Physical Activity for Pediatric Cancer

Recruiting at 1 trial location

Overseen By Nicole Culos-Reed, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Completed treatment >3 months, Unable physical activity, Non-English, Parent unavailable

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: 8

Duration: 8-12 weeks

250 Participants Needed

Trial Summary

What is the purpose of this trial?

Physical activity can enhance well-being among youth diagnosed with oncological or hematological diseases. We developed a tailored, 1:1, online physical activity program (i.e., IMPACT), to promote physical activity in this cohort. The proposed single-group, mixed-methods project will assess the effect of IMPACT and explore markers of implementation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Physical Activity, Exercise, Physical Exercise, Physical Activity Intervention for pediatric cancer?

Research shows that exercise interventions for children with cancer are safe and can lead to positive health trends, such as improved physical and psychological well-being, without causing harm. Regular physical activity can help counteract the negative side effects of cancer treatment and support better overall health. ^{1 2 3 4 5}

Is physical activity safe for children with cancer?

Physical activity, including exercise, is generally safe for children with cancer. Studies show that while minor issues like muscle soreness can occur, serious problems are very rare. Supervised exercise programs are recommended to ensure safety. ^{1 3 4 6 7}

How is the physical activity treatment for pediatric cancer different from other treatments?

Physical activity as a treatment for pediatric cancer is unique because it focuses on improving physical and psychological well-being through exercise, rather than using medication. It aims to counteract the negative effects of cancer treatment, such as reduced motor skills and weight gain, by encouraging movement and exercise, which are safe and beneficial for children with cancer. ^{1 6 8 9 10}

Eligibility Criteria

The IMPACT trial is for children and adolescents aged 5-18 with cancer or blood diseases, who are currently in treatment or finished within the last 3 months. They must participate alongside a caregiver.

Inclusion Criteria

I have been diagnosed with cancer or a blood disorder.

I am currently undergoing or about to start treatment for cancer or blood disorders, or I finished treatment less than 3 months ago.

Exclusion Criteria

My parent cannot be with me during my exercise sessions.

I finished my cancer treatment more than 3 months ago.

I am unable to do physical activities as determined by my healthcare team.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive online, individualized physical activity sessions 2-3 times/week for 15-45 minutes/session

8-12 weeks

Online sessions 2-3 times per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments at 6 months and 1 year

Long-term Follow-up

Participants are monitored for long-term outcomes and maintenance of physical activity

1 year

Treatment Details

Interventions

• Physical Activity

Trial Overview This study tests an online physical activity program called IMPACT, designed to improve well-being in young patients with oncological or hematological conditions. It's a single-group study that will also look at how well the program works.

Participant Groups

Group I: Physical activity Experimental Treatment 1 Intervention

Participants will be offered online, individualized physical activity sessions 2-3 times/week for 15-45 minutes/session for 8-12 weeks.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Stollery Children's Hospital

Collaborator

Trials

25

Recruited

25,900+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Alberta Children's Hospital

Collaborator

Trials

58

Recruited

44,700+

Findings from Research

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]

An inhospital exercise program combining aerobic and muscle strength training significantly increased muscle strength in pediatric cancer patients undergoing chemotherapy, with participants showing improvements of 40% in leg press and 24% in bench press after 19 weeks of training.

The program was safe, with no major adverse events reported, and participants maintained an adherence rate of 68%, indicating that exercise can be effectively integrated into the treatment regimen for young cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Intervention in Pediatric Patients with Solid Tumors: The Physical Activity in Pediatric Cancer Trial. Fiuza-Luces, C., Padilla, JR., Soares-Miranda, L., et al.[2022]

A 6-month group-based exercise program for childhood cancer outpatients significantly improved motor performance, activity levels, and emotional well-being compared to those receiving usual care and healthy peers.

This study highlights the potential of structured exercise interventions to enhance physical and emotional outcomes in pediatric oncology patients after their medical treatment ends.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 6-Month, Group-Based, Therapeutic Exercise Program for Childhood Cancer Outpatients on Motor Performance, Level of Activity, and Quality of Life. Beulertz, J., Prokop, A., Rustler, V., et al.[2022]

Exercise interventions for pediatric cancer patients during inpatient treatment show good adherence and positive trends in health status, based on a review of 10 studies involving 204 patients.

