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Protocol Summary


Protocol No.
PSCI-22-084
Prinicipal Investigator
Dandekar, Smita
Phase
Pilot
Age Group
Children
Scope
Local
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
Objective
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.

Aim 1 (Primary): We will examine the acceptability and feasibility of a physical activity intervention coupled with standard post-cancer directed treatment care in young childhood cancer survivors (CCS) 10-17 years old, with chronic pain. Acceptability hypothesis: Greater than 50% of patients approached will agree to study participation. Feasibility hypothesis: Greater than 50% of those randomized to the standard post-cancer directed treatment care with physical activity intervention will complete greater than 50% of the intervention.

Aim 2: We will assess the effects of a 16-week physical activity intervention coupled with standard post-cancer directed treatment care on chronic pain levels and cumulative dose of pain medications. Hypothesis: Patients randomized to the physical activity intervention incorporated into standard post-cancer directed treatment care will experience moderate-to-large magnitude improvements in their self-reported pain scores and reduced cumulative dose of pain medications.

Aim 3: We will assess the effects of the 16-week physical activity intervention with standard post-cancer directed treatment care on patient reported outcomes, including functional and psychosocial outcomes. Hypothesis: Patients randomized to physical activity intervention with standard post-cancer directed treatment care will experience moderate-to-large magnitude improvements in their patient reported outcomes scores.
Applicable Disease Sites
Any Site
Status
Open
Participating Institutions
Hershey Medical Center