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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to demonstrate that integration of exercise intervention into standard post-cancer directed treatment care will improve patient reported pain, decrease the need for medications to manage chronic pain and improve functional and psychosocial outcomes in survivors of cancers in children and adolescents. Our central hypothesis is that integration of exercise interventions into standard post-cancer directed treatment care will be acceptable and feasible while improving patients' pain, decreasing the cumulative dose of pain medication and improving patients' functional and psychosocial outcomes as compared to patients who only receive standard post-cancer directed treatment care.

Research Team

Smita Dandekar, MD

Principal Investigator

Penn State College of Medicine

Eligibility Criteria

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.

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

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

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

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

Treatment Details

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.

Participant Groups

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+