Clinical trial NCT05562193: Exercise and Pain in CCS
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer Survivors
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Four Diamonds Research Fund at Penn State Health Childrens Hospital
First posted: 2022-09-30
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Acceptability of the intervention
timeFrame: Baseline
measure: Feasibility of the intervention
timeFrame: Baseline to week 16
Secondary outcomes:
measure: Measure changes in chronic pain levels
timeFrame: Baseline, week 8 and week 16
measure: Measure changes in cumulative dose of pain medications
timeFrame: Baseline, week 4, week 8, week 12 and week 16
measure: Measure changes in patient reported outcomes
timeFrame: Baseline, week 8 and week 16
measure: Measure changes in physical activity level
timeFrame: Baseline, week 8 and week 16
measure: Measure changes in patient functional outcomes (6-min walking test)
timeFrame: Baseline and week 16
measure: Measure changes in patient functional outcomes (30-second chair stand test)
timeFrame: Baseline and week 16
measure: Measure changes in patient functional outcomes ("Timed Up and Go" test)
timeFrame: Baseline and week 16
measure: Measure changes in patient functional outcomes (grip strength test)
timeFrame: Baseline and week 16
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health Children's Hospital
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Smita Dandekar, MD
role: PRINCIPAL_INVESTIGATOR
References: