Physical Activity Post-Cancer for Adolescents and Young Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physical Activity Post-Cancer for Adolescents and Young Adults (PAPAYA)

Conditions
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Childhood Cancer Survivors

Intervention / Treatment
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* Behavioral: Physical Activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescent and young adult inclusion criteria will be as follows: males and females diagnosed with cancer; treated at Penn State Health Children's Hospital or Penn State Cancer Institute, Milton S. Hershey Medical Center; at least 1 year and up to 5 years post-cancer treatment; being aged between 10 to 17 years old at enrollment; being able to speak, read and understand the English language; adolescents and young adults have to be able to assent, and parents/guardians have to be able to consent to the study in an informed manner; Parent fluency in written and spoken English; Adolescents and young adults or their parents must have access to a phone or Zoom Note: The agreement of the attending oncologist will be required for the participation of adolescents and young adults eligible for this study. Exclusion Criteria: Adolescent and young adult exclusion criteria will be as follows: Received follow-up at a location other than Penn State Health Children's Hospital or Penn State Cancer Institute, Milton S. Hershey Medical Center; Evidence in the medical record of an absolute contraindication for physical activity; cardiac exclusion criteria: Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system, history of acute coronary syndromes, uncertain or uncontrolled arrhythmia, uncontrolled hypertension, syncope, acute myocarditis, pericarditis, or endocarditis, acute pulmonary embolus or pulmonary infarction, thrombosis of lower extremities, suspected dissecting aneurysm, pulmonary edema, respiratory failure, acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise, mental impairment leading to inability to cooperate; History of refractory or recurrent diseases Already meeting physical activity guidelines.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial, utilizing a delayed-intervention control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity intervention group<br>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 to improve compliance to physical activity intervention. | Behavioral: Physical Activity<br>* 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.<br>|
| Other: Delayed-intervention control group<br>Participants randomized to the delayed-intervention control group will serve as the control group for 12 weeks, and will not receive physical activity intervention during this time and will not receive weekly support calls. After completion of the control group, participants will be offered physical activity advice according to the Children's Oncology Group Guidelines for Diet and Physical Activity recommendations. This delayed-intervention control group design is used not only to boost recruitment, but to eventually confer the benefits of physical activity to all those who enter the trial. | Behavioral: Physical Activity<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability-the proportion of adolescents and young adults who agree to participate | The proportion of adolescents and young adults who agree to participate among those deemed eligible by the attending oncologist Range 0-100%-Higher scores indicate greater acceptability | Baseline | 
| Feasibility-the proportion of adolescents and young adults who complete at least 50% of the physical activity intervention | The percentage of those randomized to the physical activity intervention that complete at least 50% of the physical activity intervention. Participants will be instructed by a project manager during weekly support calls to accumulate a specific amount of physical activity each week. Participants who self-report completing at least 50% of the physical activity, determined by the Godin-Shephard Leisure-Time Physical Activity Questionnaire, will be deemed compliant. Range 0-100%-Higher scores indicate greater feasibility | Baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes-physical function mobility | the physical function mobility assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 8-40, higher scores indicate greater physical function mobility | Baseline | 
| Patient reported outcomes-physical function mobility | the physical function mobility assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 8-40, higher scores indicate greater physical function mobility | week 12 | 
| Patient reported outcomes-anxiety | the anxiety assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 8-40, higher scores indicate greater anxiety | Baseline | 
| Patient reported outcomes-anxiety | the anxiety assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 8-40, higher scores indicate greater anxiety | Week 12 | 
| Patient reported outcomes-depressive symptoms | the depressive symptoms assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 8-40, higher scores indicate greater depressive symptoms | baseline | 
| Patient reported outcomes-depressive symptoms | the depressive symptoms assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 8-40, higher scores indicate greater depressive symptoms | Week 12 | 
| Patient reported outcomes-fatigue | the fatigue assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 8-40, higher scores indicate greater fatigue | baseline | 
| Patient reported outcomes-fatigue | the fatigue assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 8-40, higher scores indicate greater fatigue | week 12 | 
| Patient reported outcomes-peer relationships | the peer relationships assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 8-40, higher scores indicate greater peer relationships | baseline | 
| Patient reported outcomes-peer relationships | the peer relationships assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 8-40, higher scores indicate greater peer relationships | week 12 | 
| Patient reported outcomes-social isolation | the social isolation assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 8-40, higher scores indicate greater social isolation | baseline | 
| Patient reported outcomes-social isolation | the social isolation assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 8-40, higher scores indicate greater social isolation | week 12 | 
| Patient reported outcomes-pain interference | the pain interference assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 8-40, higher scores indicate greater pain interference | baseline | 
| Patient reported outcomes-pain interference | the pain interference assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 8-40, higher scores indicate greater pain interference | week 12 | 
| Patient reported outcomes-pain intensity | the pain intensity assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 0-10, higher scores indicate greater pain intensity | baseline | 
| Patient reported outcomes-pain intensity | the pain intensity assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 0-10, higher scores indicate greater pain intensity | week 12 | 
| Patient reported outcomes-sleep disturbance | the sleep disturbance assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 8-40, higher scores indicate greater sleep disturbance | baseline | 
| Patient reported outcomes-sleep disturbance | the sleep disturbance assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 8-40, higher scores indicate greater sleep disturbance | week 12 | 
| Patient reported outcomes-cognitive function | the cognitive function assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 7-35, higher scores indicate greater cognitive function | baseline | 
| Patient reported outcomes-cognitive function | the cognitive function assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49) Range 7-35, higher scores indicate greater cognitive function | week 12 | 
| physical function-six minute walking test | The six minute walking test will be administered to assess physical function. Participants will aim to walk as far as possible for 6 minutes. Further distances indicate greater physical function | baseline | 
| physical function-six minute walking test | The six minute walking test will be administered to assess physical function. Participants will aim to walk as far as possible for 6 minutes. Further distances indicate greater physical function | week 12 | 
| physical function-30 second chair stand | The 30 second chair stand test will be administered to assess physical function. Participants will aim to sit and rise out of a chair as many times as possible in 30 seconds. Greater amounts of sit/stands indicate greater physical function | baseline | 
| physical function-30 second chair stand | The 30 second chair stand test will be administered to assess physical function. Participants will aim to sit and rise out of a chair as many times as possible in 30 seconds. Greater amounts of sit/stands indicate greater physical function | week 12 | 
| physical function-timed up and go | The timed up and go test will be administered to assess physical function. Participants will aim to stand up, walk 3 meters, turn around, and walk back to the chair as fast as possible. Shorter durations indicate greater physical function | baseline | 
| physical function-timed up and go | The timed up and go test will be administered to assess physical function. Participants will aim to stand up, walk 3 meters, turn around, and walk back to the chair as fast as possible. Shorter durations indicate greater physical function | week 12 |