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Exercise and Pain in CCS

NCT05562193 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-05-14

No results posted yet for this 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.

Conditions

  • Childhood Cancer Survivors

Interventions

BEHAVIORAL

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.

OTHER

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

Sponsors & Collaborators

  • Four Diamonds Research Fund at Penn State Health Childrens Hospital

    collaborator UNKNOWN

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Smita Dandekar, MD · Penn State College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2025-03-11
Completion
2025-03-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05562193 on ClinicalTrials.gov