No adverse events were reported, suggesting that physical activity programming can be safely integrated into the care of pediatric oncology inpatients to help mitigate the negative effects of inactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise interventions for patients with pediatric cancer during inpatient acute care: A systematic review of literature. Rustler, V., Hagerty, M., Daeggelmann, J., et al.[2022]

A study involving 40 pediatric cancer patients revealed that most participants had positive attitudes towards exercise during treatment and valued a supervised exercise program, indicating a strong desire for physical activity support during hospital stays.

Barriers to exercise included physical, psychological, and organizational challenges, highlighting the need for targeted interventions that address these obstacles and involve education for patients, parents, and healthcare providers about the benefits of exercise in pediatric cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience of barriers and motivations for physical activities and exercise during treatment of pediatric patients with cancer. Götte, M., Kesting, S., Winter, C., et al.[2022]

Physical activity (PA) is safe and beneficial for children and adolescents with cancer, as confirmed by a scoping review of 20 review articles and 69 experimental studies, which showed improvements in various outcomes related to physical, psychosocial, and cognitive health.

Despite some reported adverse events like treatable injuries and fatigue, the overall evidence supports the positive impact of PA, highlighting the need for more rigorous research to better understand its effects and optimize interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesizing the literature on physical activity among children and adolescents affected by cancer: evidence for the international Pediatric Oncology Exercise Guidelines (iPOEG). Wurz, A., McLaughlin, E., Lategan, C., et al.[2021]

In a study of 35,110 exercise interventions for pediatric cancer patients and survivors, serious adverse events (AEs) were rare, with only six Grade 2-3 AEs reported, resulting in an incidence of 17 per 100,000 interventions, indicating that supervised exercise programs are generally safe.

While Grade 1 AEs, such as muscle soreness and circulatory problems, were more common (2,800 per 100,000 interventions), these were typically mild and likely not directly caused by the exercise, suggesting that exercise can be safely integrated into cancer care for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. Gauß, G., Beller, R., Boos, J., et al.[2021]

A review identified 46 physical activity programs for children with cancer across 10 countries, primarily in Europe, indicating a growing international effort to support these children through exercise.

All programs were professionally supervised and most required medical clearance, emphasizing a focus on safety, though there was significant variability in program characteristics such as funding and activity frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity programs for children diagnosed with cancer: an international environmental scan. Wurz, A., Daeggelmann, J., Albinati, N., et al.[2021]

A six-month physical activity program (PAP) for children and adolescents with cancer significantly improved exercise capacity, as measured by the six-minute walk test, with an increase of 86 meters compared to only 32 meters in the control group, indicating strong efficacy.

The PAP was found to be safe with no adverse events reported, and it also led to improvements in self-esteem and quality of life, with benefits persisting even 12 months after the program ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of Physical Activity in Children and Adolescents with Cancer. Saultier, P., Vallet, C., Sotteau, F., et al.[2021]

This study aims to evaluate the effectiveness of active video games in increasing physical activity among children with cancer, targeting 40 patients aged 3 to 16 undergoing treatment with vincristine.

The trial will assess various outcomes, including physical activity levels, motor performance, and fatigue, over a follow-up period of up to 30 months, providing insights into the potential benefits of integrating active video games into cancer treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active video games to promote physical activity in children with cancer: a randomized clinical trial with follow-up. Kauhanen, L., Järvelä, L., Lähteenmäki, PM., et al.[2022]

References

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

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

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

Exercise Intervention in Pediatric Patients with Solid Tumors: The Physical Activity in Pediatric Cancer Trial. [2022]

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

Effects of a 6-Month, Group-Based, Therapeutic Exercise Program for Childhood Cancer Outpatients on Motor Performance, Level of Activity, and Quality of Life. [2022]

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

Exercise interventions for patients with pediatric cancer during inpatient acute care: A systematic review of literature. [2022]

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

Experience of barriers and motivations for physical activities and exercise during treatment of pediatric patients with cancer. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Synthesizing the literature on physical activity among children and adolescents affected by cancer: evidence for the international Pediatric Oncology Exercise Guidelines (iPOEG). [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Physical activity programs for children diagnosed with cancer: an international environmental scan. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A Randomized Trial of Physical Activity in Children and Adolescents with Cancer. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Active video games to promote physical activity in children with cancer: a randomized clinical trial with follow-up. [2022]