Exercise and Pain in CCS

NCT ID: NCT05562193

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2025-03-11

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Physical activity intervention coupled with standard post-cancer directed treatment care group

Group Type: EXPERIMENTAL

Physical activity intervention coupled with standard post-cancer directed treatment care

Intervention Type: BEHAVIORAL

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.

Standard post-cancer directed treatment care control group

Group Type: OTHER

Standard post-cancer directed treatment care control

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Four Diamonds Research Fund at Penn State Health Childrens Hospital

UNKNOWN

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Smita Dandekar

Dr. Smita Dandekar, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Smita Dandekar, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

Penn State Health Children's Hospital

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY00020762

Identifier Type: -

Identifier Source: org_study_id