Exercise and Pain in CCS

NCT05562193 | Completed DMC

• 1 other identifier: STUDY00020762
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Acceptability of the intervention

  The number of participants approached who agree to participate in the study

  Baseline

• Feasibility of the intervention

  The number of participants randomized to the physical activity program intervention coupled with standard post-cancer directed treatment care who complete at least 50% of the physical activity intervention.

  Baseline to week 16

Secondary Outcomes (8)

• Measure changes in chronic pain levels

  Baseline, week 8 and week 16

• Measure changes in cumulative dose of pain medications

  Baseline, week 4, week 8, week 12 and week 16

• Measure changes in patient reported outcomes

  Baseline, week 8 and week 16

• Measure changes in physical activity level

  Baseline, week 8 and week 16

• Measure changes in patient functional outcomes (6-min walking test)

  Baseline and week 16

Study Arms (2)

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

EXPERIMENTAL

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

Standard post-cancer directed treatment care control group

OTHER

Other: Standard post-cancer directed treatment care control

Interventions

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

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

Standard post-cancer directed treatment care control 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

Standard post-cancer directed treatment care control group

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female CCS diagnosed with any type of cancer
• CCS who have completed all standard/planned cancer treatment and are stable at the time of recruitment
• CCS are \< 1-year post cancer therapy
• 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)
• CCS who are age between 10 and 17 years old at the time of enrollment
• CCS who are and who are not non-ambulatory/wheelchair bound.
• CCS and parent/legal guardian must be able to speak, read and understand the English language
• CCS's parent or legal guardian must be able to provide and understand informed consent
• CCS must be able to provide and understand assent
• CCS must be able to attend three visits (baseline, 8 and 16-week follow-up) at the Penn State Health Children's Hospital
• 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.

You may not qualify if:

• CCS who have not completed all standard/planned cancer treatment and/or not in complete remission at the time of recruitment
• CCS who are \> 1-year post cancer therapy
• CCS who are \< 10 years old and \> 17 years old at the time of enrollment
• CCS who have history of refractory or recurrent cancer
• CCS or their parent/legal guardian who are unable to speak, read, and understand the English language
• CCS who are unable to access and complete online questionnaires

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Four Diamonds Research Fund at Penn State Health Childrens Hospital: collaborator

Study Sites (1)

Penn State Health Children's Hospital

Hershey, Pennsylvania, 17033, United States

Location

Study Officials

• Smita Dandekar, MD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Smita Dandekar, MD

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 30, 2022
• Study Start: September 30, 2022
• Primary Completion: March 11, 2025
• Study Completion: March 11, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

US (1)