Exercise and Pain in CCS

Trial Title: Exercise and Pain in CCS

NCT ID: NCT05562193

Condition: Childhood Cancer Survivors

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomized controlled trial

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Physical activity intervention coupled with standard post-cancer directed treatment care
Description: 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.
Arm group label: Physical activity intervention coupled with standard post-cancer directed treatment care group

Intervention type: Other
Intervention name: Standard post-cancer directed treatment care control
Description: 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
Arm group label: Standard post-cancer directed treatment care control group

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Male and female CCS diagnosed with any type of cancer 2. CCS who have completed all standard/planned cancer treatment and are stable at the time of recruitment 3. CCS are < 1-year post cancer therapy 4. CCS who have chronic pain (pain will be self-reported by the participant, will have to be ≥1 on a scale of 10 and lasting for 3 months or longer) 5. CCS who are age between 10 and 17 years old at the time of enrollment 6. CCS who are and who are not non-ambulatory/wheelchair bound. 7. CCS and parent/legal guardian must be able to speak, read and understand the English language 8. CCS's parent or legal guardian must be able to provide and understand informed consent 9. CCS must be able to provide and understand assent 10. CCS must be able to attend three visits (baseline, 8 and 16-week follow-up) at the Penn State Health Children's Hospital 11. CCS and parent/legal guardian must have access to a computer, smartphone or tablet Note: The agreement of the attending oncologist will be required for the participation of CCS eligible for this study. Exclusion Criteria: 1. CCS who have not completed all standard/planned cancer treatment and/or not in complete remission at the time of recruitment 2. CCS who are > 1-year post cancer therapy 3. CCS who are < 10 years old and > 17 years old at the time of enrollment 4. CCS who have evidence in their medical record of an absolute contraindication to complete any of the physical assessments in their medical record. This exclusion criterion is at the oncologist's discretion when research staff will contact the medical oncologist via secure email or secure message through the electronic medical record for approval to approach their patients for the study and for medical clearance. The oncologists can update this information at any time during the study if there is evidence of an absolute contraindication to complete any of the physical assessments. 5. CCS who have history of refractory or recurrent cancer 6. CCS or their parent/legal guardian who are unable to speak, read, and understand the English language 7. CCS who are unable to access and complete online questionnaires

Gender: All

Minimum age: 10 Years

Maximum age: 17 Years

Healthy volunteers: No

Locations:

Facility:
Name: Penn State Health Children's Hospital

Address:
City: Hershey
Zip: 17033
Country: United States

Status: Recruiting

Contact:
Last name: Smita Dandekar, MD

Phone: 717-531-6012
Email: sdandekar@pennstatehealth.psu.edu

Contact backup:
Last name: Maxime Caru, PhD, PhD

Phone: 717-531-0003

Phone ext: 321480
Email: mcaru@pennstatehealth.psu.edu

Start date: September 30, 2022

Completion date: December 31, 2024

Lead sponsor:
Agency: Milton S. Hershey Medical Center
Agency class: Other

Collaborator:
Agency: Four Diamonds Research Fund at Penn State Health Childrens Hospital
Agency class: Other

Source: Milton S. Hershey Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05562193