Exercise and Pain in CCS

Last updated: May 8, 2025
Sponsor: Milton S. Hershey Medical Center
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

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

Standard post-cancer directed treatment care control

Clinical Study ID

NCT05562193
STUDY00020762
  • Ages 10-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thetime 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 haveto 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 Englishlanguage

  8. CCS's parent or legal guardian must be able to provide and understand informedconsent

  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 thePenn 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

Exclusion Criteria:

  1. CCS who have not completed all standard/planned cancer treatment and/or not incomplete 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 tocomplete any of the physical assessments in their medical record. This exclusioncriterion is at the oncologist's discretion when research staff will contact themedical oncologist via secure email or secure message through the electronic medicalrecord for approval to approach their patients for the study and for medicalclearance. The oncologists can update this information at any time during the studyif there is evidence of an absolute contraindication to complete any of the physicalassessments.

  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 theEnglish language

  7. CCS who are unable to access and complete online questionnaires

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Physical activity intervention coupled with standard post-cancer directed treatment care
Phase:
Study Start date:
September 30, 2022
Estimated Completion Date:
March 11, 2025

Connect with a study center

  • Penn State Health Children's Hospital

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

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