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Protocol Summary


Protocol No.
PSCI-21-016
Prinicipal Investigator
Schmitz, Kathryn
Phase
Pilot
Age Group
Children
Scope
Local
Title
Physical Activity Post-Cancer for Adolescents and Young Adults (PAPAYA) Pilot trial-Quantitative Component
Objective
The Physical Activity Post-Cancer for Adolescents and Young Adults (PAPAYA) trial aims to carry out a pilot randomized controlled trial among 10-17 year-old adolescents and young adults, at least 1 year and up to 5 years post-cancer treatment. The trial will evaluate the effects of a 12 week physical activity intervention to improve patient reported outcomes and physical function, in comparison to a delayed-intervention control group.
Aim 1: We will rigorously apply surveys to assess the effects of the 12 week physical activity intervention on patient-reported outcomes in 10-17 year-old adolescents and young adults at least 1 year and up to 5 years post-cancer treatment.
Hypothesis: Adolescents and young adults randomized to the physical activity intervention will experience larger magnitude improvements in patient reported outcome scores between baseline and 12 week follow-up as compared to adolescents and young adults randomized to the delayed-intervention control group.
Aim 2: We will rigorously conduct physical function tests, to assess the effects of the 12 week physical activity intervention on physical function in 10-17 year-old adolescents and young adults at least 1 year and up to 5 years post-cancer treatment.
Hypothesis: Adolescents and young adults randomized to the physical activity intervention will experience larger magnitude improvements in physical function between baseline and 12 week follow-up as compared to adolescents and young adults randomized to the delayed-intervention control group.

Aim 3: We will examine acceptability and feasibility of the physical activity intervention in 10-17 year-old adolescents and young adults at least 1 year and up to 5 years post-cancer treatment.
Hypothesis: Greater than 50% of those randomized to the physical activity intervention will accept the intervention. Greater than 50% of those randomized to the physical activity intervention will complete greater than 50% of the physical activity intervention.
Aim 4: We will collect all costs of carrying out the physical activity intervention.
This is a descriptive aim, with no hypothesis.
Applicable Disease Sites
Any Site
Status
Open
Participating Institutions
Hershey Medical Center