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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Physical Therapy for Pediatric Cancer?

Research shows that physical therapy can help children with cancer manage side effects like muscle weakness and fatigue. Although more studies are needed, healthcare professionals believe these interventions are valuable in reducing the burden of cancer effects. ^{1 2 3 4 5}

Is physical therapy safe for children with cancer?

Research suggests that physical therapy is generally safe for children with cancer, as it helps manage adverse effects of cancer treatment. However, more studies are needed to establish specific guidelines and protocols for its use in pediatric oncology. ^{1 2 3 6 7}

How is the treatment 'Physical Therapy for Pediatric Cancer' different from other treatments for this condition?

Physical therapy for pediatric cancer is unique because it focuses on improving exercise capacity and quality of life through cardiorespiratory and motor interventions, rather than solely managing symptoms or side effects of cancer treatments. This approach is still developing, with ongoing research needed to establish specific protocols and benefits for different cancer types. ^{1 2 3 8 9}

Research Team

Margaret McNeely, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

A Scoping Review of Physical Therapy Interventions for Childhood Cancers. [2023]

2. Saudi Arabia pubmed.ncbi.nlm.nih.gov

The performance of physiotherapeutic conducts in oncology patients interned in a pediatric intensive care unit: A systematic review. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Physical Rehabilitation Practices for Children and Adolescents with Cancer in Canada. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Physical Activity in Pediatric Cancer patients with solid tumors (PAPEC): trial rationale and design. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of physical therapy intervention for children with acute lymphoblastic leukemia. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Limitations in Ankle Dorsiflexion Range of Motion, Gait, and Walking Efficiency in Childhood Cancer Survivors. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Multidisciplinary Network ActiveOncoKids guidelines for providing movement and exercise in pediatric oncology: Consensus-based recommendations. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of Early Physical Therapy on Children of School Age With Hematological Cancer: A Quasi-Randomized Controlled Pilot Study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Physical Therapy Utilization Among Hospitalized Patients With Pediatric Acute Lymphoblastic Leukemia. [2023]