion, gait, and walking efficiency compared to healthy peers, indicating specific physical limitations despite overall adequate motor performance.

These findings emphasize the need for targeted rehabilitation strategies to address the adverse effects of cancer treatment on physical functioning in pediatric survivors, which could help prevent further limitations in their daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limitations in Ankle Dorsiflexion Range of Motion, Gait, and Walking Efficiency in Childhood Cancer Survivors. Beulertz, J., Bloch, W., Prokop, A., et al.[2017]

Early physical therapy (PT) administered before initial cancer treatment significantly improved health-related quality of life (HRQOL) in children with hematological cancers, while late PT did not show similar benefits.

Both early and late PT groups experienced a decline in exercise capacity, but early PT may help prevent this decline, suggesting that timing of intervention is crucial for optimizing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Early Physical Therapy on Children of School Age With Hematological Cancer: A Quasi-Randomized Controlled Pilot Study. Sonoda, Y., Tobita, R., Ikeda, Y., et al.[2023]

A survey of 35 healthcare professionals in Canada revealed that physical rehabilitation services for children and adolescents with cancer focus on addressing issues like muscle weakness, fatigue, and motor performance limitations, which are common adverse effects of cancer treatment.

Despite recognizing the value of rehabilitation interventions, healthcare professionals identified barriers such as limited resources and the absence of clinical practice guidelines, highlighting the need for improved support and structured protocols in pediatric oncology rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Rehabilitation Practices for Children and Adolescents with Cancer in Canada. Ospina, PA., Wiart, L., Eisenstat, DD., et al.[2021]

Physical therapy in pediatric oncology is shifting towards promoting cardiorespiratory and motor interventions, which can improve patient prognosis, especially in intensive care settings.

The review identified only six relevant studies involving 634 pediatric cancer patients, highlighting a lack of research in this area, but those studies indicated that physical therapy can lead to positive outcomes such as higher discharge rates, reduced mortality, and better management of respiratory issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The performance of physiotherapeutic conducts in oncology patients interned in a pediatric intensive care unit: A systematic review. Roussenq, KR., Lautenschlager, AP., Dubón, AP., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6830414/

A Scoping Review of Physical Therapy Interventions for ... Focused cancer rehabilitation may help children who are experiencing the adverse physical effects of aggressive and prolonged cancer treatments. Physical ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1934148217306597

Improving Functional Mobility in Children and Adolescents ... Rehabilitation can be an important component of promoting improved physical function in children and adolescents undergoing treatment for cancer. Objective. To ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6464400/

Physical exercise training interventions for children and young ... Beneficial effects of physical activity during or shortly after cancer therapy are an increase in muscle mass and plasma volume, improved lung ventilation and ...

4. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2020.00243/full

Benefits of Exercise Training for Children and Adolescents ... The present study provides evidence for a positive effect of combined training in CCPs during intensive cancer treatment.

5. journals.lww.com journals.lww.com/rehabonc/fulltext/2014/32020/a_systematic_review_of_literature__does_concurrent.12.aspx

Does Concurrent Physical Therapy Intervention Have a ... One study produced in our search showed improvements in pediatric cancer patients with concurrent physical therapy intervention. While physical therapy has been ...

6. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21783

Clinical practice guideline and expert consensus ... The International Pediatric Oncology Exercise Guidelines highlight that movement and exercise are safe among children and adolescents living ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/18758894251341150

Provider attitudes and perspectives on rehabilitation ... In a prospective study of over 9000 childhood cancer survivors, less than 9.2% reported physical therapy utilization. Recent studies have ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12314216/

Exploring the Impact of Physical Therapy on Patient ... Mano et al. (2022) reported enhanced physical function and endurance in childhood cancer survivors through long-term rehabilitation [32]. Novel ...

9. journals.lww.com journals.lww.com/rehabonc/fulltext/2025/01000/the__f_words__in_pediatric_oncology__improving.2.aspx

The “F-Words” in Pediatric Oncology While there may be safety considerations related to cancer associated factors, an ever-growing body of evidence has shown physical activity and ...