Physical Activity Post-Cancer for Adolescents and Young Adults
Condition: Childhood Cancer Survivors
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      The investigators will recruit 40 adolescents and young adults at least 1 year, and up to 5
      years post-cancer treatment, and randomize them (20 randomized to each condition) to either a
      12-week physical activity intervention to improve patient-reported outcomes and physical
      function, or delayed-intervention control group.

      Participants randomized to the intervention group: The physical activity intervention will be
      structured to increase moderate-to-vigorous intensity aerobic physical activity, to achieve
      the 60 minute goal, five days per week. The intervention will also include weekly support
      calls from research staff. The physical activity intervention will be individualized by
      research staff according to the adolescents and young adults' health status, results from the
      physical fitness assessment, and most recent week's achieved minutes. The physical activity
      intervention will be modified during weekly support calls with a study team member, including
      frequency, intensity, time, and type, to maximize adherence and compliance

      Participants randomized to the delayed-intervention control group: They will not receive the
      physical activity intervention, and they will not receive weekly support calls. Physical
      activity advice according to the Children's Oncology Group Guidelines for Diet and Physical
      Activity recommendations will be offered to participants randomized to the
      delayed-intervention control group following completion of 12-week follow-up.
    

Intervention name(s): Physical Activity
Intervention type(s): Behavioral
Intervention description(s): The main structure of the physical activity program will focus on increasing physical activity. Physical activity will initially start at a duration of 15-30 minute bouts, and at rate of perceived exertion levels of 5-6 (somewhat hard). Over the course of the intervention, goals will be set to progress to 60 minutes of continuous physical activity, at a rate of perceived exertion level of 5-6 (somewhat hard). Participants will be instructed on the use of the ratings of the perceived exertion scale (Borg's RPE 1-10 scale). Participants will be instructed to walk, or engage in other forms of leisure-time physical activity to achieve these goals (cycling, running, swimming, etc). As the adolescent and young adults' health and fitness status improve, frequency, intensity, and session duration will be modified accordingly during weekly support calls. Moreover, goals will be responsive to the most recent week's achieved minutes and rate of perceived exertion.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial, utilizing a delayed-intervention control group.
Masking: None (Open Label)
Primary purpose: Supportive Care