NCT05562193

Exercise and Pain in CCS

Exercise Intervention Coupled With Standard Post-cancer Directed Treatment Care to Reduce Chronic Pain in Childhood Cancer Survivors Who Have Completed Cancer-directed Therapy Less Than One Year

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Childhood Cancer Survivors

Interventions

Type	Name	Description
BEHAVIORAL	Physical activity intervention coupled with standard post-cancer directed treatment care	CCS will participate in a 16-week physical activity program. CCS will be instructed to start with a session duration of \<15-min, three days per week at low intensity (e.g., activities expending \>1.5 to 3 METs or intensity \<5 on a scale of 0 to 10). Any type of physical activity will be acceptable. The program will be individualized, and activity increased according to patients' health status, results from the physical function assessment, and most recent week's achieved physical activities. The program will include support calls and texts from research staff (exercise physiologist). The program will be modified and adapted during support calls or texts, including frequency, intensity, time and type to maximize CCS' success. CCS will receive a Fitbit at the beginning of the intervention.
OTHER	Standard post-cancer directed treatment care control	CCS in the control group will not participate in a 16-week physical activity program and will not receive support calls or texts. Physical activity advice according to the Children's Oncology Group Guidelines for Diet and Physical Activity recommendations and the International Pediatric Oncology Exercise Guidelines will be offered to CCS following completion of 16-week follow-up. Moreover, CCS will receive a Fitbit following completion of 16-week follow-up

Timeline

• Start date: 2022-09-30
• Primary completion: 2025-03-11
• Completion: 2025-03-11
• First posted: 2022-09-30
• Last updated: 2025-05-14

Locations

1 site across 1 country: United States