Exercise and Pain in CCS

Penn State Health

Status: Completed

Conditions: Childhood Cancer Survivors

Treatments: Other: Standard post-cancer directed treatment care control; Behavioral: Physical activity intervention coupled with standard post-cancer directed treatment care

Study type: Interventional

Funder types: Other

Identifiers

NCT05562193

STUDY00020762

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

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

Experimental group

Treatment:

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

Standard post-cancer directed treatment care control group

Other group

Treatment:

Other: Standard post-cancer directed treatment care control