Exercise Intervention for Childhood Cancer Survivors

Overseen By Maxime Caru, PhD, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Refractory cancer, Recurrence, Contraindications, others

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

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding exercise to the usual care for young cancer survivors can alleviate pain and enhance overall well-being. Researchers seek to discover whether exercise can reduce pain and the need for pain medication while improving physical and social functioning. The study involves children and teens aged 10 to 17 who completed cancer treatment within the last year and are experiencing ongoing pain. Participants will receive either regular care with added exercise (physical activity intervention) or just regular care. As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding how exercise can improve life after cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, the study aims to decrease the need for pain medications, so it's possible that changes to your medication might be discussed during the trial.

What prior data suggests that this exercise intervention is safe for childhood cancer survivors?

Research has shown that exercise programs for children who have survived cancer are generally safe and manageable. One study found that survivors who participated in supervised exercise sessions continued with the program and found it both safe and helpful. Another study showed that physical activity not only reduces cancer-related fatigue but also improves overall quality of life. These findings suggest that including exercise in post-cancer care is likely beneficial without serious risks. Overall, exercise programs appear safe for young cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the physical activity intervention for childhood cancer survivors because it offers a proactive approach to improving long-term health outcomes, which is different from the usual focus on medical treatments alone. Unlike standard post-cancer care that primarily addresses medical follow-up, this intervention emphasizes the role of exercise in enhancing physical and psychological recovery. By integrating physical activity into the standard care routine, this approach could lead to improved quality of life and reduced risk of secondary health issues, making it a promising addition to post-cancer care strategies.

What evidence suggests that this trial's exercise intervention could be effective for childhood cancer survivors?

Research shows that exercise can greatly benefit children who have survived cancer. In this trial, participants in the physical activity intervention group will engage in regular exercise alongside standard post-cancer treatment care. Studies indicate that being active can reduce fatigue, a common issue after cancer treatment. One study found that children who exercised regularly were more active overall than those who did not. Another study highlighted benefits such as improved heart health, reduced weight gain, and stronger bones. Overall, exercise supports better physical health and can enhance the quality of life for young cancer survivors. ^{1 6 7 8 9}

Who Is on the Research Team?

Smita Dandekar, MD

Principal Investigator

Penn State College of Medicine

Are You a Good Fit for This Trial?

This trial is for childhood cancer survivors aged 10-17 who are less than a year post-cancer therapy, can attend three visits at Penn State Health Children's Hospital, and have chronic pain. They must be stable after completing all planned cancer treatments and able to use a computer or smartphone.

Inclusion Criteria

I have been experiencing pain for over 3 months, and it's at least a 1 out of 10.

CCS and parent/legal guardian must have access to a computer, smartphone or tablet

I can understand and agree to the study's requirements.

Exclusion Criteria

CCS or their parent/legal guardian who are unable to speak, read, and understand the English language

My cancer has come back or didn't respond to treatment.

I finished my cancer treatment more than a year ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a physical activity intervention coupled with standard post-cancer directed treatment care

16 weeks

Baseline, week 4, week 8, week 12, and week 16

Follow-up

Participants are monitored for changes in chronic pain levels, medication usage, and functional outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physical activity intervention
• Standard post-cancer directed treatment care

Trial Overview

The study tests if adding an exercise program to standard care improves pain management and functional/psychosocial outcomes in young cancer survivors compared to those receiving only standard care.

How Is the Trial Designed?

Group I: Standard post-cancer directed treatment care control group Experimental Treatment 1 Intervention

Group II: Physical activity intervention coupled with standard post-cancer directed treatment care group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Four Diamonds Research Fund at Penn State Health Childrens Hospital

Collaborator

Trials

2

Recruited

60+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7778568/

Physical activity for pediatric cancer survivors - PubMed Central

The study found that the program was effective in reducing cancer-related fatigue among Chinese pediatric cancer survivors [33]. Quality of life.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8794406/

Physical activity and fitness in childhood cancer survivors

This scoping review seeks to describe associations between physical activity, physical fitness, chronic disease, and mortality in childhood cancer survivors.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772696725000134

'Making Moves': Protocol for a hybrid effectiveness- ...

The primary aim of this study is to examine the potential effectiveness of 'Making Moves', an online education program combined with tailored exercise support, ...

4.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2793354

Improving Physical Activity in Pediatric Cancer Survivors

They found significant improvement in physical activity compared with the control group at 6 months and 12 months. Results also indicated ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02730767

SURfit - A Physical Activity Intervention for Childhood ...

The objective of this study is to assess the effect of an exercise program of 1 year on cardiovascular health, obesity and diabetes, osteoporosis, physical ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9221732/

Supervised Exercise Interventions in Childhood Cancer ...

Conclusions: The adherence of CCSs to supervised exercise interventions is high, and supervised exercise interventions are safe and effective.

7.

researchprotocols.org

researchprotocols.org/2022/3/e35838/

The Physical Activity and Fitness in Childhood Cancer ...

A modest body of research indicates the effectiveness of PA interventions on PA behavior and physical, psychosocial, cognitive, and social ...

8.

cinj.org

cinj.org/childhood-cancer-survivors-and-physical-activity

Childhood Cancer Survivors and Physical Activity

Research suggests that increased physical activity is associated with lower risk of death and cardiovascular events among childhood cancer ...

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772696725000092

Implementing an online-delivered exercise program for ...

Physical activity levels are low in childhood cancer survivors. Structured physical activity programs are not routinely provided, despite being safe and ...